Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study

June 2, 2026 updated by: National Cancer Institute (NCI)

MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of ADjuvant ThErapy in URothelial CaNcer

This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. In this study, a blood test is used to measure ctDNA and see if there is still cancer somewhere in the body after surgery and if giving a treatment will help eliminate the cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and relatlimab, can help the body's immune system to attack the cancer, and can interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine if ctDNA measurement in blood can better identify patients that need additional treatment, if treatment with nivolumab prolongs patients' life and whether the additional immunotherapy treatment with relatlimab extends time without disease progression or prolongs life of urothelial cancer patients who have undergone surgical removal of their bladder, kidney, ureter or urethra.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To compare the ctDNA clearance proportion (i.e., ctDNA positive [+] --> ctDNA negative [-]) at 12 weeks in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab (phase 2 portion).

II. To compare overall survival in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab (phase 3 portion).

III. To compare disease-free survival in patients enrolled in Cohort B randomized to immediate treatment with nivolumab to those randomized to surveillance with subsequent treatment with nivolumab only upon converting to ctDNA(+)

SECONDARY OBJECTIVES:

I. To compare disease-free survival in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab.

II. To define the association between ctDNA clearance and disease-free survival and overall survival for Cohort A patients.

III. To compare overall survival in patients enrolled in Cohort B randomized to immediate treatment with nivolumab to those randomized to surveillance with subsequent treatment with nivolumab only upon converting to ctDNA(+).

IV. To determine the lead time from a ctDNA(+) assay to radiographic recurrence in patients initially ctDNA(-) post-definitive surgery enrolled in Cohort B.

V. To estimate the proportion of Cohort B patients on Arm 4 who become ctDNA(+) and receive nivolumab.

VI. To compare the cumulative incidence of Cohort B patients who become ctDNA(+) between Arms 3 and 4.

VII. To determine the safety of adjuvant nivolumab plus relatlimab. VIII. To compare disease-free survival and overall survival in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab according to receipt of neoadjuvant immune checkpoint blockade-containing therapy versus no neoadjuvant immune checkpoint blockade-containing therapy.

IX. To compare disease-free survival and overall survival in patients enrolled in Cohort B treated with adjuvant nivolumab versus nivolumab + relatlimab according to receipt of neoadjuvant immune checkpoint blockade-containing therapy versus no neoadjuvant immune checkpoint blockade-containing therapy.

EXPLORATORY OBJECTIVES:

I. To explore the kinetics of quantitative ctDNA levels (mean number of tumor molecules observed per mL of plasma or MTM/ml) over time and the association between ctDNA kinetics and time-to-event outcomes.

II. To estimate the costs and value of care in patients with a ctDNA(+) assay post-radical surgery treated with adjuvant nivolumab versus nivolumab + relatlimab.

III. To estimate the costs and value of care in patients with a ctDNA(-) assay post-radical surgery treated with adjuvant nivolumab versus surveillance with subsequent treatment with nivolumab at the time of conversion to ctDNA(+).

QUALITY OF LIFE OBJECTIVES:

I. Within each cohort, to compare quality-adjusted survival among randomized arms using European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L).

II. Within Cohort B, to compare overall quality of life (QOL) as measured by the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) between baseline and 42 months (calculated as the area under the curve) among randomized arms.

III. Within each cohort, to compare overall QOL as measured by the EORTC QLQ-C30 at each time point among randomized arms.

IV. Within each cohort, to compare bladder cancer-specific QOL as measured by the EORTC Bladder Cancer Muscle-Invasive 30 Questionnaire (QLQ-BLM30) at each time point among randomized arms.

V. Within each cohort, to compare patient-reported fatigue as measured by Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue at each time point among randomized arms.

OUTLINE: Patients are assigned to 1 of 2 cohorts based on ctDNA results.

COHORT A: Patients who are ctDNA(+) are randomized to 1 of 2 arms:

ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) and may undergo cystoscopy throughout the trial.

ARM II: Patients receive nivolumab IV over 30 minutes and relatlimab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI and may undergo cystoscopy throughout the trial.

COHORT B: Patients who are ctDNA(-) are randomized to 1 of 2 arms:

ARM III: Patients receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI and may undergo cystoscopy throughout the trial.

ARM IV: Patients undergo ctDNA surveillance consisting of collection of tissue and blood during screening and collection of blood only on study and during follow up. Patients who convert to ctDNA(+) during surveillance then receive nivolumab IV over 30 minutes day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI and may undergo cystoscopy throughout the trial.

After completion of study treatment, patients are followed up at weeks 48, 60, 72, 84, 96, 120, 144, 196, and 248.

Study Type

Interventional

Enrollment (Estimated)

992

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Recruiting
        • Arthur J E Child Comprehensive Cancer Centre
        • Contact:
        • Principal Investigator:
          • Nimira S. Alimohamed
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Recruiting
        • Cross Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 780-432-8500
        • Principal Investigator:
          • Scott A. North
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • BCCA-Vancouver Cancer Centre
        • Contact:
          • Site Public Contact
          • Phone Number: 888-939-3333
        • Principal Investigator:
          • Bernie (Bernhard) J. Eigl
    • Ontario
      • Kitchener, Ontario, Canada, N2G 1G3
        • Recruiting
        • Waterloo Regional Health Network
        • Principal Investigator:
          • Anupam Batra
        • Contact:
      • London, Ontario, Canada, N6A 4L6
        • Recruiting
        • London Regional Cancer Program
        • Contact:
          • Site Public Contact
          • Phone Number: 519-685-8600
        • Principal Investigator:
          • Melissa Huynh
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • Ottawa Hospital and Cancer Center-General Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 613-761-4395
        • Principal Investigator:
          • Ana-Alicia Beltran-Bless
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Odette Cancer Centre- Sunnybrook Health Sciences Centre
        • Contact:
          • Site Public Contact
          • Phone Number: 416-480-5000
        • Principal Investigator:
          • Susanna Y. Cheng
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • University Health Network-Princess Margaret Hospital
        • Contact:
        • Principal Investigator:
          • Srikala S. Sridhar
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic Hospital in Arizona
        • Principal Investigator:
          • Arnab Basu
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • Banner University Medical Center - Tucson
        • Contact:
        • Principal Investigator:
          • Edward P. Gelmann
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • University of Arizona Cancer Center-North Campus
        • Contact:
        • Principal Investigator:
          • Edward P. Gelmann
      • Tucson, Arizona, United States, 85704
        • Suspended
        • University of Arizona Cancer Center-Orange Grove Campus
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Recruiting
        • Highlands Oncology Group - Fayetteville
        • Principal Investigator:
          • Joseph T. Beck
        • Contact:
      • Rogers, Arkansas, United States, 72758
        • Recruiting
        • Highlands Oncology Group - Rogers
        • Principal Investigator:
          • Joseph T. Beck
        • Contact:
      • Springdale, Arkansas, United States, 72762
        • Recruiting
        • Highlands Oncology Group
        • Principal Investigator:
          • Joseph T. Beck
        • Contact:
    • California
      • Anaheim, California, United States, 92806
        • Recruiting
        • Kaiser Permanente-Anaheim
        • Contact:
        • Principal Investigator:
          • Helen H. Moon
      • Baldwin Park, California, United States, 91706
        • Recruiting
        • Kaiser Permanente-Baldwin Park
        • Contact:
        • Principal Investigator:
          • Helen H. Moon
      • Bellflower, California, United States, 90706
        • Recruiting
        • Kaiser Permanente-Bellflower
        • Contact:
        • Principal Investigator:
          • Helen H. Moon
      • Dublin, California, United States, 94568
        • Recruiting
        • Kaiser Permanente Dublin
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
      • Fontana, California, United States, 92335
        • Recruiting
        • Kaiser Permanente-Fontana
        • Contact:
        • Principal Investigator:
          • Helen H. Moon
      • Fremont, California, United States, 94538
        • Recruiting
        • Kaiser Permanente-Fremont
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Fresno, California, United States, 93720
        • Recruiting
        • Kaiser Permanente-Fresno
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Fresno, California, United States, 93720
        • Recruiting
        • Kaiser Permanente Fresno Orchard Plaza
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 833-574-2273
      • Harbor City, California, United States, 90710
        • Recruiting
        • Kaiser Permanente South Bay
        • Contact:
        • Principal Investigator:
          • Helen H. Moon
      • Irvine, California, United States, 92618
        • Recruiting
        • Kaiser Permanente-Irvine
        • Contact:
        • Principal Investigator:
          • Helen H. Moon
      • La Jolla, California, United States, 92093
        • Recruiting
        • UC San Diego Moores Cancer Center
        • Contact:
        • Principal Investigator:
          • Tyler Stewart
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA / Jonsson Comprehensive Cancer Center
        • Principal Investigator:
          • Alexandra Drakaki
        • Contact:
          • Site Public Contact
          • Phone Number: 888-798-0719
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Kaiser Permanente Los Angeles Medical Center
        • Contact:
        • Principal Investigator:
          • Helen H. Moon
      • Los Angeles, California, United States, 90034
        • Recruiting
        • Kaiser Permanente West Los Angeles
        • Contact:
        • Principal Investigator:
          • Helen H. Moon
      • Los Angeles, California, United States, 90033
        • Active, not recruiting
        • USC / Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90020
        • Active, not recruiting
        • Keck Medicine of USC Koreatown
      • Los Angeles, California, United States, 90033
        • Active, not recruiting
        • Los Angeles General Medical Center
      • Modesto, California, United States, 95356
        • Recruiting
        • Kaiser Permanente-Modesto
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Modesto, California, United States, 95356
        • Recruiting
        • Kaiser Permanente- Modesto MOB II
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
      • Newport Beach, California, United States, 92663
        • Active, not recruiting
        • USC Norris Oncology/Hematology-Newport Beach
      • Oakland, California, United States, 94611
        • Recruiting
        • Kaiser Permanente-Oakland
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Ontario, California, United States, 91761
        • Recruiting
        • Kaiser Permanente-Ontario
        • Contact:
        • Principal Investigator:
          • Helen H. Moon
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Cancer Institute Palo Alto
        • Principal Investigator:
          • Ali R. Khaki
        • Contact:
      • Panorama City, California, United States, 91402
        • Recruiting
        • Kaiser Permanente - Panorama City
        • Contact:
        • Principal Investigator:
          • Helen H. Moon
      • Riverside, California, United States, 92505
        • Recruiting
        • Kaiser Permanente-Riverside
        • Contact:
        • Principal Investigator:
          • Helen H. Moon
      • Roseville, California, United States, 95661
        • Recruiting
        • Kaiser Permanente-Roseville
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 916-734-3089
        • Principal Investigator:
          • Mamta Parikh
      • Sacramento, California, United States, 95814
        • Recruiting
        • Kaiser Permanente Downtown Commons
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Sacramento, California, United States, 95823
        • Recruiting
        • Kaiser Permanente-South Sacramento
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • San Diego, California, United States, 92120
        • Recruiting
        • Kaiser Permanente-San Diego Zion
        • Contact:
        • Principal Investigator:
          • Helen H. Moon
      • San Francisco, California, United States, 94115
        • Recruiting
        • Kaiser Permanente-San Francisco
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • San Jose, California, United States, 95119
        • Recruiting
        • Kaiser Permanente-Santa Teresa-San Jose
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • San Leandro, California, United States, 94577
        • Recruiting
        • Kaiser Permanente San Leandro
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • San Marcos, California, United States, 92078
        • Recruiting
        • Kaiser Permanente-San Marcos
        • Contact:
        • Principal Investigator:
          • Helen H. Moon
      • San Rafael, California, United States, 94903
        • Recruiting
        • Kaiser San Rafael-Gallinas
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Santa Clara, California, United States, 95051
        • Recruiting
        • Kaiser Permanente Medical Center - Santa Clara
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Santa Monica, California, United States, 90404
        • Suspended
        • Saint John's Cancer Institute
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Kaiser Permanente-Santa Rosa
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • South San Francisco, California, United States, 94080
        • Recruiting
        • Kaiser Permanente-South San Francisco
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Vallejo, California, United States, 94589
        • Recruiting
        • Kaiser Permanente-Vallejo
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Walnut Creek, California, United States, 94596
        • Recruiting
        • Kaiser Permanente-Walnut Creek
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Woodland Hills, California, United States, 91367
        • Recruiting
        • Kaiser Permanente-Woodland Hills
        • Contact:
        • Principal Investigator:
          • Helen H. Moon
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • UCHealth University of Colorado Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 720-848-0650
        • Principal Investigator:
          • Elizabeth R. Kessler
      • Denver, Colorado, United States, 80205
        • Recruiting
        • Kaiser Permanente-Franklin
        • Principal Investigator:
          • Matthew J. Eadens
        • Contact:
      • Fort Collins, Colorado, United States, 80524
        • Recruiting
        • Poudre Valley Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 970-297-6150
        • Principal Investigator:
          • Elizabeth R. Kessler
      • Fort Collins, Colorado, United States, 80528
        • Recruiting
        • Cancer Care and Hematology-Fort Collins
        • Contact:
        • Principal Investigator:
          • Elizabeth R. Kessler
      • Greeley, Colorado, United States, 80631
        • Recruiting
        • UCHealth Greeley Hospital
        • Contact:
        • Principal Investigator:
          • Elizabeth R. Kessler
      • Highlands Ranch, Colorado, United States, 80129
        • Recruiting
        • UCHealth Highlands Ranch Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 720-848-0650
        • Principal Investigator:
          • Elizabeth R. Kessler
      • Lafayette, Colorado, United States, 80026
        • Recruiting
        • Kaiser Permanente-Rock Creek
        • Principal Investigator:
          • Matthew J. Eadens
        • Contact:
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • Kaiser Permanente-Lone Tree
        • Principal Investigator:
          • Matthew J. Eadens
        • Contact:
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • UCHealth Lone Tree Health Center
        • Contact:
        • Principal Investigator:
          • Elizabeth R. Kessler
      • Loveland, Colorado, United States, 80538
        • Recruiting
        • Medical Center of the Rockies
        • Contact:
          • Site Public Contact
          • Phone Number: 970-203-7083
        • Principal Investigator:
          • Elizabeth R. Kessler
    • Connecticut
      • Avon, Connecticut, United States, 06001
        • Recruiting
        • Hartford HealthCare - Avon
        • Contact:
          • Site Public Contact
          • Phone Number: 860-972-4700
        • Principal Investigator:
          • Michael Sun
      • Bridgeport, Connecticut, United States, 06606
        • Recruiting
        • Hartford HealthCare - Saint Vincent's Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 860-972-4700
        • Principal Investigator:
          • Michael Sun
      • Derby, Connecticut, United States, 06418
        • Recruiting
        • Smilow Cancer Hospital-Derby Care Center
        • Contact:
        • Principal Investigator:
          • Joseph W. Kim
      • Fairfield, Connecticut, United States, 06824
        • Recruiting
        • Smilow Cancer Hospital Care Center-Fairfield
        • Contact:
        • Principal Investigator:
          • Joseph W. Kim
      • Fairfield, Connecticut, United States, 06824
        • Recruiting
        • Hartford Healthcare - Fairfield
        • Principal Investigator:
          • Michael Sun
        • Contact:
      • Glastonbury, Connecticut, United States, 06033
        • Recruiting
        • Smilow Cancer Hospital Care Center at Glastonbury
        • Contact:
        • Principal Investigator:
          • Joseph W. Kim
      • Greenwich, Connecticut, United States, 06830
        • Recruiting
        • Smilow Cancer Hospital Care Center at Greenwich
        • Contact:
        • Principal Investigator:
          • Joseph W. Kim
      • Guilford, Connecticut, United States, 06437
        • Recruiting
        • Smilow Cancer Hospital Care Center - Guilford
        • Contact:
        • Principal Investigator:
          • Joseph W. Kim
      • Hartford, Connecticut, United States, 06105
        • Recruiting
        • Smilow Cancer Hospital Care Center at Saint Francis
        • Contact:
        • Principal Investigator:
          • Joseph W. Kim
      • Hartford, Connecticut, United States, 06102
        • Recruiting
        • Hartford Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 860-545-5363
        • Principal Investigator:
          • Michael Sun
      • Manchester, Connecticut, United States, 06042
        • Recruiting
        • Hartford HealthCare - Manchester
        • Contact:
          • Site Public Contact
          • Phone Number: 860-972-4700
        • Principal Investigator:
          • Michael Sun
      • Meriden, Connecticut, United States, 06451
        • Recruiting
        • Midstate Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 866-662-5678
        • Principal Investigator:
          • Michael Sun
      • New Britain, Connecticut, United States, 06050
        • Recruiting
        • The Hospital of Central Connecticut
        • Contact:
          • Site Public Contact
          • Phone Number: 860-224-5660
        • Principal Investigator:
          • Michael Sun
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University
        • Contact:
        • Principal Investigator:
          • Joseph W. Kim
      • North Haven, Connecticut, United States, 06473
        • Recruiting
        • Yale-New Haven Hospital North Haven Medical Center
        • Contact:
        • Principal Investigator:
          • Joseph W. Kim
      • Stamford, Connecticut, United States, 06902
        • Recruiting
        • Smilow Cancer Hospital Care Center at Long Ridge
        • Contact:
        • Principal Investigator:
          • Joseph W. Kim
      • Torrington, Connecticut, United States, 06790
        • Recruiting
        • Smilow Cancer Hospital-Torrington Care Center
        • Contact:
        • Principal Investigator:
          • Joseph W. Kim
      • Trumbull, Connecticut, United States, 06611
        • Recruiting
        • Smilow Cancer Hospital Care Center-Trumbull
        • Contact:
        • Principal Investigator:
          • Joseph W. Kim
      • Waterbury, Connecticut, United States, 06708
        • Recruiting
        • Smilow Cancer Hospital-Waterbury Care Center
        • Contact:
        • Principal Investigator:
          • Joseph W. Kim
      • Waterford, Connecticut, United States, 06385
        • Recruiting
        • Smilow Cancer Hospital Care Center - Waterford
        • Contact:
        • Principal Investigator:
          • Joseph W. Kim
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Helen F Graham Cancer Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Medical Oncology Hematology Consultants PA
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016
        • Recruiting
        • Sibley Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Jean H. Hoffman-Censits
      • Washington D.C., District of Columbia, United States, 20007
        • Recruiting
        • MedStar Georgetown University Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 202-444-2223
        • Principal Investigator:
          • Nicholas I. Simon
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • Medstar Washington Hospital Center
        • Contact:
          • Site Public Contact
          • Phone Number: 202-877-8839
        • Principal Investigator:
          • Nicholas I. Simon
      • Washington D.C., District of Columbia, United States, 20037
        • Recruiting
        • George Washington University Medical Center
        • Principal Investigator:
          • Karan Jatwani
        • Contact:
          • Site Public Contact
          • Phone Number: 202-741-2210
    • Florida
      • Aventura, Florida, United States, 33180
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Aventura
        • Contact:
          • Site Public Contact
          • Phone Number: 954-461-2180
        • Principal Investigator:
          • Janaki N. Sharma
      • Aventura, Florida, United States, 33180
        • Recruiting
        • Mount Sinai Comprehensive Cancer Center at Aventura
        • Contact:
        • Principal Investigator:
          • Oleg Gligich
      • Coral Gables, Florida, United States, 33146
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Janaki N. Sharma
      • Deerfield Beach, Florida, United States, 33442
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Janaki N. Sharma
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • Malcom Randall Veterans Administration Medical Center
        • Contact:
        • Principal Investigator:
          • Jess DeLaune
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • UF Health Cancer Institute - Gainesville
        • Contact:
        • Principal Investigator:
          • Daniel V. Araujo
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 954-265-1847
          • Email: OHR@mhs.net
        • Principal Investigator:
          • Matthew P. Salzberg
      • Jacksonville, Florida, United States, 32224-9980
        • Suspended
        • Mayo Clinic in Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Janaki N. Sharma
      • Miami, Florida, United States, 33176
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Kendall
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Janaki N. Sharma
      • Miami, Florida, United States, 33176
        • Recruiting
        • Miami Cancer Institute
        • Principal Investigator:
          • Rohan Garje
        • Contact:
          • Site Public Contact
          • Phone Number: 786-596-2000
      • Miami Beach, Florida, United States, 33140
        • Suspended
        • Mount Sinai Medical Center
      • North Miami, Florida, United States, 33181
        • Recruiting
        • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
        • Principal Investigator:
          • Janaki N. Sharma
        • Contact:
      • Orlando, Florida, United States, 32803
        • Recruiting
        • AdventHealth Orlando
        • Contact:
        • Principal Investigator:
          • Guru P. Sonpavde
      • Pembroke Pines, Florida, United States, 33028
        • Recruiting
        • Memorial Hospital West
        • Contact:
          • Site Public Contact
          • Phone Number: 954-265-4325
        • Principal Investigator:
          • Matthew P. Salzberg
      • Plantation, Florida, United States, 33324
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Plantation
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Janaki N. Sharma
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital/Winship Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 404-778-1868
        • Principal Investigator:
          • Jacqueline T. Brown
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Northside Hospital
        • Contact:
        • Principal Investigator:
          • Louis C. Garrot
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Grady Health System
        • Contact:
          • Site Public Contact
          • Phone Number: 404-778-1868
        • Principal Investigator:
          • Jacqueline T. Brown
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
        • Contact:
          • Site Public Contact
          • Phone Number: 888-946-7447
        • Principal Investigator:
          • Jacqueline T. Brown
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Emory Saint Joseph's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 404-851-7115
        • Principal Investigator:
          • Jacqueline T. Brown
      • Duluth, Georgia, United States, 30096
        • Recruiting
        • Northside Hospital - Duluth
        • Contact:
        • Principal Investigator:
          • Louis C. Garrot
      • Johns Creek, Georgia, United States, 30097
        • Recruiting
        • Emory Johns Creek Hospital
        • Principal Investigator:
          • Jacqueline T. Brown
        • Contact:
      • Lawrenceville, Georgia, United States, 30046
        • Recruiting
        • Northside Hospital - Gwinnett
        • Contact:
        • Principal Investigator:
          • Louis C. Garrot
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • Recruiting
        • Kaiser Permanente Moanalua Medical Center
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
    • Idaho
      • Boise, Idaho, United States, 83706
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Boise
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Caldwell, Idaho, United States, 83605
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Caldwell
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Coeur d'Alene, Idaho, United States, 83814
        • Recruiting
        • Kootenai Health - Coeur d'Alene
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Nampa, Idaho, United States, 83687
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Nampa
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Post Falls, Idaho, United States, 83854
        • Recruiting
        • Kootenai Clinic Cancer Services - Post Falls
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Sandpoint, Idaho, United States, 83864
        • Recruiting
        • Kootenai Clinic Cancer Services - Sandpoint
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • Illinois
      • Barrington, Illinois, United States, 60010
        • Recruiting
        • Advocate Good Shepherd Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-842-4847
        • Principal Investigator:
          • Adam P. Siegel
      • Bloomington, Illinois, United States, 61704
        • Recruiting
        • Illinois CancerCare-Bloomington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Canton, Illinois, United States, 61520
        • Recruiting
        • Illinois CancerCare-Canton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Carthage, Illinois, United States, 62321
        • Recruiting
        • Illinois CancerCare-Carthage
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Randy F. Sweis
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • David VanderWeele
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois
        • Contact:
          • Site Public Contact
          • Phone Number: 312-355-3046
        • Principal Investigator:
          • Natalie Reizine
      • Chicago, Illinois, United States, 60657
        • Recruiting
        • Advocate Illinois Masonic Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 773-296-5360
        • Principal Investigator:
          • Adam P. Siegel
      • Chicago, Illinois, United States, 60625
        • Recruiting
        • Swedish Covenant Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 773-878-8200
        • Principal Investigator:
          • Nicklas R. Pfanzelter
      • Crystal Lake, Illinois, United States, 60014
        • Recruiting
        • AMG Crystal Lake - Oncology
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • DeKalb, Illinois, United States, 60115
        • Recruiting
        • Northwestern Medicine Cancer Center Kishwaukee
        • Contact:
        • Principal Investigator:
          • David VanderWeele
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois - Decatur
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Decatur Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Dixon, Illinois, United States, 61021
        • Recruiting
        • Illinois CancerCare-Dixon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 815-285-7800
      • Downers Grove, Illinois, United States, 60515
        • Recruiting
        • Advocate Good Samaritan Hospital
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Carle Physician Group-Effingham
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Crossroads Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Elgin, Illinois, United States, 60123
        • Recruiting
        • Advocate Sherman Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-429-2907
        • Principal Investigator:
          • Adam P. Siegel
      • Elmhurst, Illinois, United States, 60126
        • Active, not recruiting
        • Elmhurst Memorial Hospital
      • Eureka, Illinois, United States, 61530
        • Recruiting
        • Illinois CancerCare-Eureka
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • NorthShore University HealthSystem-Evanston Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-570-2109
        • Principal Investigator:
          • Nicklas R. Pfanzelter
      • Galesburg, Illinois, United States, 61401
        • Recruiting
        • Illinois CancerCare-Galesburg
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Geneva, Illinois, United States, 60134
        • Recruiting
        • Northwestern Medicine Cancer Center Delnor
        • Contact:
        • Principal Investigator:
          • David VanderWeele
      • Glenview, Illinois, United States, 60026
        • Recruiting
        • NorthShore University HealthSystem-Glenbrook Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-570-2109
        • Principal Investigator:
          • Nicklas R. Pfanzelter
      • Glenview, Illinois, United States, 60026
        • Recruiting
        • Northwestern Medicine Glenview Outpatient Center
        • Principal Investigator:
          • David VanderWeele
        • Contact:
          • Site Public Contact
          • Phone Number: 312-695-1102
      • Grayslake, Illinois, United States, 60030
        • Recruiting
        • Northwestern Medicine Grayslake Outpatient Center
        • Principal Investigator:
          • David VanderWeele
        • Contact:
          • Site Public Contact
          • Phone Number: 312-695-1102
      • Harvey, Illinois, United States, 60426
        • Recruiting
        • Ingalls Memorial Hospital
        • Principal Investigator:
          • James A. Wallace
        • Contact:
      • Hazel Crest, Illinois, United States, 60429
        • Recruiting
        • Advocate South Suburban Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 708-799-9995
        • Principal Investigator:
          • Adam P. Siegel
      • Highland Park, Illinois, United States, 60035
        • Recruiting
        • NorthShore University HealthSystem-Highland Park Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-570-2109
        • Principal Investigator:
          • Nicklas R. Pfanzelter
      • Kewanee, Illinois, United States, 61443
        • Recruiting
        • Illinois CancerCare-Kewanee Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Lake Forest, Illinois, United States, 60045
        • Recruiting
        • Northwestern Medicine Lake Forest Hospital
        • Contact:
        • Principal Investigator:
          • David VanderWeele
      • Libertyville, Illinois, United States, 60048
        • Recruiting
        • AMG Libertyville - Oncology
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Libertyville, Illinois, United States, 60048
        • Recruiting
        • Condell Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Macomb, Illinois, United States, 61455
        • Recruiting
        • Illinois CancerCare-Macomb
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Mattoon, Illinois, United States, 61938
        • Recruiting
        • Carle Physician Group-Mattoon/Charleston
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Naperville, Illinois, United States, 60540
        • Active, not recruiting
        • Edward Hospital/Cancer Center
      • New Lenox, Illinois, United States, 60451
        • Recruiting
        • UC Comprehensive Cancer Center at Silver Cross
        • Contact:
        • Principal Investigator:
          • Randy F. Sweis
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Cancer Care Center of O'Fallon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Oak Brook, Illinois, United States, 60523
      • Oak Lawn, Illinois, United States, 60453-2699
        • Recruiting
        • Advocate Christ Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-323-8622
        • Principal Investigator:
          • Adam P. Siegel
      • Orland Park, Illinois, United States, 60462
        • Recruiting
        • University of Chicago Medicine-Orland Park
        • Contact:
        • Principal Investigator:
          • Randy F. Sweis
      • Orland Park, Illinois, United States, 60462
      • Ottawa, Illinois, United States, 61350
        • Recruiting
        • Illinois CancerCare-Ottawa Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Park Ridge, Illinois, United States, 60068
        • Recruiting
        • Advocate Lutheran General Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-384-3621
        • Principal Investigator:
          • Adam P. Siegel
      • Pekin, Illinois, United States, 61554
        • Recruiting
        • Illinois CancerCare-Pekin
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peoria, Illinois, United States, 61615
        • Recruiting
        • Illinois CancerCare-Peoria
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peru, Illinois, United States, 61354
        • Recruiting
        • Illinois CancerCare-Peru
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Plainfield, Illinois, United States, 60585
        • Active, not recruiting
        • Edward Hospital/Cancer Center?Plainfield
      • Princeton, Illinois, United States, 61356
        • Recruiting
        • Illinois CancerCare-Princeton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Rockford, Illinois, United States, 61114
        • Recruiting
        • UW Health Carbone Cancer Center Rockford
        • Contact:
        • Principal Investigator:
          • Fahrettin Covut
      • Shiloh, Illinois, United States, 62269
        • Recruiting
        • Memorial Hospital East
        • Contact:
        • Principal Investigator:
          • Melissa A. Reimers
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 217-545-7929
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Springfield Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 800-444-7541
      • Springfield, Illinois, United States, 62781
        • Recruiting
        • Springfield Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • Northwestern Medicine Cancer Center Warrenville
        • Contact:
        • Principal Investigator:
          • David VanderWeele
      • Washington, Illinois, United States, 61571
        • Recruiting
        • Illinois CancerCare - Washington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
    • Indiana
      • Crown Point, Indiana, United States, 46307
        • Recruiting
        • UChicago Medicine Northwest Indiana
        • Principal Investigator:
          • Randy F. Sweis
        • Contact:
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University/Melvin and Bren Simon Cancer Center
        • Contact:
        • Principal Investigator:
          • Tareq Salous
    • Iowa
      • Ames, Iowa, United States, 50010
        • Recruiting
        • Mary Greeley Medical Center
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Ames, Iowa, United States, 50010
        • Recruiting
        • McFarland Clinic - Ames
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
      • Ankeny, Iowa, United States, 50023
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • Boone, Iowa, United States, 50036
        • Suspended
        • McFarland Clinic - Boone
      • Clive, Iowa, United States, 50325
        • Recruiting
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Mercy Medical Center - Des Moines
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Iowa Methodist Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-6727
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Fort Dodge, Iowa, United States, 50501
        • Recruiting
        • McFarland Clinic - Trinity Cancer Center
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa/Holden Comprehensive Cancer Center
        • Principal Investigator:
          • Fernando Maciel Barbosa
        • Contact:
          • Site Public Contact
          • Phone Number: 800-237-1225
      • Jefferson, Iowa, United States, 50129
        • Suspended
        • McFarland Clinic - Jefferson
      • Marshalltown, Iowa, United States, 50158
        • Recruiting
        • McFarland Clinic - Marshalltown
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Waukee, Iowa, United States, 50263
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Waukee Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
    • Kansas
      • Hays, Kansas, United States, 67601
        • Recruiting
        • HaysMed
        • Principal Investigator:
          • Saqib Abbasi
        • Contact:
          • Site Public Contact
          • Phone Number: 785-623-5774
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Cancer Center
        • Principal Investigator:
          • Saqib Abbasi
        • Contact:
      • Lawrence, Kansas, United States, 66044
        • Recruiting
        • Lawrence Memorial Hospital
        • Principal Investigator:
          • Saqib Abbasi
        • Contact:
      • Olathe, Kansas, United States, 66061
        • Recruiting
        • The University of Kansas Cancer Center - Olathe
        • Principal Investigator:
          • Saqib Abbasi
        • Contact:
      • Overland Park, Kansas, United States, 66210
        • Recruiting
        • University of Kansas Cancer Center-Overland Park
        • Principal Investigator:
          • Saqib Abbasi
        • Contact:
      • Salina, Kansas, United States, 67401
        • Recruiting
        • Salina Regional Health Center
        • Principal Investigator:
          • Saqib Abbasi
        • Contact:
      • Topeka, Kansas, United States, 66606
        • Recruiting
        • University of Kansas Health System Saint Francis Campus
        • Principal Investigator:
          • Saqib Abbasi
        • Contact:
          • Site Public Contact
          • Phone Number: 785-295-8000
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Hospital-Westwood Cancer Center
        • Principal Investigator:
          • Saqib Abbasi
        • Contact:
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky/Markey Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 859-257-3379
        • Principal Investigator:
          • Patrick J. Hensley
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • The James Graham Brown Cancer Center at University of Louisville
        • Principal Investigator:
          • Rohit Kumar
        • Contact:
          • Site Public Contact
          • Phone Number: 502-562-3429
      • Louisville, Kentucky, United States, 40245
        • Recruiting
        • UofL Health Medical Center Northeast
        • Principal Investigator:
          • Rohit Kumar
        • Contact:
      • Louisville, Kentucky, United States, 40207
        • Active, not recruiting
        • Baptist Health Louisville
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Recruiting
        • Louisiana Hematology Oncology Associates LLC
        • Contact:
        • Principal Investigator:
          • Scott E. Delacroix
      • Metairie, Louisiana, United States, 70002
        • Recruiting
        • Mary Bird Perkins Cancer Center - Metairie
        • Principal Investigator:
          • Scott E. Delacroix
        • Contact:
          • Site Public Contact
          • Phone Number: 504-584-6990
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Medical Center Jefferson
        • Contact:
        • Principal Investigator:
          • Brian T. Halbert
    • Maine
      • Brewer, Maine, United States, 04412
        • Recruiting
        • Lafayette Family Cancer Center-EMMC
        • Principal Investigator:
          • Sarah J. Sinclair
        • Contact:
          • Site Public Contact
          • Phone Number: 800-987-3005
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University/Sidney Kimmel Cancer Center
        • Contact:
        • Principal Investigator:
          • Jean H. Hoffman-Censits
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland/Greenebaum Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-888-8823
        • Principal Investigator:
          • Heather D. Mannuel
      • Cumberland, Maryland, United States, 21502
        • Recruiting
        • UPMC Western Maryland
        • Contact:
          • Site Public Contact
          • Phone Number: 240-964-1400
        • Principal Investigator:
          • Leonard J. Appleman
      • Frederick, Maryland, United States, 21702
        • Recruiting
        • FMH James M Stockman Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 301-668-7043
        • Principal Investigator:
          • Saro Sarkisian
    • Massachusetts
      • Beverly, Massachusetts, United States, 01915
        • Recruiting
        • Beverly Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 2405 978-922-3000
        • Principal Investigator:
          • Brendan Connell
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Principal Investigator:
          • Stephanie A. Berg
        • Contact:
          • Site Public Contact
          • Phone Number: 877-442-3324
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 617-667-9925
        • Principal Investigator:
          • Morgan Lichtenstein
      • Brighton, Massachusetts, United States, 02135
        • Recruiting
        • Dana-Farber Cancer Institute at Boston Medical Center - Brighton
        • Principal Investigator:
          • Olga Kozyreva
        • Contact:
          • Site Public Contact
          • Phone Number: 617-789-2903
      • Burlington, Massachusetts, United States, 01805
        • Recruiting
        • Lahey Hospital and Medical Center
        • Contact:
        • Principal Investigator:
          • Brendan Connell
      • Foxborough, Massachusetts, United States, 02035
        • Recruiting
        • Dana-Farber Cancer Institute at Foxborough
        • Principal Investigator:
          • Daniel Roberts
        • Contact:
          • Site Public Contact
          • Phone Number: 877-338-7425
      • Gloucester, Massachusetts, United States, 01930
        • Recruiting
        • Addison Gilbert Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 559 978-283-4000
        • Principal Investigator:
          • Brendan Connell
      • Milford, Massachusetts, United States, 01757
        • Recruiting
        • Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
        • Contact:
          • Site Public Contact
          • Phone Number: 877-332-4294
        • Principal Investigator:
          • Daniel E. Fein
      • Peabody, Massachusetts, United States, 01960
      • South Weymouth, Massachusetts, United States, 02190
        • Recruiting
        • Dana-Farber/Brigham and Women's Cancer Center at South Shore
        • Principal Investigator:
          • Shail Maingi
        • Contact:
          • Site Public Contact
          • Phone Number: 781-624-5000
      • Winchester, Massachusetts, United States, 01890
        • Active, not recruiting
        • Beth Israel Deaconess Medical Center/Winchester Center for Cancer Care
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Rogel Cancer Center
        • Principal Investigator:
          • Irene Tsung
        • Contact:
      • Ann Arbor, Michigan, United States, 48106
        • Recruiting
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Battle Creek, Michigan, United States, 49017
        • Recruiting
        • Bronson Battle Creek
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Bay City, Michigan, United States, 48706
        • Recruiting
        • McLaren Cancer Institute-Bay City
        • Contact:
        • Principal Investigator:
          • Yusra F. Shao
      • Brighton, Michigan, United States, 48114
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Brighton, Michigan, United States, 48116
        • Recruiting
        • University of Michigan - Brighton Center for Specialty Care
        • Contact:
          • Site Public Contact
          • Phone Number: 800-865-1125
        • Principal Investigator:
          • Irene Tsung
      • Brownstown, Michigan, United States, 48183
        • Recruiting
        • Henry Ford Cancer Institute-Downriver
        • Principal Investigator:
          • Clara Hwang
        • Contact:
      • Canton, Michigan, United States, 48188
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Chelsea, Michigan, United States, 48118
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Clinton Township, Michigan, United States, 48038
        • Recruiting
        • Henry Ford Macomb Hospital-Clinton Township
        • Principal Investigator:
          • Clara Hwang
        • Contact:
      • Dearborn, Michigan, United States, 48126
        • Recruiting
        • Henry Ford Medical Center-Fairlane
        • Principal Investigator:
          • Clara Hwang
        • Contact:
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Wayne State University/Karmanos Cancer Institute
        • Contact:
        • Principal Investigator:
          • Yusra F. Shao
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Principal Investigator:
          • Clara Hwang
        • Contact:
      • Escanaba, Michigan, United States, 49829
        • Recruiting
        • OSF Saint Francis Hospital and Medical Group
        • Principal Investigator:
          • Anthony J. Jaslowski
        • Contact:
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Weisberg Cancer Treatment Center
        • Contact:
        • Principal Investigator:
          • Yusra F. Shao
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesys Hurley Cancer Institute
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Hurley Medical Center
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Flint, Michigan, United States, 48503
        • Suspended
        • Genesee Hematology Oncology PC
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Cancer Hematology Centers - Flint
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Trinity Health Grand Rapids Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Jackson, Michigan, United States, 49201
        • Recruiting
        • Allegiance Health
        • Principal Investigator:
          • Clara Hwang
        • Contact:
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • Bronson Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • West Michigan Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Lansing, Michigan, United States, 48910
        • Recruiting
        • Karmanos Cancer Institute at McLaren Greater Lansing
        • Contact:
        • Principal Investigator:
          • Yusra F. Shao
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • University of Michigan Health - Sparrow Lansing
        • Principal Investigator:
          • Elie G. Dib
        • Contact:
      • Livonia, Michigan, United States, 48154
        • Recruiting
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Muskegon, Michigan, United States, 49444
        • Recruiting
        • Trinity Health Muskegon Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Niles, Michigan, United States, 49120
        • Recruiting
        • Corewell Health Lakeland Hospitals - Niles Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 616-391-1230
        • Principal Investigator:
          • Kathleen Y. Butler
      • Norton Shores, Michigan, United States, 49444
        • Recruiting
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Novi, Michigan, United States, 48377
        • Recruiting
        • Henry Ford Medical Center-Columbus
        • Principal Investigator:
          • Clara Hwang
        • Contact:
      • Petoskey, Michigan, United States, 49770
        • Recruiting
        • McLaren Cancer Institute-Northern Michigan
        • Contact:
        • Principal Investigator:
          • Yusra F. Shao
      • Pontiac, Michigan, United States, 48341
        • Recruiting
        • Trinity Health Saint Joseph Mercy Oakland Hospital
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Reed City, Michigan, United States, 49677
        • Recruiting
        • Corewell Health Reed City Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Saginaw, Michigan, United States, 48604
        • Suspended
        • Oncology Hematology Associates of Saginaw Valley PC
      • Saginaw, Michigan, United States, 48601
      • Saint Joseph, Michigan, United States, 49085
        • Recruiting
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Saint Joseph, Michigan, United States, 49085
        • Recruiting
        • Corewell Health Lakeland Hospitals - Saint Joseph Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Tawas City, Michigan, United States, 48764
      • Traverse City, Michigan, United States, 49684
        • Recruiting
        • Munson Medical Center
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • West Bloomfield, Michigan, United States, 48322
        • Recruiting
        • Henry Ford West Bloomfield Hospital
        • Principal Investigator:
          • Clara Hwang
        • Contact:
      • West Branch, Michigan, United States, 48661
        • Suspended
        • Saint Mary's Oncology/Hematology Associates of West Branch
      • Wyandotte, Michigan, United States, 48192
        • Recruiting
        • Henry Ford Wyandotte Hospital
        • Principal Investigator:
          • Clara Hwang
        • Contact:
      • Wyoming, Michigan, United States, 49519
        • Recruiting
        • University of Michigan Health - West
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Mercy Hospital
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Fairview Southdale Hospital
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott-Northwestern Hospital
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Minneapolis, Minnesota, United States, 55415
        • Recruiting
        • Hennepin County Medical Center
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Saint Cloud, Minnesota, United States, 56303
        • Recruiting
        • Coborn Cancer Center at Saint Cloud Hospital
        • Contact:
        • Principal Investigator:
          • Donald J. Jurgens
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Park Nicollet Clinic - Saint Louis Park
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Regions Hospital
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Saint Paul, Minnesota, United States, 55102
        • Recruiting
        • United Hospital
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 601-815-6700
        • Principal Investigator:
          • John C. Henegan
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Saint Francis Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 573-334-2230
          • Email: sfmc@sfmc.net
      • City of Saint Peters, Missouri, United States, 63376
        • Recruiting
        • Siteman Cancer Center at Saint Peters Hospital
        • Contact:
        • Principal Investigator:
          • Melissa A. Reimers
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • MU Health - University Hospital/Ellis Fischel Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 573-882-7440
        • Principal Investigator:
          • Mark R. Wakefield
      • Creve Coeur, Missouri, United States, 63141
        • Recruiting
        • Siteman Cancer Center at West County Hospital
        • Contact:
        • Principal Investigator:
          • Melissa A. Reimers
      • Farmington, Missouri, United States, 63640
        • Recruiting
        • Parkland Health Center - Farmington
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Jefferson City, Missouri, United States, 65109
        • Active, not recruiting
        • MU Health Care Goldschmidt Cancer Center
      • Kansas City, Missouri, United States, 64154
        • Recruiting
        • University of Kansas Cancer Center - North
        • Principal Investigator:
          • Saqib Abbasi
        • Contact:
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • University Health Truman Medical Center
        • Principal Investigator:
          • Saqib Abbasi
        • Contact:
          • Site Public Contact
          • Phone Number: 816-404-4375
      • Kansas City, Missouri, United States, 64128
        • Suspended
        • Kansas City Veterans Affairs Medical Center
      • Kansas City, Missouri, United States, 64116
        • Recruiting
        • University of Kansas Cancer Center - Briarcliff
        • Principal Investigator:
          • Saqib Abbasi
        • Contact:
          • Site Public Contact
          • Phone Number: 913-588-3671
      • Lee's Summit, Missouri, United States, 64064
        • Recruiting
        • University of Kansas Cancer Center - Lee's Summit
        • Principal Investigator:
          • Saqib Abbasi
        • Contact:
      • North Kansas City, Missouri, United States, 64116
        • Suspended
        • University of Kansas Cancer Center at North Kansas City Hospital
      • Sainte Genevieve, Missouri, United States, 63670
        • Recruiting
        • Sainte Genevieve County Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Springfield, Missouri, United States, 65804
        • Recruiting
        • Mercy Hospital Springfield
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Melissa A. Reimers
      • St Louis, Missouri, United States, 63128
        • Recruiting
        • Mercy Hospital South
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
      • St Louis, Missouri, United States, 63129
        • Recruiting
        • Siteman Cancer Center-South County
        • Contact:
        • Principal Investigator:
          • Melissa A. Reimers
      • St Louis, Missouri, United States, 63136
        • Recruiting
        • Siteman Cancer Center at Christian Hospital
        • Contact:
        • Principal Investigator:
          • Melissa A. Reimers
      • St Louis, Missouri, United States, 63131
        • Recruiting
        • Missouri Baptist Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • St Louis, Missouri, United States, 63125
        • Recruiting
        • Veteran's Affairs Medical Center - Saint Louis
        • Contact:
        • Principal Investigator:
          • Eric M. Knoche
      • Sullivan, Missouri, United States, 63080
        • Recruiting
        • Missouri Baptist Sullivan Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Sunset Hills, Missouri, United States, 63127
        • Recruiting
        • BJC Outpatient Center at Sunset Hills
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
    • Montana
      • Anaconda, Montana, United States, 59711
        • Recruiting
        • Community Hospital of Anaconda
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Billings, Montana, United States, 59101
        • Recruiting
        • Billings Clinic Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Bozeman, Montana, United States, 59715
        • Recruiting
        • Bozeman Health Deaconess Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Benefis Sletten Cancer Institute
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Kalispell, Montana, United States, 59901
        • Recruiting
        • Logan Health Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Community Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • Recruiting
        • Nebraska Medicine-Bellevue
        • Contact:
        • Principal Investigator:
          • Harshraj Leuva
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Harshraj Leuva
      • Omaha, Nebraska, United States, 68118
        • Recruiting
        • Nebraska Medicine-Village Pointe
        • Contact:
          • Site Public Contact
          • Phone Number: 402-559-5600
        • Principal Investigator:
          • Harshraj Leuva
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • OptumCare Cancer Care at Charleston
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89183
        • Recruiting
        • OptumCare Cancer Care at Fort Apache
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
    • New Hampshire
      • Concord, New Hampshire, United States, 03301
        • Active, not recruiting
        • New Hampshire Oncology Hematology PA-Concord
      • Manchester, New Hampshire, United States, 03103
        • Active, not recruiting
        • Solinsky Center for Cancer Care
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • David H. Aggen
      • Cherry Hill, New Jersey, United States, 08002
        • Recruiting
        • Jefferson Cherry Hill Hospital
        • Contact:
        • Principal Investigator:
          • Patrick Mille
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Principal Investigator:
          • Robert S. Alter
        • Contact:
          • Site Public Contact
          • Phone Number: 551-996-2897
      • Jersey City, New Jersey, United States, 07302
        • Recruiting
        • Jersey City Medical Center
        • Contact:
        • Principal Investigator:
          • Biren Saraiya
      • Lakewood, New Jersey, United States, 08701
        • Recruiting
        • Monmouth Medical Center Southern Campus
        • Contact:
        • Principal Investigator:
          • Biren Saraiya
      • Livingston, New Jersey, United States, 07039
        • Recruiting
        • Saint Barnabas Medical Center
        • Contact:
        • Principal Investigator:
          • Biren Saraiya
      • Long Branch, New Jersey, United States, 07740
        • Recruiting
        • Monmouth Medical Center
        • Contact:
        • Principal Investigator:
          • Biren Saraiya
      • Manahawkin, New Jersey, United States, 08050
        • Recruiting
        • Southern Ocean County Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 609-978-3429
        • Principal Investigator:
          • Evan C. Naylor
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • David H. Aggen
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • David H. Aggen
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Contact:
          • Site Public Contact
          • Phone Number: 732-235-7356
        • Principal Investigator:
          • Biren Saraiya
      • Sewell, New Jersey, United States, 08080
        • Recruiting
        • Sidney Kimmel Cancer Center Washington Township
        • Contact:
        • Principal Investigator:
          • Patrick Mille
      • Somerville, New Jersey, United States, 08876
        • Recruiting
        • Robert Wood Johnson University Hospital Somerset
        • Principal Investigator:
          • Biren Saraiya
        • Contact:
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • Community Medical Center
        • Principal Investigator:
          • Biren Saraiya
        • Contact:
    • New Mexico
      • Albuquerque, New Mexico, United States, 87110
        • Recruiting
        • Presbyterian Kaseman Hospital
        • Contact:
        • Principal Investigator:
          • Amy C. Tarnower
      • Albuquerque, New Mexico, United States, 87106
        • Suspended
        • University of New Mexico Cancer Center
      • Rio Rancho, New Mexico, United States, 87124
        • Recruiting
        • Presbyterian Rust Medical Center/Jorgensen Cancer Center
        • Contact:
        • Principal Investigator:
          • Amy C. Tarnower
    • New York
      • Brooklyn, New York, United States, 11219
        • Recruiting
        • Maimonides Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 718-765-2500
        • Principal Investigator:
          • Abhigna Kodali
      • Buffalo, New York, United States, 14263
        • Active, not recruiting
        • Roswell Park Cancer Institute
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Commack
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • David H. Aggen
      • Flushing, New York, United States, 11355
        • Recruiting
        • The New York Hospital Medical Center of Queens
        • Principal Investigator:
          • Rohit Jain
        • Contact:
      • Glens Falls, New York, United States, 12801
        • Recruiting
        • Glens Falls Hospital
        • Principal Investigator:
          • Steven Ades
        • Contact:
          • Site Public Contact
          • Phone Number: 518-926-6700
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • David H. Aggen
      • Mineola, New York, United States, 11501
        • Suspended
        • NYU Langone Hospital - Long Island
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • David H. Aggen
      • New York, New York, United States, 10011
        • Recruiting
        • Mount Sinai Chelsea
        • Contact:
          • Site Public Contact
          • Phone Number: 212-824-7309
          • Email: CCTO@mssm.edu
        • Principal Investigator:
          • Matthew D. Galsky
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 212-824-7309
          • Email: CCTO@mssm.edu
        • Principal Investigator:
          • Matthew D. Galsky
      • New York, New York, United States, 10065
        • Recruiting
        • NYP/Weill Cornell Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 212-746-1848
        • Principal Investigator:
          • Cora N. Sternberg
      • New York, New York, United States, 10016
        • Suspended
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Contact:
          • Site Public Contact
          • Phone Number: 585-275-5830
        • Principal Investigator:
          • Brendan J. Guercio
      • Rochester, New York, United States, 14621
        • Recruiting
        • Rochester General Hospital
        • Contact:
        • Principal Investigator:
          • Maria M. Sbenghe
      • Rochester, New York, United States, 14626
        • Recruiting
        • Unity Park Ridge Campus
        • Contact:
        • Principal Investigator:
          • Maria M. Sbenghe
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-862-2215
        • Principal Investigator:
          • Judy Huang
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center-Einstein Campus
        • Contact:
        • Principal Investigator:
          • Benjamin A. Gartrell
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • David H. Aggen
      • Webster, New York, United States, 14580
    • North Carolina
      • Albemarle, North Carolina, United States, 28002
        • Recruiting
        • Atrium Health Stanly/LCI-Albemarle
        • Principal Investigator:
          • Landon C. Brown
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Cary, North Carolina, United States, 27518
        • Recruiting
        • Duke Cancer Center Cary
        • Contact:
        • Principal Investigator:
          • Hannah D. McManus
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Lineberger Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Matthew I. Milowsky
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Carolinas Medical Center/Levine Cancer Institute
        • Principal Investigator:
          • Landon C. Brown
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Charlotte, North Carolina, United States, 28210
        • Recruiting
        • Atrium Health Pineville/LCI-Pineville
        • Principal Investigator:
          • Landon C. Brown
        • Contact:
          • Site Public Contact
          • Phone Number: 980-442-2000
      • Charlotte, North Carolina, United States, 28211
        • Recruiting
        • Levine Cancer Institute-SouthPark
        • Principal Investigator:
          • Landon C. Brown
        • Contact:
          • Site Public Contact
          • Phone Number: 980-442-2000
      • Charlotte, North Carolina, United States, 28262
        • Recruiting
        • Atrium Health University City/LCI-University
        • Principal Investigator:
          • Landon C. Brown
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Charlotte, North Carolina, United States, 28277
        • Recruiting
        • Levine Cancer Institute-Ballantyne
        • Principal Investigator:
          • Landon C. Brown
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Clemmons, North Carolina, United States, 27012
        • Recruiting
        • Wake Forest University at Clemmons
        • Contact:
          • Site Public Contact
          • Phone Number: 888-716-9259
        • Principal Investigator:
          • Michael McCormack
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 888-275-3853
        • Principal Investigator:
          • Hannah D. McManus
      • Durham, North Carolina, United States, 27713
        • Recruiting
        • Duke Cancer Center Southpoint
        • Contact:
        • Principal Investigator:
          • Hannah D. McManus
      • Forest City, North Carolina, United States, 28043
        • Recruiting
        • Levine Cancer Institute - Rutherford
        • Principal Investigator:
          • Landon C. Brown
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Gastonia, North Carolina, United States, 28054
        • Recruiting
        • Levine Cancer Institute-Gaston
        • Principal Investigator:
          • Landon C. Brown
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Levine Cancer Institute - Huntersville
        • Principal Investigator:
          • Landon C. Brown
        • Contact:
          • Site Public Contact
          • Phone Number: 980-442-2000
      • Lincolnton, North Carolina, United States, 28092
        • Recruiting
        • Atrium Health Lincoln/LCI-Lincolnton
        • Principal Investigator:
          • Landon C. Brown
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Matthews, North Carolina, United States, 28104
        • Recruiting
        • Levine Cancer Institute - Union West
        • Contact:
          • Site Public Contact
          • Phone Number: 980-442-0600
        • Principal Investigator:
          • Landon C. Brown
      • Monroe, North Carolina, United States, 28112
        • Recruiting
        • Atrium Health Union/LCI-Union
        • Principal Investigator:
          • Landon C. Brown
        • Contact:
          • Site Public Contact
          • Phone Number: 980-442-2000
      • Pinehurst, North Carolina, United States, 28374
        • Recruiting
        • FirstHealth of the Carolinas-Moore Regional Hospital
        • Contact:
        • Principal Investigator:
          • Charles S. Kuzma
      • Raleigh, North Carolina, United States, 27609
        • Recruiting
        • Duke Cancer Center Raleigh
        • Contact:
        • Principal Investigator:
          • Hannah D. McManus
      • Shelby, North Carolina, United States, 28150
        • Recruiting
        • Atrium Health Cleveland/LCI-Cleveland
        • Principal Investigator:
          • Landon C. Brown
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:
          • Site Public Contact
          • Phone Number: 336-713-6771
        • Principal Investigator:
          • Michael McCormack
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
      • Fargo, North Dakota, United States, 58122
      • Fargo, North Dakota, United States, 58122
    • Ohio
      • Athens, Ohio, United States, 45701
        • Recruiting
        • OhioHealth O'Bleness Hospital
        • Contact:
        • Principal Investigator:
          • Arvinder S. Bhinder
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Cancer Center-UC Medical Center
        • Contact:
        • Principal Investigator:
          • Robert A. Franklin
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • Columbus Oncology and Hematology Associates Inc
        • Contact:
        • Principal Investigator:
          • Arvinder S. Bhinder
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • Riverside Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Arvinder S. Bhinder
      • Columbus, Ohio, United States, 43215
        • Recruiting
        • Grant Medical Center
        • Contact:
        • Principal Investigator:
          • Arvinder S. Bhinder
      • Columbus, Ohio, United States, 43228
        • Recruiting
        • Doctors Hospital
        • Contact:
        • Principal Investigator:
          • Arvinder S. Bhinder
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Lingbin Meng
      • Delaware, Ohio, United States, 43015
        • Recruiting
        • Delaware Health Center-Grady Cancer Center
        • Contact:
        • Principal Investigator:
          • Arvinder S. Bhinder
      • Delaware, Ohio, United States, 43015
        • Recruiting
        • Grady Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Arvinder S. Bhinder
      • Dublin, Ohio, United States, 43016
        • Recruiting
        • Columbus Oncology and Hematology Associates
        • Contact:
        • Principal Investigator:
          • Arvinder S. Bhinder
      • Dublin, Ohio, United States, 43016
        • Recruiting
        • Dublin Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Arvinder S. Bhinder
      • Mansfield, Ohio, United States, 44903
        • Recruiting
        • OhioHealth Mansfield Hospital
        • Contact:
        • Principal Investigator:
          • Arvinder S. Bhinder
      • Marion, Ohio, United States, 43302
        • Recruiting
        • OhioHealth Marion General Hospital
        • Contact:
        • Principal Investigator:
          • Arvinder S. Bhinder
      • Pickerington, Ohio, United States, 43147
        • Recruiting
        • OhioHealth Pickerington Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Arvinder S. Bhinder
      • Sylvania, Ohio, United States, 43560
        • Recruiting
        • ProMedica Flower Hospital
        • Contact:
        • Principal Investigator:
          • Jeffrey H. Muler
      • West Chester, Ohio, United States, 45069
        • Recruiting
        • University of Cincinnati Cancer Center-West Chester
        • Contact:
        • Principal Investigator:
          • Robert A. Franklin
      • Westerville, Ohio, United States, 43082
        • Recruiting
        • OhioHealth Westerville Medical Campus/Westerville Cancer Center
        • Contact:
        • Principal Investigator:
          • Arvinder S. Bhinder
    • Oklahoma
      • Lawton, Oklahoma, United States, 73505
        • Recruiting
        • Cancer Centers of Southwest Oklahoma Research
        • Contact:
          • Site Public Contact
          • Phone Number: 877-231-4440
        • Principal Investigator:
          • Adanma Anji Ayanambakkam Attanathi
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Adanma Anji Ayanambakkam Attanathi
      • Tulsa, Oklahoma, United States, 74146
        • Active, not recruiting
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
    • Oregon
      • Ontario, Oregon, United States, 97914
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Ontario
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Oregon City, Oregon, United States, 97045
        • Recruiting
        • Providence Willamette Falls Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
        • Principal Investigator:
          • Ronald Ng
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Saint Vincent Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Lehigh Valley Hospital-Cedar Crest
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Altoona, Pennsylvania, United States, 16601
        • Recruiting
        • UPMC Altoona
        • Contact:
        • Principal Investigator:
          • Leonard J. Appleman
      • Beaver, Pennsylvania, United States, 15009
        • Recruiting
        • UPMC-Heritage Valley Health System Beaver
        • Contact:
        • Principal Investigator:
          • Leonard J. Appleman
      • Bethlehem, Pennsylvania, United States, 18017
        • Recruiting
        • Lehigh Valley Hospital - Muhlenberg
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • East Stroudsburg, Pennsylvania, United States, 18301
        • Recruiting
        • Pocono Medical Center
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Erie, Pennsylvania, United States, 16505
        • Recruiting
        • UPMC Hillman Cancer Center Erie
        • Principal Investigator:
          • Leonard J. Appleman
        • Contact:
      • Greensburg, Pennsylvania, United States, 15601
        • Recruiting
        • UPMC Cancer Centers - Arnold Palmer Pavilion
        • Contact:
          • Site Public Contact
          • Phone Number: 724-838-1900
        • Principal Investigator:
          • Leonard J. Appleman
      • Harrisburg, Pennsylvania, United States, 17109
        • Recruiting
        • UPMC Pinnacle Cancer Center/Community Osteopathic Campus
        • Contact:
        • Principal Investigator:
          • Leonard J. Appleman
      • Lancaster, Pennsylvania, United States, 17601
        • Active, not recruiting
        • Lancaster General Ann B Barshinger Cancer Institute
      • Mechanicsburg, Pennsylvania, United States, 17050
        • Recruiting
        • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
        • Contact:
        • Principal Investigator:
          • Leonard J. Appleman
      • Monroeville, Pennsylvania, United States, 15146
        • Recruiting
        • UPMC Hillman Cancer Center - Monroeville
        • Principal Investigator:
          • Leonard J. Appleman
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Hospital
        • Contact:
        • Principal Investigator:
          • Patrick Mille
      • Philadelphia, Pennsylvania, United States, 19114
        • Recruiting
        • Jefferson Torresdale Hospital
        • Contact:
        • Principal Investigator:
          • Patrick Mille
      • Philadelphia, Pennsylvania, United States, 19104
        • Active, not recruiting
        • University of Pennsylvania/Abramson Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburgh Cancer Institute (UPCI)
        • Contact:
          • Site Public Contact
          • Phone Number: 412-647-8073
        • Principal Investigator:
          • Leonard J. Appleman
      • Pittsburgh, Pennsylvania, United States, 15215
        • Recruiting
        • UPMC-Saint Margaret
        • Contact:
          • Site Public Contact
          • Phone Number: 412-784-4900
        • Principal Investigator:
          • Leonard J. Appleman
      • Pittsburgh, Pennsylvania, United States, 15237
        • Recruiting
        • UPMC-Passavant Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 412-367-6454
        • Principal Investigator:
          • Leonard J. Appleman
      • Pittsburgh, Pennsylvania, United States, 15243
        • Recruiting
        • UPMC-Saint Clair Hospital Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 412-502-3920
        • Principal Investigator:
          • Leonard J. Appleman
      • West Reading, Pennsylvania, United States, 19611
        • Recruiting
        • Reading Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 610-988-9323
        • Principal Investigator:
          • Terrence P. Cescon
      • Willow Grove, Pennsylvania, United States, 19090
        • Recruiting
        • Asplundh Cancer Pavilion
        • Contact:
        • Principal Investigator:
          • Patrick Mille
    • Rhode Island
      • Westerly, Rhode Island, United States, 02891
        • Recruiting
        • Smilow Cancer Hospital Care Center - Westerly
        • Contact:
        • Principal Investigator:
          • Joseph W. Kim
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Recruiting
        • AnMed Health Cancer Center
        • Contact:
        • Principal Investigator:
          • John E. Doster
      • Boiling Springs, South Carolina, United States, 29316
        • Recruiting
        • Prisma Health Cancer Institute - Spartanburg
        • Principal Investigator:
          • Ki Y. Chung
        • Contact:
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Theodore S. Gourdin
      • Easley, South Carolina, United States, 29640
        • Recruiting
        • Prisma Health Cancer Institute - Easley
        • Principal Investigator:
          • Ki Y. Chung
        • Contact:
      • Gaffney, South Carolina, United States, 29341
        • Recruiting
        • Gibbs Cancer Center-Gaffney
        • Contact:
        • Principal Investigator:
          • Michael Humeniuk
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health Cancer Institute - Faris
        • Principal Investigator:
          • Ki Y. Chung
        • Contact:
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health Cancer Institute - Butternut
        • Principal Investigator:
          • Ki Y. Chung
        • Contact:
      • Greenville, South Carolina, United States, 29615
        • Recruiting
        • Prisma Health Cancer Institute - Eastside
        • Principal Investigator:
          • Ki Y. Chung
        • Contact:
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health Greenville Memorial Hospital
        • Principal Investigator:
          • Ki Y. Chung
        • Contact:
      • Greer, South Carolina, United States, 29650
        • Recruiting
        • Prisma Health Cancer Institute - Greer
        • Principal Investigator:
          • Ki Y. Chung
        • Contact:
      • Greer, South Carolina, United States, 29651
        • Recruiting
        • Gibbs Cancer Center-Pelham
        • Contact:
        • Principal Investigator:
          • Michael Humeniuk
      • Rock Hill, South Carolina, United States, 29732
        • Recruiting
        • Levine Cancer Institute-Rock Hill
        • Principal Investigator:
          • Landon C. Brown
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Seneca, South Carolina, United States, 29672
        • Recruiting
        • Prisma Health Cancer Institute - Seneca
        • Principal Investigator:
          • Ki Y. Chung
        • Contact:
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Spartanburg Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Humeniuk
      • Union, South Carolina, United States, 29379
        • Recruiting
        • SMC Center for Hematology Oncology Union
        • Contact:
        • Principal Investigator:
          • Michael Humeniuk
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
      • Sioux Falls, South Dakota, United States, 57117-5134
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Active, not recruiting
        • The West Clinic - Wolf River
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University/Ingram Cancer Center
        • Principal Investigator:
          • Kerry R. Schaffer
        • Contact:
          • Site Public Contact
          • Phone Number: 800-811-8480
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Principal Investigator:
          • Tian Zhang
        • Contact:
      • Dallas, Texas, United States, 75237
        • Recruiting
        • UT Southwestern Simmons Cancer Center - RedBird
        • Principal Investigator:
          • Tian Zhang
        • Contact:
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • UT Southwestern/Simmons Cancer Center-Fort Worth
        • Principal Investigator:
          • Tian Zhang
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 713-798-1354
          • Email: burton@bcm.edu
        • Principal Investigator:
          • Aihua E. Yen
      • Houston, Texas, United States, 77030
        • Recruiting
        • Ben Taub General Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 713-873-2000
        • Principal Investigator:
          • Aihua E. Yen
      • Houston, Texas, United States, 77026-1967
        • Recruiting
        • Lyndon Baines Johnson General Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 713-566-5000
        • Principal Investigator:
          • Debanjan Pain
      • Houston, Texas, United States, 77030
        • Recruiting
        • Michael E DeBakey VA Medical Center
        • Principal Investigator:
          • Aihua E. Yen
        • Contact:
          • Site Public Contact
          • Phone Number: 800-553-2278
      • Richardson, Texas, United States, 75080
        • Recruiting
        • UT Southwestern Clinical Center at Richardson/Plano
        • Principal Investigator:
          • Tian Zhang
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute/University of Utah
        • Contact:
        • Principal Investigator:
          • Bogdana Schmidt
    • Vermont
      • Berlin Corners, Vermont, United States, 05602
        • Recruiting
        • Central Vermont Medical Center/National Life Cancer Treatment
        • Principal Investigator:
          • Steven Ades
        • Contact:
          • Site Public Contact
          • Phone Number: 802-225-5400
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • University of Vermont Medical Center
        • Principal Investigator:
          • Steven Ades
        • Contact:
          • Site Public Contact
          • Phone Number: 802-656-4101
          • Email: rpo@uvm.edu
      • Burlington, Vermont, United States, 05405
        • Recruiting
        • University of Vermont and State Agricultural College
        • Principal Investigator:
          • Steven Ades
        • Contact:
          • Site Public Contact
          • Phone Number: 802-656-8990
          • Email: rpo@uvm.edu
    • Virginia
      • Charlottesville, Virginia, United States, 22908
      • Mechanicsville, Virginia, United States, 23116
        • Recruiting
        • Bon Secours Memorial Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Joseph D. Pennington
      • Midlothian, Virginia, United States, 23114
        • Recruiting
        • Bon Secours Saint Francis Medical Center
        • Contact:
        • Principal Investigator:
          • Joseph D. Pennington
      • Richmond, Virginia, United States, 23235
        • Recruiting
        • VCU Massey Cancer Center at Stony Point
        • Contact:
        • Principal Investigator:
          • John Melson
      • Richmond, Virginia, United States, 23226
        • Recruiting
        • Bon Secours Saint Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Joseph D. Pennington
      • Richmond, Virginia, United States, 23223
        • Recruiting
        • Bon Secours Richmond Community Hospital
        • Contact:
        • Principal Investigator:
          • Joseph D. Pennington
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • VCU Massey Comprehensive Cancer Center
        • Principal Investigator:
          • John Melson
        • Contact:
      • South Hill, Virginia, United States, 23970
        • Recruiting
        • VCU Community Memorial Health Center
        • Contact:
        • Principal Investigator:
          • John Melson
    • Washington
      • Seattle, Washington, United States, 98101
        • Recruiting
        • Virginia Mason Medical Center
        • Principal Investigator:
          • Huong T. Pham
        • Contact:
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Recruiting
        • West Virginia University Charleston Division
        • Contact:
          • Site Public Contact
          • Phone Number: 304-388-9944
        • Principal Investigator:
          • Kok Hoe Chan
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University Healthcare
        • Contact:
        • Principal Investigator:
          • Raheel S. Siddiqui
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • Recruiting
        • ThedaCare Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Joyce Philip
      • Cudahy, Wisconsin, United States, 53110
        • Recruiting
        • Aurora Saint Luke's South Shore
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Eau Claire, Wisconsin, United States, 54701
      • Grafton, Wisconsin, United States, 53024
        • Recruiting
        • Aurora Cancer Care-Grafton
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Green Bay, Wisconsin, United States, 54311
        • Recruiting
        • Aurora BayCare Medical Center
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Green Bay, Wisconsin, United States, 54301
        • Recruiting
        • Saint Vincent Hospital Cancer Center Green Bay
        • Principal Investigator:
          • Anthony J. Jaslowski
        • Contact:
      • Green Bay, Wisconsin, United States, 54303
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Saint Mary's
        • Principal Investigator:
          • Anthony J. Jaslowski
        • Contact:
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Carbone Cancer Center - University Hospital
        • Principal Investigator:
          • Christos Kyriakopoulos
        • Contact:
      • Madison, Wisconsin, United States, 53718
        • Recruiting
        • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
        • Principal Investigator:
          • Christos Kyriakopoulos
        • Contact:
      • Marinette, Wisconsin, United States, 54143
        • Recruiting
        • Aurora Bay Area Medical Group-Marinette
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Marshfield, Wisconsin, United States, 54449
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Aurora Saint Luke's Medical Center
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Principal Investigator:
          • Kathryn A. Bylow
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-3666
      • Milwaukee, Wisconsin, United States, 53233
        • Recruiting
        • Aurora Sinai Medical Center
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Mukwonago, Wisconsin, United States, 53149
        • Recruiting
        • ProHealth D N Greenwald Center
        • Contact:
        • Principal Investigator:
          • Timothy R. Wassenaar
      • Oconomowoc, Wisconsin, United States, 53066
        • Recruiting
        • ProHealth Oconomowoc Memorial Hospital
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:
          • Site Public Contact
          • Phone Number: 262-928-7878
      • Oconto Falls, Wisconsin, United States, 54154
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Oconto Falls
        • Principal Investigator:
          • Anthony J. Jaslowski
        • Contact:
      • Oshkosh, Wisconsin, United States, 54904
        • Recruiting
        • Vince Lombardi Cancer Clinic - Oshkosh
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Sheboygan, Wisconsin, United States, 53081
        • Recruiting
        • Vince Lombardi Cancer Clinic-Sheboygan
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Sheboygan, Wisconsin, United States, 53081
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Sheboygan
        • Principal Investigator:
          • Anthony J. Jaslowski
        • Contact:
      • Stevens Point, Wisconsin, United States, 54482
      • Sturgeon Bay, Wisconsin, United States, 54235-1495
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
        • Principal Investigator:
          • Anthony J. Jaslowski
        • Contact:
      • Summit, Wisconsin, United States, 53066
        • Recruiting
        • Aurora Medical Center in Summit
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Two Rivers, Wisconsin, United States, 54241
        • Recruiting
        • Vince Lombardi Cancer Clinic-Two Rivers
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Waukesha, Wisconsin, United States, 53188
        • Recruiting
        • ProHealth Waukesha Memorial Hospital
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:
          • Site Public Contact
          • Phone Number: 262-928-7632
      • Waukesha, Wisconsin, United States, 53188
        • Recruiting
        • UW Cancer Center at ProHealth Care
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:
      • Wauwatosa, Wisconsin, United States, 53226
        • Recruiting
        • Aurora Cancer Care-Milwaukee West
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • West Allis, Wisconsin, United States, 53227
        • Recruiting
        • Aurora West Allis Medical Center
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Weston, Wisconsin, United States, 54476

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • PRE-REGISTRATION (STEP 0): Histologically confirmed muscle-invasive urothelial carcinoma of the urethra, bladder, ureter or renal pelvis
  • PRE-REGISTRATION (STEP 0): Variant histology, including neuroendocrine differentiation, sarcomatoid, micropapillary, glandular, trophoblastic, Mullerian, is allowed if urothelial cancer is predominant histology (any amount of squamous differentiation is allowed provided the tumor is not a pure squamous cell cancer)
  • PRE-REGISTRATION (STEP 0): Radical surgery (cystectomy with lymph node dissection or nephroureterectomy or ureterectomy) must be ≥ 3 weeks and ≤ 12 weeks (central Signatera pathway) or ≤ 16 weeks (commercial Signatera pathwary) prior to pre-registration. Patients who have had a partial cystectomy as definitive therapy are not eligible
  • PRE-REGISTRATION (STEP 0): Patients who have had a partial cystectomy as definitive therapy are not eligible
  • PRE-REGISTRATION (STEP 0): No gross cancer at the surgical margins. Microscopic invasive urothelial carcinoma at the surgical margins (i.e., "positive margins") are allowed. Carcinoma in situ (CIS) at margins is considered negative margins
  • PRE-REGISTRATION (STEP 0): No evidence of residual cancer or metastasis after radical cystectomy or nephroureterectomy or ureterectomy (imaging is not required prior to pre-registration but is required prior to registration)

  • PRE-REGISTRATION (STEP 0): Have undergone a radical cystectomy nephroureterectomy, or ureterectomy with pathological evidence of urothelial carcinoma at high risk of recurrence as described in one of the two scenarios below (i or ii). The 7th edition of American Joint Committee on Cancer (AJCC) staging will be utilized.:

    • (i) Patients who have not received neoadjuvant systemic therapy: pT4N0 or pTanyN+ on radical surgery pathology specimen (i.e., cystectomy, nephroureterectomy, or ureterectomy) and are not eligible for adjuvant cisplatin chemotherapy

      • (i) Patients ineligible for cisplatin due to at least one of the following criteria and reason for ineligibility should be documented:

        • (i) Creatinine Clearance (using Cockcroft-Gault): < 60 mL/min
        • (i) Common Terminology Criteria for Adverse Events (CTCAE) version 5, grade >= 2 audiometric hearing loss
        • (i) CTCAE version 5, grade >= 2 or above peripheral neuropathy
        • New York Heart Association Class III heart failure
        • (i) Eastern Cooperative Oncology Group (ECOG) performance status = 2

      • (i) Patients who are eligible for adjuvant cisplatin may be candidates if they refuse adjuvant cisplatin-based chemotherapy, despite being informed by the investigator about the treatment options. The patient's refusal must be documented.

        • (i) Patients with pT2N0 urothelial cancer on radical surgery specimen (without prior neoadjuvant systemic therapy) with ctDNA(+) Signatera results are eligible only if the result was obtained via commercial testing (central testing is not permitted for this population) (Note: this is distinct from patients with ypT2N0 who are eligible based on ii).
    • (ii) Patients who received neoadjuvant systemic therapy: ypT2-T4N0 or Nx or ypTanyN+ on radical surgery (i.e., cystectomy. , nephroureterectomy, or ureterectomy) pathology specimen. Neoadjuvant systemic therapy may have included cisplatin-based chemotherapy, cisplatin-based chemotherapy plus PD-1/PD-L1 blockade, or enfortumab vedotin plus PD-1/PD-L1 blockade

  • PRE-REGISTRATION (STEP 0): Patients are required to meet criteria for one of two criteria:

    • 1) Commercial Signatera pathway:

      • Available commercial Signatera testing result (i.e., ctDNA+ or ctDNA-) from blood sample obtained ≥ 3 weeks and ≤ 16 weeks from time of radical surgery performed as part of standard care

        • Sites are required to verify that the commercial Signatera report demonstrates a complete 16 target assay design and that the test was designed on exome. This verification is conducted at the site level during the eligibility review. OR

    • Central Signatera pathway:

      • Pre-registration samples are to be submitted after pre-registration, at ≥ 3 weeks but ≤ 12 weeks from the time of radical surgery

        • Ineligible patients for the commercial pathway must use the central Signatera pathway and provide tumor tissue as part of the A032103 study
        • For patients who have not had neoadjuvant chemotherapy, tumor tissue is preferred from the radical surgery specimen
        • For patients who have had neoadjuvant therapy, tissue is preferred from the pre-chemotherapy specimen diagnosing muscle-invasive disease (e.g., transurethral resection of bladder tumor specimen)
  • PRE-REGISTRATION (STEP 0): Age >= 18 years
  • PRE-REGISTRATION (STEP 0): ECOG performance status 0-2
  • PRE-REGISTRATION (STEP 0): Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects
  • PRE-REGISTRATION (STEP 0): No postoperative adjuvant systemic therapy after radical surgery
  • PRE-REGISTRATION (STEP 0): No adjuvant radiation after radical surgery
  • PRE-REGISTRATION (STEP 0): No treatment with any other type of investigational agent =< 4 weeks before pre-registration
  • PRE-REGISTRATION (STEP 0): No previous treatment with LAG-3 blockade therapy
  • PRE-REGISTRATION (STEP 0): Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • PRE-REGISTRATION (STEP 0): Absolute neutrophil count (ANC) >= 1,200/mm^3
  • PRE-REGISTRATION (STEP 0): Platelet count >= 100,000/mm^3
  • PRE-REGISTRATION (STEP 0): Hemoglobin >= 8 g/dL
  • PRE-REGISTRATION (STEP 0): Creatinine =< 1.5 x upper limit of normal (ULN) or calculated (calc.) creatinine clearance > 30 mL/min (using either Cockcroft-Gault formula or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
  • PRE-REGISTRATION (STEP 0): Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x ULN
  • PRE-REGISTRATION (STEP 0): Total bilirubin =< 1.5 x upper limit of normal (ULN) (except in patients with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
  • PRE-REGISTRATION (STEP 0): For women of childbearing potential only: A negative urine or serum pregnancy test done =< 14 days prior to pre-registration is required
  • PRE-REGISTRATION (STEP 0): Not currently requiring hemodialysis
  • PRE-REGISTRATION (STEP 0): No current or prior history of myocarditis
  • PRE-REGISTRATION (STEP 0): No history of a grade ≥ 3 immune related adverse event with prior PD-1/PD-L1 blockade in the neoadjuvant setting
  • PRE-REGISTRATION (STEP 0): No active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens- Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease.
  • PRE-REGISTRATION (STEP 0): Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible.
  • PRE-REGISTRATION (STEP 0): Patients with rheumatoid arthritis and other arthropathies, Sjögren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible.
  • PRE-REGISTRATION (STEP 0): No current pneumonitis or prior history of non-infectious pneumonitis that required steroids within the previous 5 years.
  • PRE-REGISTRATION (STEP 0): No known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected).
  • PRE-REGISTRATION (STEP 0): For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • PRE-REGISTRATION (STEP 0): Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible.
  • PRE-REGISTRATION (STEP 0): No concurrent antineoplastic therapy including anti-hormonal treatments used for cancer therapy (e.g., leuprolide, antiandrogens)
  • PRE-REGISTRATION (STEP 0): No current immunosuppressive agents (except for corticosteroids as described below).
  • PRE-REGISTRATION (STEP 0): No condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of pre-registration (with the exception of steroid pre-medications for contrast allergies). Inhaled or topical steroids and adrenal replacement doses < 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • REGISTRATION (STEP 1): Patient must have had radical cystectomy and lymph node dissection or nephroureterectomy or ureterectomy =< 18 weeks prior to registration.

  • REGISTRATION (STEP 1): Must have evaluable ctDNA Signatera assay result (i.e., ctDNA+ or ctDNA-) based on either:

    • Commercial Signatera result OR
    • Central Signatera testing result (i.e. testing that was performed as part of A032103.)
  • REGISTRATION (STEP 1): All patients must have confirmed disease-free status defined as no measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or definitive non-measurable radiographic metastatic disease, within 60 days prior to registration. Patients with equivocal lymph nodes less than 15 mm in short axis, or < 10 mm in long axis for non-lymph node lesions, not considered by the investigator to represent malignant disease will be eligible. Attempts should be made to resolve the etiology of equivocal lesions with complementary imaging (e.g., PET scan) or biopsy.
  • REGISTRATION (STEP 1): No major surgery =< 3 weeks before registration.
  • REGISTRATION (STEP 1): No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette- Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist [registered trademark]) are live attenuated vaccines and are not allowed. Coronavirus disease 2019 (COVID-19) vaccines are not live vaccines and are allowed
  • REGISTRATION (STEP 1): No change since Step 0 pre-registration in clinical condition and/or laboratory tests that would impact the safety of nivolumab +/- relatlimab administration in the opinion of the treating investigator
  • REGISTRATION (STEP 1): No evidence of high grade urothelial cancer in the bladder for patients with primary urothelial cancers of the upper urinary tract

  • RE-REGISTRATION (STEP 2) COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):

    • Patient must have converted to ctDNA(+) during serial monitoring performed centrally as part of A032103

  • RE-REGISTRATION (STEP 2) COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):

    • No evidence of metastatic disease on the most recent scheduled imaging assessment as outlined in the study calendar (no repeat imaging is necessary specifically at the time of the conversion from ctDNA[-] to ctDNA[+]).

  • RE-REGISTRATION (STEP 2) COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):

    • In the opinion of the treating investigator, patient clinical condition and laboratory tests would not impact the safety of nivolumab administration in the opinion of the treating investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cohort A, Arm I (nivolumab)
Patients in Cohort A, Arm I receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI and may undergo cystoscopy throughout the trial.
Biological: Nivolumab
Given IV
Other Names:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo
  • CMAB819
  • Nivolumab Biosimilar CMAB819
  • MDX 1106
  • MDX1106
  • BMS 936558
  • ABP 206
  • Nivolumab Biosimilar ABP 206
  • BCD-263
  • Nivolumab Biosimilar BCD-263
  • BMS936558
  • ONO 4538
  • ONO4538
Other: Questionnaire Administration
Ancillary studies
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Procedure: Computed Tomography
Undergo CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
  • Diagnostic CAT Scan
  • Diagnostic CAT Scan Service Type
Procedure: Cystoscopy
Undergo cystoscopy
Other Names:
  • CS
Procedure: Biospecimen Collection
Undergo collection of tissue and blood
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Experimental: Cohort A, Arm II (nivolumab, relatlimab)
Patients in Cohort A, Arm II receive nivolumab IV over 30 minutes and relatlimab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI and may undergo cystoscopy throughout the trial.
Biological: Nivolumab
Given IV
Other Names:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo
  • CMAB819
  • Nivolumab Biosimilar CMAB819
  • MDX 1106
  • MDX1106
  • BMS 936558
  • ABP 206
  • Nivolumab Biosimilar ABP 206
  • BCD-263
  • Nivolumab Biosimilar BCD-263
  • BMS936558
  • ONO 4538
  • ONO4538
Other: Questionnaire Administration
Ancillary studies
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Procedure: Computed Tomography
Undergo CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
  • Diagnostic CAT Scan
  • Diagnostic CAT Scan Service Type
Biological: Relatlimab
Given IV
Other Names:
  • BMS-986016
  • BMS986016
  • Immunoglobulin G4, Anti-(human Lymphocyte Activation Gene-3 Protein) (Human Heavy Chain), Disulfide with Human Light Chain, Dimer
  • BMS 986016
Procedure: Cystoscopy
Undergo cystoscopy
Other Names:
  • CS
Procedure: Biospecimen Collection
Undergo collection of tissue and blood
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Active Comparator: Cohort B, Arm III (nivolumab)
Patients in Cohort B, Arm III receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI and may undergo cystoscopy throughout the trial.
Biological: Nivolumab
Given IV
Other Names:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo
  • CMAB819
  • Nivolumab Biosimilar CMAB819
  • MDX 1106
  • MDX1106
  • BMS 936558
  • ABP 206
  • Nivolumab Biosimilar ABP 206
  • BCD-263
  • Nivolumab Biosimilar BCD-263
  • BMS936558
  • ONO 4538
  • ONO4538
Other: Questionnaire Administration
Ancillary studies
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Procedure: Computed Tomography
Undergo CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
  • Diagnostic CAT Scan
  • Diagnostic CAT Scan Service Type
Procedure: Biospecimen Collection
Undergo collection of tissue and blood
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Experimental: Cohort B, Arm IV (ctDNA surveillance, nivolumab)
Patients in Cohort B, Arm IV undergo ctDNA surveillance consisting of collection of tissue and blood during screening and collection of blood only on study and during follow up. Patients who convert to ctDNA(+) during surveillance then receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI and may undergo cystoscopy throughout the trial.
Biological: Nivolumab
Given IV
Other Names:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo
  • CMAB819
  • Nivolumab Biosimilar CMAB819
  • MDX 1106
  • MDX1106
  • BMS 936558
  • ABP 206
  • Nivolumab Biosimilar ABP 206
  • BCD-263
  • Nivolumab Biosimilar BCD-263
  • BMS936558
  • ONO 4538
  • ONO4538
Other: Questionnaire Administration
Ancillary studies
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Procedure: Computed Tomography
Undergo CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
  • Diagnostic CAT Scan
  • Diagnostic CAT Scan Service Type
Procedure: Cystoscopy
Undergo cystoscopy
Other Names:
  • CS
Procedure: Biospecimen Collection
Undergo collection of tissue and blood
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Other: cfDNA or ctDNA Measurement
Undergo ctDNA surveillance
Other Names:
  • Cell-Free DNA/Circulating Tumor DNA Measurement
  • cfDNA/ctdDNA Measurement
  • cfDNA/ctDNA
  • cfDNA/ctDNA Measurement
  • Circulating Cell-Free DNA/Circulating Tumor-Derived DNA Measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS) (Cohort A Phase III)
Time Frame: From randomization until death due to any cause, assessed up to 5 years after completion of study treatment
The analysis will be performed using a stratified log-rank test that uses the specified stratification variables. An additional analysis will be perform using a stratified Cox regression model to generate the point estimate and 90% confidence interval for the hazard ratio (HR) (comparing Arm 2 to Arm 1).
From randomization until death due to any cause, assessed up to 5 years after completion of study treatment
Proportion of patients who are circulating tumor DNA negative (ctDNA[-]) (Cohort A Phase II)
Time Frame: At week 12 from treatment start date
Will be determined for each treatment arm as the number of patients who are ctDNA(-) after 12 weeks of treatment divided by the total number of patients on the treatment arm. Patients who do not have a 12-week ctDNA result will be deemed to be ctDNA(+). The comparison of the proportions of patients who are ctDNA(-) after 12 weeks of treatment between the two arms will be performed with a chi-square test.
At week 12 from treatment start date
Disease-Free Survival (DFS) (Cohort B)
Time Frame: From randomization until confirmed disease recurrence as assessed by the treating physician or death due to any cause, assessed up to 5 years after completion of study treatment
A stratified Cox model (using the randomization stratification variables will be used to generate a 90% confidence interval (CI) for the HR. If the 90% CI does not contain 1.39, Arm 4 (surveillance with ctDNA serial testing to determine whether patient is treated with nivolumab) will be deemed to be non-inferior to treating patients immediately with nivolumab.
From randomization until confirmed disease recurrence as assessed by the treating physician or death due to any cause, assessed up to 5 years after completion of study treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events (Cohort A)
Time Frame: Up to 5 years after completion of study treatment
Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Adverse events (AEs) will be summarized with frequencies and relative frequencies. The maximum grade for an AE will be recorded for each patient by treatment arm. The number (percent) of patients that experience each observed adverse event will be summarized by treatment arm. In addition, the proportion of patients that experience a grade 3+, grade 4+, and grade 5 adverse event will be summarized as the number and percent of patients by treatment arm. The primary summary will be regardless of attribution.
Up to 5 years after completion of study treatment
OS (Cohort B)
Time Frame: From randomization until death due to any cause, assessed up to 5 years after completion of study treatment
From randomization until death due to any cause, assessed up to 5 years after completion of study treatment
Cumulative incidence of ctDNA(+) conversion (Cohort B)
Time Frame: From randomization until a patient becomes ctDNA(+), assessed up to 5 years after completion of study treatment
From randomization until a patient becomes ctDNA(+), assessed up to 5 years after completion of study treatment
Lead time for ctDNA(+) conversion (Cohort B)
Time Frame: From when a patient becomes ctDNA(+) until a confirmed radiographic disease recurrence, assessed up to 5 years after completion of study treatment
From when a patient becomes ctDNA(+) until a confirmed radiographic disease recurrence, assessed up to 5 years after completion of study treatment
Incidence of adverse events (Cohort B)
Time Frame: Up to 5 years after completion of study treatment
Will be assessed using CTCAE v5.0. Adverse events will be summarized with frequencies and relative frequencies. The maximum grade for an AE will be recorded for each patient by treatment arm. The number (percent) of patients that experience each observed adverse event will be summarized by treatment arm. In addition, the proportion of patients that experience a grade 3+, grade 4+, and grade 5 adverse event will be summarized as the number and percent of patients by treatment arm. The primary summary will be regardless of attribution.
Up to 5 years after completion of study treatment
Proportion of patients who are ctDNA(-) (Cohort A Phase III) from treatment start date
Time Frame: At week 12
Will be determined for each treatment arm as the number of patients who are ctDNA(-) after 12 weeks of treatment divided by the total number of patients on the treatment arm. Patients who do not have a 12-week ctDNA result will be deemed to be ctDNA(+).
At week 12
OS (Cohort A Phase II)
Time Frame: From randomization until death due to any cause, assessed up to 5 years after completion of study treatment
If the trial does not continue to phase III, OS will be a secondary endpoint.
From randomization until death due to any cause, assessed up to 5 years after completion of study treatment
DFS (Cohort A Phase II or III)
Time Frame: From randomization until confirmed disease recurrence as assessed by the treating physician or death due to any cause, assessed up to 5 years after completion of study treatment
This will be a secondary endpoint for the phase III trial, if completed, or for the phase II trial if the phase III trial is not performed.
From randomization until confirmed disease recurrence as assessed by the treating physician or death due to any cause, assessed up to 5 years after completion of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Matthew D Galsky, Alliance for Clinical Trials in Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2024

Primary Completion (Estimated)

September 2, 2030

Study Completion (Estimated)

September 2, 2030

Study Registration Dates

First Submitted

August 10, 2023

First Submitted That Met QC Criteria

August 10, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2023-05980 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA180821 (U.S. NIH Grant/Contract)
  • A032103 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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