EA2176: Phase 3 Clinical Trial of Carboplatin and Paclitaxel +/- Nivolumab in Metastatic Anal Cancer Patients

April 19, 2024 updated by: National Cancer Institute (NCI)

A Randomized Phase III Study of Immune Checkpoint Inhibition With Chemotherapy in Treatment-Naive Metastatic Anal Cancer Patients

This phase 3 trial compares the addition of nivolumab to chemotherapy (carboplatin and paclitaxel) versus usual treatment (chemotherapy alone) for the treatment of anal cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab together with carboplatin and paclitaxel may help doctors find out if the treatment is better or the same as the usual approach.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To demonstrate that anti-PD-1 therapy in combination with carboplatin/weekly paclitaxel results in improved progression-free survival (PFS) versus systemic chemotherapy alone.

SECONDARY OBJECTIVES:

I. To demonstrate that anti-PD-1 therapy in combination with carboplatin/weekly paclitaxel results in improved overall survival (OS) versus systemic chemotherapy alone.

II. To demonstrate that anti-PD-1 therapy in combination with carboplatin/weekly paclitaxel results in improved objective response using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 versus systemic chemotherapy alone.

III. To evaluate toxicity profiles of the two regimens.

OUTLINE: Patients are randomized to 1 of 2 arms. Randomization will be 2:1 favoring the experimental regimen, Arm B.

ARM A: Patients receive paclitaxel intravenously (IV) on days 1, 8, and 15 of each cycle, and carboplatin IV on day 1 of each cycle. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive nivolumab IV over 30 minutes on days 1 and 15 of cycle 1 and then on day 1 only of subsequent cycles, paclitaxel IV on days 1, 8, and 15 of each cycle, and carboplatin on day 1 of each cycle. Treatment repeats every 28 days for up to 6 cycles for carboplatin and paclitaxel, and up to 2 years for nivolumab in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 month, then every 3 months for 2 years.

Study Type

Interventional

Enrollment (Estimated)

205

Phase

  • 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

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 98508
        • Suspended
        • Anchorage Associates in Radiation Medicine
      • Anchorage, Alaska, United States, 99504
        • Suspended
        • Anchorage Radiation Therapy Center
      • Anchorage, Alaska, United States, 99508
        • Suspended
        • Alaska Breast Care and Surgery LLC
      • Anchorage, Alaska, United States, 99508
        • Suspended
        • Alaska Oncology and Hematology LLC
      • Anchorage, Alaska, United States, 99508
        • Suspended
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, United States, 99508
        • Suspended
        • Anchorage Oncology Centre
      • Anchorage, Alaska, United States, 99508
        • Suspended
        • Katmai Oncology Group
      • Anchorage, Alaska, United States, 99508
        • Suspended
        • Providence Alaska Medical Center
    • Arizona
      • Kingman, Arizona, United States, 86401
        • Recruiting
        • Kingman Regional Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Phoenix, Arizona, United States, 85004
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Suspended
        • Mercy Hospital Fort Smith
      • Hot Springs, Arkansas, United States, 71913
        • Suspended
        • CHI Saint Vincent Cancer Center Hot Springs
    • California
      • Anaheim, California, United States, 92806
        • Recruiting
        • Kaiser Permanente-Anaheim
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • Antioch, California, United States, 94531
        • Recruiting
        • Kaiser Permanente-Deer Valley Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • Arroyo Grande, California, United States, 93420
        • Recruiting
        • PCR Oncology
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Arroyo Grande, California, United States, 93420
        • Suspended
        • Mission Hope Medical Oncology - Arroyo Grande
      • Baldwin Park, California, United States, 91706
        • Recruiting
        • Kaiser Permanente-Baldwin Park
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • Bellflower, California, United States, 90706
        • Recruiting
        • Kaiser Permanente-Bellflower
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • Burbank, California, United States, 91505
        • Suspended
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Dublin, California, United States, 94568
        • Recruiting
        • Kaiser Permanente Dublin
        • Principal Investigator:
          • Tatjana Kolevska
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
      • Fontana, California, United States, 92335
        • Recruiting
        • Kaiser Permanente-Fontana
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • Fremont, California, United States, 94538
        • Recruiting
        • Kaiser Permanente-Fremont
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • Fresno, California, United States, 93720
        • Recruiting
        • Kaiser Permanente-Fresno
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • Fresno, California, United States, 93720
        • Suspended
        • Fresno Cancer Center
      • Harbor City, California, United States, 90710
        • Recruiting
        • Kaiser Permanente - Harbor City
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • Irvine, California, United States, 92618
        • Recruiting
        • Kaiser Permanente-Irvine
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars Sinai Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 310-423-8965
        • Principal Investigator:
          • Jun Gong
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Kaiser Permanente Los Angeles Medical Center
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • Los Angeles, California, United States, 90034
        • Recruiting
        • Kaiser Permanente West Los Angeles
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC / Norris Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 323-865-0451
        • Principal Investigator:
          • Syma Iqbal
      • Los Angeles, California, United States, 90020
        • Recruiting
        • Keck Medicine of USC Koreatown
        • Contact:
          • Site Public Contact
          • Phone Number: 213-388-0908
        • Principal Investigator:
          • Syma Iqbal
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Los Angeles General Medical Center
        • Principal Investigator:
          • Syma Iqbal
        • Contact:
      • Modesto, California, United States, 95356
        • Recruiting
        • Kaiser Permanente-Modesto
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • Newport Beach, California, United States, 92663
        • Recruiting
        • USC Norris Oncology/Hematology-Newport Beach
        • Contact:
          • Site Public Contact
          • Phone Number: 323-865-0451
        • Principal Investigator:
          • Syma Iqbal
      • Oakland, California, United States, 94611
        • Recruiting
        • Kaiser Permanente-Oakland
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • Oakland, California, United States, 94611
        • Suspended
        • Kaiser Permanente Oakland-Broadway
      • Ontario, California, United States, 91761
        • Recruiting
        • Kaiser Permanente-Ontario
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Jennifer B. Valerin
      • Panorama City, California, United States, 91402
        • Recruiting
        • Kaiser Permanente - Panorama City
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • Rancho Cordova, California, United States, 95670
        • Suspended
        • Kaiser Permanente-Rancho Cordova Cancer Center
      • Redwood City, California, United States, 94063
        • Suspended
        • Kaiser Permanente-Redwood City
      • Richmond, California, United States, 94801
        • Recruiting
        • Kaiser Permanente-Richmond
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • Riverside, California, United States, 92505
        • Recruiting
        • Kaiser Permanente-Riverside
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • Rohnert Park, California, United States, 94928
        • Suspended
        • Rohnert Park Cancer Center
      • Roseville, California, United States, 95661
        • Recruiting
        • Kaiser Permanente-Roseville
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • Roseville, California, United States, 95678
        • Suspended
        • The Permanente Medical Group-Roseville Radiation Oncology
      • Sacramento, California, United States, 95814
        • Recruiting
        • Kaiser Permanente Downtown Commons
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • Sacramento, California, United States, 95823
        • Recruiting
        • Kaiser Permanente-South Sacramento
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • Sacramento, California, United States, 95823
        • Suspended
        • South Sacramento Cancer Center
      • San Diego, California, United States, 92120
        • Recruiting
        • Kaiser Permanente-San Diego Zion
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • San Diego, California, United States, 92108
        • Active, not recruiting
        • Kaiser Permanente-San Diego Mission
      • San Francisco, California, United States, 94115
        • Recruiting
        • Kaiser Permanente-San Francisco
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • San Jose, California, United States, 95119
        • Recruiting
        • Kaiser Permanente-Santa Teresa-San Jose
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • San Leandro, California, United States, 94577
        • Recruiting
        • Kaiser Permanente San Leandro
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • San Luis Obispo, California, United States, 93401
        • Suspended
        • Pacific Central Coast Health Center-San Luis Obispo
      • San Marcos, California, United States, 92078
        • Recruiting
        • Kaiser Permanente-San Marcos
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • San Rafael, California, United States, 94903
        • Recruiting
        • Kaiser San Rafael-Gallinas
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • Santa Clara, California, United States, 95051
        • Recruiting
        • Kaiser Permanente Medical Center - Santa Clara
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • Santa Maria, California, United States, 93444
        • Suspended
        • Mission Hope Medical Oncology - Santa Maria
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Kaiser Permanente-Santa Rosa
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • South San Francisco, California, United States, 94080
        • Suspended
        • Kaiser Permanente Cancer Treatment Center
      • South San Francisco, California, United States, 94080
        • Recruiting
        • Kaiser Permanente-South San Francisco
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • Stockton, California, United States, 95210
        • Recruiting
        • Kaiser Permanente-Stockton
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • Torrance, California, United States, 90505
        • Suspended
        • Torrance Memorial Physician Network - Cancer Care
      • Torrance, California, United States, 90509
        • Suspended
        • Torrance Memorial Medical Center
      • Vacaville, California, United States, 95688
        • Recruiting
        • Kaiser Permanente Medical Center-Vacaville
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • Vallejo, California, United States, 94589
        • Recruiting
        • Kaiser Permanente-Vallejo
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • Walnut Creek, California, United States, 94596
        • Recruiting
        • Kaiser Permanente-Walnut Creek
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • Woodland Hills, California, United States, 91367
        • Recruiting
        • Kaiser Permanente-Woodland Hills
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
      • Colorado Springs, Colorado, United States, 80907
        • Suspended
        • Rocky Mountain Cancer Centers-Penrose
      • Denver, Colorado, United States, 80210
        • Suspended
        • Porter Adventist Hospital
      • Durango, Colorado, United States, 81301
        • Suspended
        • Mercy Medical Center
      • Durango, Colorado, United States, 81301
        • Suspended
        • Southwest Oncology PC
      • Lakewood, Colorado, United States, 80228
        • Suspended
        • Saint Anthony Hospital
      • Littleton, Colorado, United States, 80122
        • Suspended
        • Littleton Adventist Hospital
      • Longmont, Colorado, United States, 80501
      • Longmont, Colorado, United States, 80501
        • Suspended
        • Rocky Mountain Cancer Centers-Longmont
      • Parker, Colorado, United States, 80138
        • Suspended
        • Parker Adventist Hospital
      • Pueblo, Colorado, United States, 81004
        • Suspended
        • Saint Mary Corwin Medical Center
    • Delaware
      • Frankford, Delaware, United States, 19945
        • Recruiting
        • Beebe South Coastal Health Campus
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • Lewes, Delaware, United States, 19958
        • Suspended
        • Beebe Medical Center
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Helen F Graham Cancer Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, United States, 19713
        • Suspended
        • Delaware Clinical and Laboratory Physicians PA
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Medical Oncology Hematology Consultants PA
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, United States, 19718
        • Suspended
        • Christiana Care Health System-Christiana Hospital
      • Rehoboth Beach, Delaware, United States, 19971
        • Recruiting
        • Beebe Health Campus
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • Seaford, Delaware, United States, 19973
        • Suspended
        • TidalHealth Nanticoke / Allen Cancer Center
      • Wilmington, Delaware, United States, 19801
        • Suspended
        • Christiana Care Health System-Wilmington Hospital
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Recruiting
        • AdventHealth Altamonte
        • Contact:
          • Site Public Contact
          • Phone Number: 407-303-2200
        • Principal Investigator:
          • Mohamedtaki A. Tejani
      • Celebration, Florida, United States, 34747
        • Suspended
        • AdventHealth Celebration
      • Fort Lauderdale, Florida, United States, 33308
        • Recruiting
        • Holy Cross Hospital
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Kissimmee, Florida, United States, 34744
        • Suspended
        • AdventHealth Kissimmee
      • Orlando, Florida, United States, 32803
        • Suspended
        • AdventHealth Medical Group Urology at Orlando
      • Orlando, Florida, United States, 32803
        • Recruiting
        • AdventHealth Orlando
        • Contact:
        • Principal Investigator:
          • Mohamedtaki A. Tejani
      • Orlando, Florida, United States, 32822
        • Suspended
        • AdventHealth East Orlando
      • Pensacola, Florida, United States, 32504
        • Recruiting
        • Sacred Heart Hospital
        • Contact:
        • Principal Investigator:
          • Ranjith B. Dissanayake
      • Winter Park, Florida, United States, 32792
        • Suspended
        • AdventHealth Winter Park
    • Georgia
      • Thomasville, Georgia, United States, 31792
        • Recruiting
        • Lewis Hall Singletary Oncology Center
        • Contact:
        • Principal Investigator:
          • Josh D. Simmons
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • Recruiting
        • Kaiser Permanente Moanalua Medical Center
        • Principal Investigator:
          • Tatjana Kolevska
        • Contact:
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • Saint Luke's Cancer Institute - Boise
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Boise, Idaho, United States, 83706
        • Suspended
        • Saint Alphonsus Cancer Care Center-Boise
      • Caldwell, Idaho, United States, 83605
        • Suspended
        • Saint Alphonsus Cancer Care Center-Caldwell
      • Coeur d'Alene, Idaho, United States, 83814
        • Recruiting
        • Kootenai Health - Coeur d'Alene
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Emmett, Idaho, United States, 83617
        • Suspended
        • Walter Knox Memorial Hospital
      • Fruitland, Idaho, United States, 83619
        • Recruiting
        • Saint Luke's Cancer Institute - Fruitland
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Meridian, Idaho, United States, 83642
        • Suspended
        • Idaho Urologic Institute-Meridian
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Saint Luke's Cancer Institute - Meridian
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Nampa, Idaho, United States, 83686
        • Recruiting
        • Saint Luke's Cancer Institute - Nampa
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Nampa, Idaho, United States, 83687
        • Suspended
        • Saint Alphonsus Cancer Care Center-Nampa
      • 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 Cancer Clinic
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Twin Falls, Idaho, United States, 83301
        • Recruiting
        • Saint Luke's Cancer Institute - Twin Falls
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
    • Illinois
      • Alton, Illinois, United States, 62002
        • Suspended
        • Saint Anthony's Health
      • Aurora, Illinois, United States, 60504
        • Recruiting
        • Rush - Copley Medical Center
        • Contact:
        • Principal Investigator:
          • Kendrith M. Rowland
      • 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
      • Carbondale, Illinois, United States, 62902
        • Suspended
        • Memorial Hospital of Carbondale
      • Carterville, Illinois, United States, 62918
        • Suspended
        • SIH Cancer Institute
      • Carthage, Illinois, United States, 62321
        • Recruiting
        • Illinois CancerCare-Carthage
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Centralia, Illinois, United States, 62801
        • Recruiting
        • Centralia Oncology Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Aparna Kalyan
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois
        • Contact:
          • Site Public Contact
          • Phone Number: 312-355-3046
        • Principal Investigator:
          • Shikha Jain
      • Chicago, Illinois, United States, 60612
        • Active, not recruiting
        • Rush University Medical Center
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Contact:
        • Principal Investigator:
          • Kendrith M. Rowland
      • DeKalb, Illinois, United States, 60115
        • Recruiting
        • Northwestern Medicine Cancer Center Kishwaukee
        • Contact:
        • Principal Investigator:
          • Aparna Kalyan
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois - Decatur
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Decatur, Illinois, United States, 62526
        • Suspended
        • Decatur Memorial Hospital
      • Dixon, Illinois, United States, 61021
        • Recruiting
        • Illinois CancerCare-Dixon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 815-285-7800
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Carle Physician Group-Effingham
        • Contact:
        • Principal Investigator:
          • Kendrith M. Rowland
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Crossroads Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Eureka, Illinois, United States, 61530
        • Recruiting
        • Illinois CancerCare-Eureka
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Galesburg, Illinois, United States, 61401
        • Recruiting
        • Illinois CancerCare-Galesburg
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Galesburg, Illinois, United States, 61401
        • Suspended
        • Western Illinois Cancer Treatment Center
      • Geneva, Illinois, United States, 60134
        • Recruiting
        • Northwestern Medicine Cancer Center Delnor
        • Contact:
        • Principal Investigator:
          • Aparna Kalyan
      • Glenview, Illinois, United States, 60026
        • Recruiting
        • Northwestern Medicine Glenview Outpatient Center
        • Principal Investigator:
          • Aparna Kalyan
        • Contact:
          • Site Public Contact
          • Phone Number: 312-695-1102
      • Grayslake, Illinois, United States, 60030
        • Recruiting
        • Northwestern Medicine Grayslake Outpatient Center
        • Principal Investigator:
          • Aparna Kalyan
        • Contact:
          • Site Public Contact
          • Phone Number: 312-695-1102
      • Harvey, Illinois, United States, 60426
        • Recruiting
        • Ingalls Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Kimberly R. Kruczek
      • 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:
          • Aparna Kalyan
      • 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:
          • Kendrith M. Rowland
      • Mount Vernon, Illinois, United States, 62864
        • Recruiting
        • Good Samaritan Regional Health Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 618-242-4600
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Cancer Care Center of O'Fallon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Orland Park, Illinois, United States, 60462
      • Ottawa, Illinois, United States, 61350
        • Recruiting
        • Illinois CancerCare-Ottawa Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • 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
      • Peoria, Illinois, United States, 61636
        • Suspended
        • Methodist Medical Center of Illinois
      • Peru, Illinois, United States, 61354
        • Recruiting
        • Illinois CancerCare-Peru
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peru, Illinois, United States, 61354
        • Suspended
        • Valley Radiation Oncology
      • Princeton, Illinois, United States, 61356
        • Recruiting
        • Illinois CancerCare-Princeton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • 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
        • Memorial Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Swansea, Illinois, United States, 62226
        • Suspended
        • Southwest Illinois Health Services LLP
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
        • Principal Investigator:
          • Kendrith M. Rowland
      • Urbana, Illinois, United States, 61801
        • Suspended
        • The Carle Foundation Hospital
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • Northwestern Medicine Cancer Center Warrenville
        • Contact:
        • Principal Investigator:
          • Aparna Kalyan
      • Washington, Illinois, United States, 61571
        • Recruiting
        • Illinois CancerCare - Washington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Yorkville, Illinois, United States, 60560
        • Suspended
        • Rush-Copley Healthcare Center
    • Indiana
      • Richmond, Indiana, United States, 47374
        • Recruiting
        • Reid Health
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
    • Iowa
      • Ames, Iowa, United States, 50010
        • Active, not recruiting
        • Mary Greeley Medical Center
      • Ames, Iowa, United States, 50010
        • Active, not recruiting
        • McFarland Clinic - Ames
      • Ankeny, Iowa, United States, 50023
        • Recruiting
        • Mission Cancer and Blood - Ankeny
        • Principal Investigator:
          • Joshua Lukenbill
        • Contact:
          • Site Public Contact
          • Phone Number: 515-282-2921
      • Boone, Iowa, United States, 50036
        • Active, not recruiting
        • McFarland Clinic - Boone
      • Carroll, Iowa, United States, 51401
        • Recruiting
        • Saint Anthony Regional Hospital
        • Contact:
        • Principal Investigator:
          • Joshua Lukenbill
      • Clive, Iowa, United States, 50325
        • Recruiting
        • Medical Oncology and Hematology Associates-West Des Moines
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • Clive, Iowa, United States, 50325
        • Recruiting
        • Mercy Cancer Center-West Lakes
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Council Bluffs, Iowa, United States, 51503
        • Suspended
        • Alegent Health Mercy Hospital
      • Creston, Iowa, United States, 50801
        • Recruiting
        • Greater Regional Medical Center
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Medical Oncology and Hematology Associates-Des Moines
        • Principal Investigator:
          • Joshua Lukenbill
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Broadlawns Medical Center
        • Principal Investigator:
          • Joshua Lukenbill
        • Contact:
          • Site Public Contact
          • Phone Number: 515-282-2200
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Mercy Medical Center - Des Moines
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Mission Cancer and Blood - Laurel
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • Des Moines, Iowa, United States, 50316
        • Suspended
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Iowa Methodist Medical Center
        • Principal Investigator:
          • Joshua Lukenbill
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-6727
      • Fort Dodge, Iowa, United States, 50501
        • Recruiting
        • Trinity Regional Medical Center
        • Principal Investigator:
          • Joshua Lukenbill
        • Contact:
          • Site Public Contact
          • Phone Number: 515-574-8302
      • Fort Dodge, Iowa, United States, 50501
        • Active, not recruiting
        • McFarland Clinic - Trinity Cancer Center
      • Jefferson, Iowa, United States, 50129
        • Active, not recruiting
        • McFarland Clinic - Jefferson
      • Marshalltown, Iowa, United States, 50158
        • Active, not recruiting
        • McFarland Clinic - Marshalltown
      • West Des Moines, Iowa, United States, 50266-7700
        • Suspended
        • Methodist West Hospital
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • Mercy Medical Center-West Lakes
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
    • Kansas
      • Garden City, Kansas, United States, 67846
        • Suspended
        • Central Care Cancer Center - Garden City
      • Great Bend, Kansas, United States, 67530
        • Suspended
        • Central Care Cancer Center - Great Bend
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Suspended
        • Flaget Memorial Hospital
      • Corbin, Kentucky, United States, 40701
        • Suspended
        • Commonwealth Cancer Center-Corbin
      • Lexington, Kentucky, United States, 40504
        • Suspended
        • Saint Joseph Radiation Oncology Resource Center
      • Lexington, Kentucky, United States, 40509
      • London, Kentucky, United States, 40741
        • Suspended
        • Saint Joseph London
      • Louisville, Kentucky, United States, 40202
        • Suspended
        • Jewish Hospital
      • Louisville, Kentucky, United States, 40215
        • Suspended
        • Saints Mary and Elizabeth Hospital
      • Louisville, Kentucky, United States, 40245
        • Suspended
        • UofL Health Medical Center Northeast
      • Shepherdsville, Kentucky, United States, 40165
        • Suspended
        • Jewish Hospital Medical Center South
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70805
        • Recruiting
        • LSU Health Baton Rouge-North Clinic
        • Contact:
        • Principal Investigator:
          • Marshall P. Stagg
      • Baton Rouge, Louisiana, United States, 70809
        • Recruiting
        • Our Lady of the Lake Physicians Group - Medical Oncology
        • Contact:
        • Principal Investigator:
          • Marshall P. Stagg
      • New Orleans, Louisiana, United States, 70112
        • Suspended
        • Louisiana State University Health Science Center
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • University Medical Center New Orleans
        • Contact:
        • Principal Investigator:
          • Rajasree P. Chowdry
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • UMass Memorial Medical Center - University Campus
        • Contact:
        • Principal Investigator:
          • Tasneem Ali
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-865-1125
        • Principal Investigator:
          • Oxana V. Crysler
      • Battle Creek, Michigan, United States, 49017
        • Recruiting
        • Bronson Battle Creek
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Brighton, Michigan, United States, 48114
      • Brighton, Michigan, United States, 48114
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Canton, Michigan, United States, 48188
      • Canton, Michigan, United States, 48188
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Caro, Michigan, United States, 48723
        • Suspended
        • Caro Cancer Center
      • Chelsea, Michigan, United States, 48118
      • Chelsea, Michigan, United States, 48118
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Clarkston, Michigan, United States, 48346
        • Recruiting
        • Hematology Oncology Consultants-Clarkston
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Clarkston, Michigan, United States, 48346
        • Recruiting
        • Newland Medical Associates-Clarkston
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Detroit, Michigan, United States, 48236
        • Recruiting
        • Ascension Saint John Hospital
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Wayne State University/Karmanos Cancer Institute
        • Contact:
        • Principal Investigator:
          • Mohammed N. Al Hallak
      • East China Township, Michigan, United States, 48054
        • Recruiting
        • Great Lakes Cancer Management Specialists-Doctors Park
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Weisberg Cancer Treatment Center
        • Contact:
        • Principal Investigator:
          • Mohammed N. Al Hallak
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesee Cancer and Blood Disease Treatment Center
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesee Hematology Oncology PC
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesys Hurley Cancer Institute
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Hurley Medical Center
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Spectrum Health at Butterworth Campus
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Grand Rapids, Michigan, United States, 49503
        • Suspended
        • Helen DeVos Children's Hospital at Spectrum Health
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Trinity Health Grand Rapids Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Recruiting
        • Academic Hematology Oncology Specialists
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Recruiting
        • Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Suspended
        • Michigan Breast Specialists-Grosse Pointe Woods
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • Bronson Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • West Michigan Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49009
        • Recruiting
        • Ascension Borgess Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49048
        • Suspended
        • Borgess Medical Center
      • Lansing, Michigan, United States, 48910
        • Recruiting
        • Karmanos Cancer Institute at McLaren Greater Lansing
        • Contact:
        • Principal Investigator:
          • Mohammed N. Al Hallak
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • University of Michigan Health - Sparrow Lansing
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Livonia, Michigan, United States, 48154
        • Suspended
        • Hope Cancer Clinic
      • Livonia, Michigan, United States, 48154
        • Recruiting
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Macomb, Michigan, United States, 48044
        • Recruiting
        • Great Lakes Cancer Management Specialists-Macomb Medical Campus
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Macomb, Michigan, United States, 48044
        • Suspended
        • Michigan Breast Specialists-Macomb Township
      • Marlette, Michigan, United States, 48453
        • Suspended
        • Saint Mary's Oncology/Hematology Associates of Marlette
      • Muskegon, Michigan, United States, 49444
        • Recruiting
        • Trinity Health Muskegon Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Niles, Michigan, United States, 49120
        • Suspended
        • Corewell Health Lakeland Hospitals - Niles Hospital
      • Norton Shores, Michigan, United States, 49444
        • Recruiting
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
        • Principal Investigator:
          • Kathleen J. Yost
        • Contact:
      • Novi, Michigan, United States, 48374
        • Recruiting
        • Ascension Providence Hospitals - Novi
        • Contact:
        • Principal Investigator:
          • Susan E. Lyons
      • Pontiac, Michigan, United States, 48341
        • Recruiting
        • 21st Century Oncology-Pontiac
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Pontiac, Michigan, United States, 48341
        • Recruiting
        • Newland Medical Associates-Pontiac
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Pontiac, Michigan, United States, 48341
      • Pontiac, Michigan, United States, 48341
        • Suspended
        • Hope Cancer Center
      • Reed City, Michigan, United States, 49677
        • Recruiting
        • Corewell Health Reed City Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Rochester Hills, Michigan, United States, 48309
        • Suspended
        • Great Lakes Cancer Management Specialists-Rochester Hills
      • Saginaw, Michigan, United States, 48601
        • Recruiting
        • Ascension Saint Mary's Hospital
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Saginaw, Michigan, United States, 48604
        • Recruiting
        • Oncology Hematology Associates of Saginaw Valley PC
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Saint Joseph, Michigan, United States, 49085
        • Suspended
        • Lakeland Medical Center Saint Joseph
      • Saint Joseph, Michigan, United States, 49085
        • Recruiting
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Southfield, Michigan, United States, 48075
        • Recruiting
        • Ascension Providence Hospitals - Southfield
        • Contact:
        • Principal Investigator:
          • Susan E. Lyons
      • Sterling Heights, Michigan, United States, 48312
        • Recruiting
        • Bhadresh Nayak MD PC-Sterling Heights
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Tawas City, Michigan, United States, 48764
        • Recruiting
        • Ascension Saint Joseph Hospital
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Traverse City, Michigan, United States, 49684
        • Recruiting
        • Munson Medical Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Warren, Michigan, United States, 48093
        • Recruiting
        • Great Lakes Cancer Management Specialists-Macomb Professional Building
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Warren, Michigan, United States, 48093
        • Recruiting
        • Saint John Macomb-Oakland Hospital
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Warren, Michigan, United States, 48088
        • Suspended
        • Advanced Breast Care Center PLLC
      • Warren, Michigan, United States, 48093
        • Suspended
        • Macomb Hematology Oncology PC
      • Warren, Michigan, United States, 48093
        • Suspended
        • Michigan Breast Specialists-Warren
      • West Branch, Michigan, United States, 48661
        • Recruiting
        • Saint Mary's Oncology/Hematology Associates of West Branch
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Wyoming, Michigan, United States, 49519
        • Recruiting
        • University of Michigan Health - West
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Ypsilanti, Michigan, United States, 48106
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
      • Burnsville, Minnesota, United States, 55337
        • Suspended
        • Fairview Ridges Hospital
      • Burnsville, Minnesota, United States, 55337
        • Suspended
        • Minnesota Oncology - Burnsville
      • Cambridge, Minnesota, United States, 55008
        • Suspended
        • Cambridge Medical Center
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Mercy Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Fairview Southdale Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Fridley, Minnesota, United States, 55432
        • Active, not recruiting
        • Unity Hospital
      • Maple Grove, Minnesota, United States, 55369
        • Suspended
        • Fairview Clinics and Surgery Center Maple Grove
      • Maplewood, Minnesota, United States, 55109
        • Suspended
        • Minnesota Oncology Hematology PA-Maplewood
      • Maplewood, Minnesota, United States, 55109
        • Suspended
        • Saint John's Hospital - Healtheast
      • Minneapolis, Minnesota, United States, 55415
        • Recruiting
        • Hennepin County Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Minneapolis, Minnesota, United States, 55407
        • Suspended
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, United States, 55454
        • Suspended
        • Health Partners Inc
      • Monticello, Minnesota, United States, 55362
        • Suspended
        • Monticello Cancer Center
      • New Ulm, Minnesota, United States, 56073
        • Suspended
        • New Ulm Medical Center
      • Princeton, Minnesota, United States, 55371
        • Suspended
        • Fairview Northland Medical Center
      • Robbinsdale, Minnesota, United States, 55422
        • Suspended
        • North Memorial Medical Health Center
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Park Nicollet Clinic - Saint Louis Park
        • Contact:
        • Principal Investigator:
          • David M. King
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Regions Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Saint Paul, Minnesota, United States, 55102
        • Recruiting
        • United Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Shakopee, Minnesota, United States, 55379
        • Suspended
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, United States, 55082
        • Suspended
        • Lakeview Hospital
      • Thief River Falls, Minnesota, United States, 56701
        • Suspended
        • Sanford Thief River Falls Medical Center
      • Waconia, Minnesota, United States, 55387
        • Suspended
        • Ridgeview Medical Center
      • Willmar, Minnesota, United States, 56201
        • Suspended
        • Rice Memorial Hospital
      • Woodbury, Minnesota, United States, 55125
        • Suspended
        • Minnesota Oncology Hematology PA-Woodbury
      • Worthington, Minnesota, United States, 56187
        • Suspended
        • Sanford Cancer Center Worthington
      • Wyoming, Minnesota, United States, 55092
        • Suspended
        • Fairview Lakes Medical Center
    • Missouri
      • Ballwin, Missouri, United States, 63011
        • Suspended
        • Saint Louis Cancer and Breast Institute-Ballwin
      • Bolivar, Missouri, United States, 65613
        • Suspended
        • Central Care Cancer Center - Bolivar
      • 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
      • Cape Girardeau, Missouri, United States, 63703
        • Suspended
        • Southeast Cancer Center
      • Chesterfield, Missouri, United States, 63017
        • Recruiting
        • Saint Luke's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 314-205-6936
        • Principal Investigator:
          • Joseph Sokhn
      • Creve Coeur, Missouri, United States, 63141
        • Recruiting
        • Siteman Cancer Center at West County Hospital
        • Contact:
        • Principal Investigator:
          • Olivia Aranha
      • 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
        • Suspended
        • Capital Region Southwest Campus
      • Joplin, Missouri, United States, 64804
        • Suspended
        • Freeman Health System
      • Joplin, Missouri, United States, 64804
        • Suspended
        • Mercy Hospital Joplin
      • Rolla, Missouri, United States, 65401
        • Suspended
        • Delbert Day Cancer Institute at PCRMC
      • Rolla, Missouri, United States, 65401
        • Suspended
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Saint Joseph, Missouri, United States, 64506
        • Suspended
        • Heartland Regional Medical Center
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Olivia Aranha
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
      • Saint Louis, Missouri, United States, 63131
        • Recruiting
        • Missouri Baptist Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Saint Louis, Missouri, United States, 63109
        • Suspended
        • Saint Louis Cancer and Breast Institute-South City
      • Saint Louis, Missouri, United States, 63128
        • Suspended
        • Mercy Hospital South
      • Saint Louis, Missouri, United States, 63129
        • Recruiting
        • Siteman Cancer Center-South County
        • Contact:
        • Principal Investigator:
          • Olivia Aranha
      • Saint Louis, Missouri, United States, 63136
        • Recruiting
        • Siteman Cancer Center at Christian Hospital
        • Contact:
        • Principal Investigator:
          • Olivia Aranha
      • Saint Peters, Missouri, United States, 63376
        • Recruiting
        • Siteman Cancer Center at Saint Peters Hospital
        • Contact:
        • Principal Investigator:
          • Olivia Aranha
      • 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, 65807
        • Recruiting
        • CoxHealth South Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • Springfield, Missouri, United States, 65804
        • Suspended
        • Mercy Hospital Springfield
      • 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
      • Washington, Missouri, United States, 63090
        • Suspended
        • Mercy Hospital Washington
    • 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 Deaconess Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Benefis Healthcare- Sletten Cancer Institute
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Suspended
        • Great Falls Clinic
      • Kalispell, Montana, United States, 59901
        • Recruiting
        • Kalispell Regional Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Missoula, Montana, United States, 59802
        • Suspended
        • Saint Patrick Hospital - Community Hospital
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Community Medical Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • Recruiting
        • Nebraska Medicine-Bellevue
        • Contact:
        • Principal Investigator:
          • Laura L. Tenner
      • Grand Island, Nebraska, United States, 68803
        • Suspended
        • CHI Health Saint Francis
      • Kearney, Nebraska, United States, 68847
        • Suspended
        • CHI Health Good Samaritan
      • Lincoln, Nebraska, United States, 68510
        • Suspended
        • Saint Elizabeth Regional Medical Center
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Laura L. Tenner
      • Omaha, Nebraska, United States, 68118
        • Recruiting
        • Nebraska Medicine-Village Pointe
        • Contact:
          • Site Public Contact
          • Phone Number: 402-559-5600
        • Principal Investigator:
          • Laura L. Tenner
      • Omaha, Nebraska, United States, 68122
        • Suspended
        • Alegent Health Immanuel Medical Center
      • Omaha, Nebraska, United States, 68124
        • Suspended
        • Alegent Health Bergan Mercy Medical Center
      • Omaha, Nebraska, United States, 68130
        • Suspended
        • Alegent Health Lakeside Hospital
      • Omaha, Nebraska, United States, 68131
        • Suspended
        • Creighton University Medical Center
      • Papillion, Nebraska, United States, 68046
        • Suspended
        • Midlands Community Hospital
    • Nevada
      • Carson City, Nevada, United States, 89703
        • Suspended
        • Carson Tahoe Regional Medical Center
      • Henderson, Nevada, United States, 89052
        • Suspended
        • Cancer and Blood Specialists-Henderson
      • Henderson, Nevada, United States, 89052
        • Suspended
        • Comprehensive Cancer Centers of Nevada - Henderson
      • Henderson, Nevada, United States, 89052
        • Suspended
        • Comprehensive Cancer Centers of Nevada-Horizon Ridge
      • Henderson, Nevada, United States, 89052
        • Suspended
        • Las Vegas Cancer Center-Henderson
      • Henderson, Nevada, United States, 89052
        • Suspended
        • OptumCare Cancer Care at Seven Hills
      • Henderson, Nevada, United States, 89074
        • Suspended
        • Comprehensive Cancer Centers of Nevada-Southeast Henderson
      • Henderson, Nevada, United States, 89074
        • Suspended
        • GenesisCare USA - Henderson
      • Henderson, Nevada, United States, 89074
        • Suspended
        • Las Vegas Urology - Green Valley
      • Henderson, Nevada, United States, 89074
        • Suspended
        • Las Vegas Urology - Pebble
      • Henderson, Nevada, United States, 89074
        • Suspended
        • Urology Specialists of Nevada - Green Valley
      • Las Vegas, Nevada, United States, 89102
        • Suspended
        • Desert West Surgery
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • OptumCare Cancer Care at Charleston
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89148
        • Recruiting
        • OptumCare Cancer Care at Fort Apache
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89074
        • Suspended
        • Las Vegas Urology - Pecos
      • Las Vegas, Nevada, United States, 89102
        • Suspended
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, United States, 89103
        • Suspended
        • Hope Cancer Care of Nevada
      • Las Vegas, Nevada, United States, 89106
        • Suspended
        • Radiation Oncology Centers of Nevada Central
      • Las Vegas, Nevada, United States, 89106
        • Suspended
        • Urology Specialists of Nevada - Central
      • Las Vegas, Nevada, United States, 89109
        • Suspended
        • GenesisCare USA - Las Vegas
      • Las Vegas, Nevada, United States, 89109
        • Suspended
        • Sunrise Hospital and Medical Center
      • Las Vegas, Nevada, United States, 89113
        • Suspended
        • Las Vegas Prostate Cancer Center
      • Las Vegas, Nevada, United States, 89113
        • Suspended
        • Las Vegas Urology - Sunset
      • Las Vegas, Nevada, United States, 89113
        • Suspended
        • Urology Specialists of Nevada - Southwest
      • Las Vegas, Nevada, United States, 89119
        • Suspended
        • Radiation Oncology Centers of Nevada Southeast
      • Las Vegas, Nevada, United States, 89128
        • Suspended
        • Ann M Wierman MD LTD
      • Las Vegas, Nevada, United States, 89128
        • Suspended
        • Comprehensive Cancer Centers of Nevada - Northwest
      • Las Vegas, Nevada, United States, 89128
        • Suspended
        • GenesisCare USA - Vegas Tenaya
      • Las Vegas, Nevada, United States, 89128
        • Suspended
        • Las Vegas Urology - Cathedral Rock
      • Las Vegas, Nevada, United States, 89128
        • Suspended
        • Las Vegas Urology - Smoke Ranch
      • Las Vegas, Nevada, United States, 89128
        • Suspended
        • OptumCare Cancer Care at MountainView
      • Las Vegas, Nevada, United States, 89128
        • Suspended
        • Urology Specialists of Nevada - Northwest
      • Las Vegas, Nevada, United States, 89135
        • Suspended
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
      • Las Vegas, Nevada, United States, 89144
        • Suspended
        • Comprehensive Cancer Centers of Nevada - Town Center
      • Las Vegas, Nevada, United States, 89144
        • Suspended
        • Comprehensive Cancer Centers of Nevada-Summerlin
      • Las Vegas, Nevada, United States, 89144
        • Suspended
        • Summerlin Hospital Medical Center
      • Las Vegas, Nevada, United States, 89148-2405
        • Suspended
        • Las Vegas Cancer Center-Medical Center
      • Las Vegas, Nevada, United States, 89148
        • Suspended
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89148
        • Suspended
        • GenesisCare USA - Fort Apache
      • Las Vegas, Nevada, United States, 89169
        • Suspended
        • Comprehensive Cancer Centers of Nevada - Central Valley
      • Las Vegas, Nevada, United States, 89169
        • Suspended
        • University Cancer Center
      • Pahrump, Nevada, United States, 89048
        • Suspended
        • Hope Cancer Care of Nevada-Pahrump
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Regional Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Reno, Nevada, United States, 89503
        • Suspended
        • Saint Mary's Regional Medical Center
      • Reno, Nevada, United States, 89509
        • Suspended
        • Radiation Oncology Associates
    • New Hampshire
      • Concord, New Hampshire, United States, 03301
        • Recruiting
        • New Hampshire Oncology Hematology PA-Concord
        • Contact:
          • Site Public Contact
          • Phone Number: 603-224-2556
        • Principal Investigator:
          • Douglas J. Weckstein
      • Manchester, New Hampshire, United States, 03103
        • Recruiting
        • Solinsky Center for Cancer Care
        • Principal Investigator:
          • Douglas J. Weckstein
        • Contact:
          • Site Public Contact
          • Phone Number: 800-339-6484
    • 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:
          • Rona D. Yaeger
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Rona D. Yaeger
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Rona D. Yaeger
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
        • Contact:
        • Principal Investigator:
          • Sarbajit Mukherjee
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Commack
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Rona D. Yaeger
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Rona D. Yaeger
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Rona D. Yaeger
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Rona D. Yaeger
    • North Carolina
      • Albemarle, North Carolina, United States, 28002
        • Recruiting
        • Atrium Health Stanly/LCI-Albemarle
        • Principal Investigator:
          • Mohamed E. Salem
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Carolinas Medical Center/Levine Cancer Institute
        • Principal Investigator:
          • Mohamed E. Salem
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Charlotte, North Carolina, United States, 28210
        • Recruiting
        • Atrium Health Pineville/LCI-Pineville
        • Principal Investigator:
          • Mohamed E. Salem
        • Contact:
          • Site Public Contact
          • Phone Number: 980-442-2000
      • Charlotte, North Carolina, United States, 28211
        • Recruiting
        • Levine Cancer Institute-SouthPark
        • Principal Investigator:
          • Mohamed E. Salem
        • Contact:
          • Site Public Contact
          • Phone Number: 980-442-2000
      • Charlotte, North Carolina, United States, 28262
        • Recruiting
        • Atrium Health University City/LCI-University
        • Principal Investigator:
          • Mohamed E. Salem
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Charlotte, North Carolina, United States, 28277
        • Recruiting
        • Levine Cancer Institute-Ballantyne
        • Principal Investigator:
          • Mohamed E. Salem
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Clinton, North Carolina, United States, 28328
        • Recruiting
        • Southeastern Medical Oncology Center-Clinton
        • Contact:
        • Principal Investigator:
          • Samer S. Kasbari
      • Concord, North Carolina, United States, 28025
        • Recruiting
        • Atrium Health Cabarrus/LCI-Concord
        • Principal Investigator:
          • Mohamed E. Salem
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Gastonia, North Carolina, United States, 28054
        • Recruiting
        • Levine Cancer Institute-Gaston
        • Principal Investigator:
          • Mohamed E. Salem
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Goldsboro, North Carolina, United States, 27534
        • Recruiting
        • Southeastern Medical Oncology Center-Goldsboro
        • Contact:
        • Principal Investigator:
          • Samer S. Kasbari
      • Jacksonville, North Carolina, United States, 28546
        • Recruiting
        • Southeastern Medical Oncology Center-Jacksonville
        • Principal Investigator:
          • Samer S. Kasbari
        • Contact:
      • Lincolnton, North Carolina, United States, 28092
        • Recruiting
        • Atrium Health Lincoln/LCI-Lincolnton
        • Principal Investigator:
          • Mohamed E. Salem
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Monroe, North Carolina, United States, 28112
        • Recruiting
        • Atrium Health Union/LCI-Union
        • Principal Investigator:
          • Mohamed E. Salem
        • 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
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
      • Fargo, North Dakota, United States, 58122
      • Fargo, North Dakota, United States, 58122
      • Fargo, North Dakota, United States, 58103
        • Suspended
        • Sanford South University Medical Center
      • Fargo, North Dakota, United States, 58103
        • Suspended
        • Southpointe-Sanford Medical Center Fargo
      • Fargo, North Dakota, United States, 58104
        • Suspended
        • Sanford Medical Center Fargo
    • Ohio
      • Beavercreek, Ohio, United States, 45431
        • Suspended
        • Indu and Raj Soin Medical Center
      • Belpre, Ohio, United States, 45714
        • Recruiting
        • Strecker Cancer Center-Belpre
        • Contact:
        • Principal Investigator:
          • Timothy D. Moore
      • Boardman, Ohio, United States, 44512
        • Suspended
        • Saint Elizabeth Boardman Hospital
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Dayton Physicians LLC-Miami Valley South
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Miami Valley Hospital South
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Chillicothe, Ohio, United States, 45601
        • Suspended
        • Adena Regional Medical Center
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Cancer Center-UC Medical Center
        • Contact:
        • Principal Investigator:
          • Davendra P. Sohal
      • Cincinnati, Ohio, United States, 45220
        • Suspended
        • Good Samaritan Hospital - Cincinnati
      • Cincinnati, Ohio, United States, 45236
        • Suspended
        • Oncology Hematology Care Inc-Kenwood
      • Cincinnati, Ohio, United States, 45242
        • Suspended
        • Bethesda North Hospital
      • Cincinnati, Ohio, United States, 45247
        • Suspended
        • TriHealth Cancer Institute-Westside
      • Cincinnati, Ohio, United States, 45255
        • Suspended
        • TriHealth Cancer Institute-Anderson
      • Cleveland, Ohio, United States, 44109
        • Recruiting
        • MetroHealth Medical Center
        • Principal Investigator:
          • William Tse
        • Contact:
      • Columbus, Ohio, United States, 43219
        • Recruiting
        • The Mark H Zangmeister Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Principal Investigator:
          • Shafia Rahman
        • Contact:
      • Columbus, Ohio, United States, 43213
        • Suspended
        • Mount Carmel East Hospital
      • Columbus, Ohio, United States, 43214
        • Suspended
        • Riverside Methodist Hospital
      • Columbus, Ohio, United States, 43222
        • Suspended
        • Mount Carmel Health Center West
      • Columbus, Ohio, United States, 43215
        • Suspended
        • Grant Medical Center
      • Columbus, Ohio, United States, 43228
        • Suspended
        • Doctors Hospital
      • Columbus, Ohio, United States, 43214
        • Suspended
        • Columbus Oncology and Hematology Associates Inc
      • Dayton, Ohio, United States, 45409
        • Recruiting
        • Miami Valley Hospital
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Dayton, Ohio, United States, 45415
        • Recruiting
        • Dayton Physician LLC-Miami Valley Hospital North
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Dayton, Ohio, United States, 45415
        • Recruiting
        • Miami Valley Hospital North
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Dayton, Ohio, United States, 45409
        • Recruiting
        • Dayton Blood and Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 937-276-8320
        • Principal Investigator:
          • Tarek M. Sabagh
      • Delaware, Ohio, United States, 43015
        • Suspended
        • Grady Memorial Hospital
      • Delaware, Ohio, United States, 43015
        • Suspended
        • Delaware Health Center-Grady Cancer Center
      • Dublin, Ohio, United States, 43016
        • Suspended
        • Dublin Methodist Hospital
      • Findlay, Ohio, United States, 45840
        • Recruiting
        • Armes Family Cancer Center
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Findlay, Ohio, United States, 45840
        • Suspended
        • Blanchard Valley Hospital
      • Findlay, Ohio, United States, 45840
        • Suspended
        • Orion Cancer Care
      • Franklin, Ohio, United States, 45005-1066
        • Recruiting
        • Atrium Medical Center-Middletown Regional Hospital
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Franklin, Ohio, United States, 45005
        • Recruiting
        • Dayton Physicians LLC-Atrium
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Gahanna, Ohio, United States, 43230
        • Suspended
        • Central Ohio Breast and Endocrine Surgery
      • Greenville, Ohio, United States, 45331
        • Suspended
        • Dayton Physicians LLC-Wayne
      • Greenville, Ohio, United States, 45331
        • Suspended
        • Wayne Hospital
      • Greenville, Ohio, United States, 45331
        • Recruiting
        • Miami Valley Cancer Care and Infusion
        • Principal Investigator:
          • Tarek M. Sabagh
        • Contact:
          • Site Public Contact
          • Phone Number: 937-569-7515
      • Grove City, Ohio, United States, 43123
        • Suspended
        • Mount Carmel Grove City Hospital
      • Kettering, Ohio, United States, 45409
        • Recruiting
        • Greater Dayton Cancer Center
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Kettering, Ohio, United States, 45429
        • Recruiting
        • Kettering Medical Center
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Lancaster, Ohio, United States, 43130
        • Suspended
        • Fairfield Medical Center
      • Lima, Ohio, United States, 45801
        • Suspended
        • Saint Rita's Medical Center
      • Mansfield, Ohio, United States, 44903
        • Suspended
        • OhioHealth Mansfield Hospital
      • Marietta, Ohio, United States, 45750
        • Recruiting
        • Marietta Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Timothy D. Moore
      • Marion, Ohio, United States, 43302
        • Suspended
        • OhioHealth Marion General Hospital
      • Marysville, Ohio, United States, 43040
        • Recruiting
        • Memorial Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Mount Vernon, Ohio, United States, 43050
        • Suspended
        • Knox Community Hospital
      • Newark, Ohio, United States, 43055
        • Recruiting
        • Licking Memorial Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Newark, Ohio, United States, 43055
        • Suspended
        • Newark Radiation Oncology
      • Perrysburg, Ohio, United States, 43551
        • Suspended
        • Mercy Health Perrysburg Cancer Center
      • Portsmouth, Ohio, United States, 45662
        • Recruiting
        • Southern Ohio Medical Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Springfield, Ohio, United States, 45504
        • Recruiting
        • Springfield Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Timothy D. Moore
      • Springfield, Ohio, United States, 45505
        • Suspended
        • Springfield Regional Medical Center
      • Toledo, Ohio, United States, 43623
        • Suspended
        • Mercy Health - Saint Anne Hospital
      • Toledo, Ohio, United States, 43608
        • Suspended
        • Saint Vincent Mercy Medical Center
      • Troy, Ohio, United States, 45373
        • Recruiting
        • Upper Valley Medical Center
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Troy, Ohio, United States, 45373
        • Suspended
        • Dayton Physicians LLC - Troy
      • Warren, Ohio, United States, 44484
        • Suspended
        • Saint Joseph Warren Hospital
      • West Chester, Ohio, United States, 45069
        • Recruiting
        • University of Cincinnati Cancer Center-West Chester
        • Contact:
        • Principal Investigator:
          • Davendra P. Sohal
      • Westerville, Ohio, United States, 43081
        • Suspended
        • Saint Ann's Hospital
      • Youngstown, Ohio, United States, 44501
        • Suspended
        • Saint Elizabeth Youngstown Hospital
      • Zanesville, Ohio, United States, 43701
        • Recruiting
        • Genesis Healthcare System Cancer Care Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Hassan Hatoum
      • Oklahoma City, Oklahoma, United States, 73120
        • Suspended
        • Mercy Hospital Oklahoma City
    • Oregon
      • Baker City, Oregon, United States, 97814
        • Suspended
        • Saint Alphonsus Medical Center-Baker City
      • Bend, Oregon, United States, 97701
        • Suspended
        • Saint Charles Health System
      • Clackamas, Oregon, United States, 97015
        • Suspended
        • Clackamas Radiation Oncology Center
      • Clackamas, Oregon, United States, 97015
        • Suspended
        • Providence Cancer Institute Clackamas Clinic
      • Coos Bay, Oregon, United States, 97420
        • Suspended
        • Bay Area Hospital
      • Newberg, Oregon, United States, 97132
        • Recruiting
        • Providence Newberg Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Ontario, Oregon, United States, 97914
        • Suspended
        • Saint Alphonsus Medical Center-Ontario
      • 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:
          • Emerson Y. Chen
      • 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:
      • Redmond, Oregon, United States, 97756
        • Suspended
        • Saint Charles Health System-Redmond
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Lehigh Valley Hospital-Cedar Crest
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Bethlehem, Pennsylvania, United States, 18017
        • Recruiting
        • Lehigh Valley Hospital - Muhlenberg
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Chadds Ford, Pennsylvania, United States, 19317
        • Suspended
        • Christiana Care Health System-Concord Health Center
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Contact:
        • Principal Investigator:
          • Sorab Gupta
      • East Stroudsburg, Pennsylvania, United States, 18301
        • Suspended
        • Pocono Medical Center
      • Hazleton, Pennsylvania, United States, 18201
        • Recruiting
        • Geisinger Medical Center-Cancer Center Hazleton
        • Contact:
        • Principal Investigator:
          • Sorab Gupta
      • Hazleton, Pennsylvania, United States, 18201
        • Suspended
        • Lehigh Valley Hospital-Hazleton
      • Lewisburg, Pennsylvania, United States, 17837
        • Recruiting
        • Geisinger Medical Oncology-Lewisburg
        • Contact:
        • Principal Investigator:
          • Sorab Gupta
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Pennsylvania Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 800-789-7366
        • Principal Investigator:
          • David M. Mintzer
      • Pottsville, Pennsylvania, United States, 17901
        • Recruiting
        • Geisinger Cancer Services-Pottsville
        • Contact:
        • Principal Investigator:
          • Sorab Gupta
      • Scranton, Pennsylvania, United States, 18510
        • Recruiting
        • Community Medical Center
        • Contact:
        • Principal Investigator:
          • Sorab Gupta
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Recruiting
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Contact:
        • Principal Investigator:
          • Sorab Gupta
    • South Carolina
      • Greenville, South Carolina, United States, 29601
        • Recruiting
        • Saint Francis Hospital
        • Contact:
        • Principal Investigator:
          • Robert D. Siegel
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • Saint Francis Cancer Center
        • Contact:
        • Principal Investigator:
          • Robert D. Siegel
      • Rock Hill, South Carolina, United States, 29732
        • Recruiting
        • Levine Cancer Institute-Rock Hill
        • Principal Investigator:
          • Mohamed E. Salem
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
      • Sioux Falls, South Dakota, United States, 57117-5134
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • Recruiting
        • Thompson Cancer Survival Center
        • Contact:
          • Site Public Contact
          • Phone Number: 865-331-1812
        • Principal Investigator:
          • David D. Chism
      • Knoxville, Tennessee, United States, 37932
        • Recruiting
        • Thompson Cancer Survival Center - West
        • Contact:
          • Site Public Contact
          • Phone Number: 865-331-1812
        • Principal Investigator:
          • David D. Chism
      • Lenoir City, Tennessee, United States, 37772
        • Recruiting
        • Thompson Oncology Group-Lenoir City
        • Contact:
          • Site Public Contact
          • Phone Number: 865-331-1812
        • Principal Investigator:
          • David D. Chism
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University/Ingram Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-811-8480
        • Principal Investigator:
          • Cathy Eng
      • Oak Ridge, Tennessee, United States, 37830
        • Recruiting
        • Thompson Oncology Group-Oak Ridge
        • Contact:
          • Site Public Contact
          • Phone Number: 865-331-1812
        • Principal Investigator:
          • David D. Chism
    • Texas
      • Bryan, Texas, United States, 77802
        • Suspended
        • Saint Joseph Regional Cancer Center
      • Conroe, Texas, United States, 77384
        • Recruiting
        • MD Anderson in The Woodlands
        • Contact:
        • Principal Investigator:
          • Van K. Morris
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Contact:
        • Principal Investigator:
          • Syed M. Kazmi
      • Dallas, Texas, United States, 75235
        • Recruiting
        • Parkland Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Syed M. Kazmi
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Van K. Morris
      • Houston, Texas, United States, 77079
        • Recruiting
        • MD Anderson West Houston
        • Contact:
        • Principal Investigator:
          • Van K. Morris
      • League City, Texas, United States, 77573
        • Recruiting
        • MD Anderson League City
        • Contact:
        • Principal Investigator:
          • Van K. Morris
      • Sugar Land, Texas, United States, 77478
        • Recruiting
        • MD Anderson in Sugar Land
        • Contact:
        • Principal Investigator:
          • Van K. Morris
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Recruiting
        • Cancer Specialists of Tidewater Limited
        • Contact:
        • Principal Investigator:
          • Khalid Matin
      • Fredericksburg, Virginia, United States, 22408
        • Recruiting
        • Hematology Oncology Associates of Fredericksburg Inc
        • Contact:
        • Principal Investigator:
          • Khalid Matin
      • Gloucester, Virginia, United States, 23061
        • Recruiting
        • Peninsula Cancer Institute-Gloucester
        • Contact:
        • Principal Investigator:
          • Khalid Matin
      • Newport News, Virginia, United States, 23601
        • Recruiting
        • Peninsula Cancer Institute-Newport News
        • Contact:
        • Principal Investigator:
          • Khalid Matin
      • Richmond, Virginia, United States, 23229
        • Recruiting
        • Virginia Cancer Institute
        • Contact:
        • Principal Investigator:
          • Khalid Matin
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University/Massey Cancer Center
        • Contact:
        • Principal Investigator:
          • Khalid Matin
      • Suffolk, Virginia, United States, 23435
        • Recruiting
        • Cancer Specialists of Tidewater-Suffolk
        • Contact:
        • Principal Investigator:
          • Khalid Matin
      • Virginia Beach, Virginia, United States, 23454
        • Recruiting
        • Peninsula Cancer Institute-Cancer Specialists of Tidewater
        • Contact:
        • Principal Investigator:
          • Khalid Matin
      • Williamsburg, Virginia, United States, 23185
        • Recruiting
        • Peninsula Cancer Institute-Williamsburg
        • Contact:
        • Principal Investigator:
          • Khalid Matin
    • Washington
      • Aberdeen, Washington, United States, 98520
        • Suspended
        • Providence Regional Cancer System-Aberdeen
      • Bellevue, Washington, United States, 98004
        • Suspended
        • Overlake Medical Center
      • Bellingham, Washington, United States, 98225
        • Suspended
        • PeaceHealth Saint Joseph Medical Center
      • Bremerton, Washington, United States, 98310
        • Recruiting
        • Harrison HealthPartners Hematology and Oncology-Bremerton
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Bremerton, Washington, United States, 98310
        • Suspended
        • Harrison Medical Center
      • Burien, Washington, United States, 98166
        • Suspended
        • Highline Medical Center-Main Campus
      • Centralia, Washington, United States, 98531
        • Suspended
        • Providence Regional Cancer System-Centralia
      • Edmonds, Washington, United States, 98026
        • Suspended
        • Swedish Cancer Institute-Edmonds
      • Enumclaw, Washington, United States, 98022
        • Suspended
        • Saint Elizabeth Hospital
      • Everett, Washington, United States, 98201
        • Suspended
        • Providence Regional Cancer Partnership
      • Federal Way, Washington, United States, 98003
        • Suspended
        • Saint Francis Hospital
      • Issaquah, Washington, United States, 98029
        • Suspended
        • Swedish Cancer Institute-Issaquah
      • Kennewick, Washington, United States, 99336
        • Recruiting
        • Kadlec Clinic Hematology and Oncology
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Lacey, Washington, United States, 98503
        • Suspended
        • Providence Regional Cancer System-Lacey
      • Lakewood, Washington, United States, 98499
        • Suspended
        • Saint Clare Hospital
      • Longview, Washington, United States, 98632
        • Suspended
        • PeaceHealth Saint John Medical Center
      • Poulsbo, Washington, United States, 98370
        • Active, not recruiting
        • Harrison HealthPartners Hematology and Oncology-Poulsbo
      • Renton, Washington, United States, 98055
        • Recruiting
        • Valley Medical Center
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Seattle, Washington, United States, 98104
        • Suspended
        • Pacific Gynecology Specialists
      • Seattle, Washington, United States, 98107
        • Suspended
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, United States, 98122-5711
        • Suspended
        • Swedish Medical Center-Cherry Hill
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center-First Hill
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Sedro-Woolley, Washington, United States, 98284
        • Suspended
        • PeaceHealth United General Medical Center
      • Shelton, Washington, United States, 98584
        • Suspended
        • Providence Regional Cancer System-Shelton
      • Tacoma, Washington, United States, 98405
        • Suspended
        • Franciscan Research Center-Northwest Medical Plaza
      • Tacoma, Washington, United States, 98405
        • Suspended
        • Northwest Medical Specialties PLLC
      • Vancouver, Washington, United States, 98664
        • Recruiting
        • PeaceHealth Southwest Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Walla Walla, Washington, United States, 99362
        • Suspended
        • Providence Saint Mary Regional Cancer Center
      • Yakima, Washington, United States, 98902
        • Suspended
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
      • Yelm, Washington, United States, 98597
        • Suspended
        • Providence Regional Cancer System-Yelm
    • West Virginia
      • Bridgeport, West Virginia, United States, 26330
        • Suspended
        • United Hospital Center
      • Martinsburg, West Virginia, United States, 25401
        • Suspended
        • WVUH-Berkely Medical Center
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University Healthcare
        • Contact:
        • Principal Investigator:
          • Nour Daboul
      • Parkersburg, West Virginia, United States, 26101
        • Suspended
        • Camden Clark Medical Center
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • Recruiting
        • ThedaCare Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Matthias Weiss
      • Eau Claire, Wisconsin, United States, 54701
      • La Crosse, Wisconsin, United States, 54601
        • Recruiting
        • Gundersen Lutheran Medical Center
        • Contact:
        • Principal Investigator:
          • Kurt Oettel
      • Marshfield, Wisconsin, United States, 54449
      • Milwaukee, Wisconsin, United States, 53226
        • Active, not recruiting
        • Medical College of Wisconsin
      • Minocqua, Wisconsin, United States, 54548
      • Mukwonago, Wisconsin, United States, 53149
        • Recruiting
        • ProHealth D N Greenwald Center
        • Contact:
        • Principal Investigator:
          • Timothy R. Wassenaar
      • New Richmond, Wisconsin, United States, 54017
        • Suspended
        • Cancer Center of Western Wisconsin
      • Oconomowoc, Wisconsin, United States, 53066
        • Recruiting
        • ProHealth Oconomowoc Memorial Hospital
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:
          • Site Public Contact
          • Phone Number: 262-928-7878
      • Rice Lake, Wisconsin, United States, 54868
      • Stevens Point, Wisconsin, United States, 54482
      • 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:
      • Weston, Wisconsin, United States, 54476
    • Wyoming
      • Cody, Wyoming, United States, 82414
        • Suspended
        • Billings Clinic-Cody
      • Sheridan, Wyoming, United States, 82801
        • Suspended
        • Welch Cancer Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient must have inoperable, recurrent, or metastatic disease not amenable to curative therapy
  • Patient must have histological or cytological confirmation of anal squamous cell carcinoma (includes basaloid and cloacogenic lesions) from the primary tumor or a newly diagnosed recurrent/metastatic lesion
  • Patient must be >= 18 years of age
  • Patient must have Eastern Cooperative Oncology Group (ECOG) performance status =< 0-1
  • Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 and based on radiologic assessment performed < 4 weeks prior to randomization
  • Patient receiving palliative (limited-field) radiation therapy is allowed, as long as the lesion treated for palliation is not a target lesion and is > 7 days from completion from palliative radiation
  • Patients with brain metastasis are eligible if patient is asymptomatic and if treatment ended > 3 months prior to randomization. Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression within 4 weeks prior to randomization
  • Absolute neutrophil count >= 1,500/mcL (obtained < 14 days prior to randomization)
  • Platelets >= 100,000/mcL (obtained < 14 days prior to randomization)
  • Hemoglobin (Hb) >= 9 g/dL for males and >= 9 g/dL for females (obtained < 14 days prior to randomization)
  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (obtained < 14 days prior to randomization)
  • Aspartate transaminase (AST)(serum glutamic-oxaloacetic transaminase [SGOT]) /alanine transferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 5 x institutional ULN (obtained < 14 days prior to randomization)
  • Creatinine =< 1.5 x institutional ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula) (obtained < 14 days prior to randomization)

  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy (ART) with CD4 count >= 200 or have a CD4 count < 200 but an undetectable viral load are eligible

    • All HIV+ patients should be under the care of an infectious diseases specialist. If a relationship with an infectious diseases specialist is not established, an infectious disease specialist should be consulted. Records of all viral counts and peripheral T-cell counts should be documented in order to follow these values over the course of treatment
    • All patients must be willing to undergo testing for HIV testing if not tested within the past 12 months
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable or 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
  • Patients with known history or current symptoms of cardiac disease, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. Patients with a history of congestive heart failure (CHF) or who are at risk because of underlying cardiovascular disease or exposure to cardiotoxic drugs must be willing to undergo evaluation of cardiac function including electrocardiogram (EKG) and echocardiogram (ECHO) as clinically indicated
  • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
  • Patients must agree to not receive live vaccines while on this study

Exclusion Criteria:

  • Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All females of childbearing potential must have a blood test or urine study with a minimum sensitivity of 25 IU/L or equivalent units of Bacille Calmette-Guerin (BCG), within 14 days prior to randomization to rule out pregnancy. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  • Women of childbearing potential and sexually active males must not expect to conceive or father children by using accepted and effective method(s) of contraception or to abstain from sexual intercourse for at least one week prior to the start of treatment, and continue for 5 months after the last dose of protocol treatment for women of childbearing potential and 7 months after the last dose of protocol treatment for males who are sexually active with women of childbearing potential (WOCBP)
  • Patient must not have had previous use of systemic chemotherapy or other investigational drugs for the treatment of inoperable recurrent or metastatic anal cancer (previous use of radiotherapy or chemoradiotherapy in this setting is not an exclusion criterion if: 1) non-irradiated target tumor lesions are present at randomization for the purpose of tumor response assessment or 2) in the absence of non-irradiated target tumor lesions, progression of the irradiated tumor lesions according to the RECIST criteria version 1.1 is documented)
  • Patient must not have current or recent (within 30 days prior to randomization) treatment with another investigational drug or participation in another investigational study
  • Patient must not have had prior immunotherapy
  • Patient must not have a history of known hypersensitivity reaction to any platinum or taxane-based chemotherapy or monoclonal antibody
  • Patient must not have active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater). 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, and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or anti-phospholipid syndrome. Patients with any of these are ineligible because of the risk of recurrence or exacerbation of autoimmune disease
  • Patient must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids and adrenal replacement doses < 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if < 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted
  • Patient must not have had major surgery performed =< 28 days prior to randomization
  • Patient must not have a history of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computed tomography (CT) scan
  • Patient must not have a serious active infection requiring IV antibiotics at time of randomization
  • Patient must not have other primary malignancy within the last 3 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer, or any other cancer from which the patient has been disease-free for at least 3 years
  • Patient must not have known peripheral neuropathy > grade 1 at the time of randomization (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible)

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: Arm A (carboplatin, paclitaxel)
Patients receive paclitaxel IV on days 1, 8, and 15 of each cycle, and carboplatin IV on day 1 of each cycle. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carboplatinum
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo
  • JM8
Drug: Paclitaxel
Given IV
Other Names:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Experimental: Arm B (carboplatin, paclitaxel, nivolumab)
Patients receive nivolumab IV over 30 minutes on days 1 and 15 of cycle 1 and then on day 1 only of subsequent cycles, paclitaxel IV on days 1, 8, and 15 of each cycle, and carboplatin on day 1 of each cycle. Treatment repeats every 28 days for up to 6 cycles for carboplatin and paclitaxel, and up to 2 years for nivolumab in the absence of disease progression or unacceptable toxicity.
Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carboplatinum
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo
  • JM8
Biological: Nivolumab
Given IV
Other Names:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo
  • CMAB819
  • Nivolumab Biosimilar CMAB819
  • ABP 206
  • Nivolumab Biosimilar ABP 206
  • BCD-263
  • Nivolumab Biosimilar BCD-263
Drug: Paclitaxel
Given IV
Other Names:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: Up to 2 years
Defined as the first of progressive disease or death due to any cause. Analyzed using a stratified two-sided overall 0.05 level log-rank test. Will utilize standard Eastern Cooperative Oncology Group -American College of Radiology Imaging Network interim monitoring for efficacy evaluation.
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Up to 2 years
ORR is the ratio of the number of patients with a complete response or partial response, as defined by Response Evaluation Criteria in Solid Tumors version 1.1, to the total number of treated patients.
Up to 2 years
Overall survival
Time Frame: Time between treatment randomization and death by any cause, assessed up to 2 years
Evaluated by a stratified log-rank test, and using a two-sided 0.05 level Cochran Mantel-Haenzel.
Time between treatment randomization and death by any cause, assessed up to 2 years
Incidence of adverse events
Time Frame: Up to 2 years
Analyses of toxicity will be via frequency tabulations and percentages by worst degree of toxicity and comparisons will be done via chi-square or Fisher's exact tests as appropriate.
Up to 2 years

Collaborators and Investigators

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

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Cathy Eng, ECOG-ACRIN Cancer Research Group

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)

November 17, 2020

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

June 23, 2020

First Submitted That Met QC Criteria

June 23, 2020

First Posted (Actual)

June 24, 2020

Study Record Updates

Last Update Posted (Estimated)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2020-04334 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA180820 (U.S. NIH Grant/Contract)
  • EA2176 (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

product manufactured in and exported from the U.S.

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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