Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove the Kidney in Metastatic Kidney Cancer, the PROBE Trial (PROBE)

August 11, 2023 updated by: SWOG Cancer Research Network

Phase III Trial of Immunotherapy-Based Combination Therapy With or Without Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma (PROBE Trial)

This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, pembrolizumab, and avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Surgery to remove the kidney, called a nephrectomy, is also considered standard of care; however, doctors who treat kidney cancer do not agree on its benefits. It is not yet known if the addition of surgery to an immunotherapy-based drug combination works better than an immunotherapy-based drug combination alone in treating patients with kidney cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To compare overall survival in participants with newly diagnosed metastatic renal cell carcinoma who are randomized to receive immune checkpoint inhibitor-based combination treatment plus cytoreductive nephrectomy versus immune checkpoint inhibitor-based combination treatment alone.

SECONDARY OBJECTIVES:

I. To compare overall survival between arms in the subset who received their assigned protocol treatment.

II. To assess complications of nephrectomy and post-randomization drug toxicities.

III. To compare objective response rate in metastatic sites between the arms in participants with measurable metastatic disease.

IV. To assess change in diameter of primary tumor at week 12 disease assessment in participants who have received pre-randomization treatment.

BANKING OBJECTIVE:

I. To bank specimens for future correlative studies.

OUTLINE:

PRE-RANDOMIZATION TREATMENT: Treatment naive patients are assigned to 1 of 3 treatment regimens per standard of care.

REGIMEN I: Patients receive nivolumab intravenously (IV) and ipilimumab IV. Treatment repeats every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV on day 1. Cycles repeat every 2-4 weeks in the absence of disease progression or unacceptable toxicity.

REGIMEN II: Patients receive pembrolizumab IV on day 1 and axitinib orally (PO) twice daily (BID) on days 1-21. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

REGIMEN III: Patients receive avelumab IV on day 1 and axitinib PO BID on days 1-14. Cycles repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

NOTE: Some patients may have already completed the standard of care pre-randomization treatment specified above off-trial.

RANDOMIZATION TREATMENT: Between 10-14 weeks from the start of on-trial or off-trial pre-randomization treatment, patients are randomized to 1 of 2 arms.

ARM I: Patients receive nivolumab IV, pembrolizumab IV, or avelumab IV on day 1. Patients also receive axitinib PO BID. Cycles with nivolumab repeat every 2 or 4 weeks, cycles with pembrolizumab repeat every 3 weeks, and cycles with avelumab repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Within 42 days following randomization, patients undergo radical or partial nephrectomy in addition to nivolumab, pembrolizumab, avelumab, and axitinib as in Arm I in the absence of disease progression or unacceptable toxicity. Axitinib should be stopped at least 24 hours prior to surgery.

After completion of trial treatment, patients are followed up every 3 months for the first year, every 6 months for years 2 and 3, and then annually for up to 7 years from randomization.

Study Type

Interventional

Enrollment (Estimated)

364

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 Contact

  • Name: Dana Sparks, MAT
  • Phone Number: 1004 210-614-8808
  • Email: dsparks@swog.org

Study Contact Backup

  • Name: Megan Keim, MS
  • Phone Number: 210-614-8808
  • Email: mkeim@swog.org

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham Cancer Center
        • Principal Investigator:
          • Arnab Basu
        • Contact:
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Recruiting
        • Banner MD Anderson Cancer Center
        • Principal Investigator:
          • Chinedu Mmeje
        • Contact:
          • Site Public Contact
          • Phone Number: 602-747-9738
      • Kingman, Arizona, United States, 86401
        • Recruiting
        • Kingman Regional Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • Banner University Medical Center - Tucson
        • Principal Investigator:
          • Benjamin R. Lee
        • Contact:
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • University of Arizona Cancer Center-North Campus
        • Principal Investigator:
          • Benjamin R. Lee
        • Contact:
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Recruiting
        • Mercy Hospital Fort Smith
        • Contact:
          • Site Public Contact
          • Phone Number: 800-378-9373
        • Principal Investigator:
          • Jay W. Carlson
    • California
      • Arroyo Grande, California, United States, 93420
        • Recruiting
        • PCR Oncology
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Auburn, California, United States, 95602
      • Auburn, California, United States, 95603
        • Recruiting
        • Sutter Cancer Centers Radiation Oncology Services-Auburn
        • Contact:
        • Principal Investigator:
          • Ari D. Baron
      • Berkeley, California, United States, 94704
        • Recruiting
        • Alta Bates Summit Medical Center-Herrick Campus
        • Contact:
        • Principal Investigator:
          • Ari D. Baron
      • Buena Park, California, United States, 90621
        • Recruiting
        • Keck Medicine of USC Buena Park
        • Contact:
          • Site Public Contact
          • Phone Number: 714-522-0908
        • Principal Investigator:
          • Varsha Tulpule
      • Cameron Park, California, United States, 95682
        • Recruiting
        • Sutter Cancer Centers Radiation Oncology Services-Cameron Park
        • Contact:
        • Principal Investigator:
          • Ari D. Baron
      • Castro Valley, California, United States, 94546
      • Davis, California, United States, 95616
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center
        • Principal Investigator:
          • Abhishek Tripathi
        • Contact:
      • Fremont, California, United States, 94538
        • Recruiting
        • Palo Alto Medical Foundation-Fremont
        • Contact:
        • Principal Investigator:
          • Ari D. Baron
      • Huntington Beach, California, United States, 92648
        • Recruiting
        • Keck Medicine of USC Huntington Beach
        • Contact:
        • Principal Investigator:
          • Varsha Tulpule
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA / Jonsson Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 888-798-0719
        • Principal Investigator:
          • Brian Shuch
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars Sinai Medical Center
        • Principal Investigator:
          • Hyung L. Kim
        • Contact:
          • Site Public Contact
          • Phone Number: 310-423-8965
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC / Norris Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 323-865-0451
        • Principal Investigator:
          • Varsha Tulpule
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Los Angeles County-USC Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 323-865-0451
        • Principal Investigator:
          • Varsha Tulpule
      • Los Angeles, California, United States, 90020
        • Recruiting
        • Keck Medicine of USC Koreatown
        • Contact:
          • Site Public Contact
          • Phone Number: 213-388-0908
        • Principal Investigator:
          • Varsha Tulpule
      • Modesto, California, United States, 95355
      • Mountain View, California, United States, 94040
        • Recruiting
        • Palo Alto Medical Foundation-Camino Division
        • Contact:
        • Principal Investigator:
          • Ari D. Baron
      • Mountain View, California, United States, 94040
        • Recruiting
        • Palo Alto Medical Foundation-Gynecologic Oncology
        • Contact:
        • Principal Investigator:
          • Ari D. Baron
      • Newport Beach, California, United States, 92663
        • Recruiting
        • USC Norris Oncology/Hematology-Newport Beach
        • Contact:
          • Site Public Contact
          • Phone Number: 323-865-0451
        • Principal Investigator:
          • Varsha Tulpule
      • Novato, California, United States, 94945
        • Recruiting
        • Sutter Cancer Research Consortium
        • Contact:
        • Principal Investigator:
          • Ari D. Baron
      • Palo Alto, California, United States, 94301
        • Recruiting
        • Palo Alto Medical Foundation Health Care
        • Contact:
        • Principal Investigator:
          • Ari D. Baron
      • Pasadena, California, United States, 91105
        • Recruiting
        • Keck Medical Center of USC Pasadena
        • Contact:
          • Site Public Contact
          • Phone Number: 323-865-0451
        • Principal Investigator:
          • Varsha Tulpule
      • Roseville, California, United States, 95661
        • Recruiting
        • Sutter Cancer Centers Radiation Oncology Services-Roseville
        • Contact:
        • Principal Investigator:
          • Ari D. Baron
      • Roseville, California, United States, 95661
        • Recruiting
        • Sutter Roseville Medical Center
        • Contact:
        • Principal Investigator:
          • Ari D. Baron
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 916-734-3089
        • Principal Investigator:
          • Shuchi Gulati
      • Sacramento, California, United States, 95816
        • Recruiting
        • Sutter Medical Center Sacramento
        • Contact:
        • Principal Investigator:
          • Ari D. Baron
      • San Francisco, California, United States, 94115
        • Recruiting
        • California Pacific Medical Center-Pacific Campus
        • Contact:
        • Principal Investigator:
          • Ari D. Baron
      • San Mateo, California, United States, 94401
        • Recruiting
        • Mills Health Center
        • Principal Investigator:
          • Ari D. Baron
        • Contact:
      • Santa Cruz, California, United States, 95065
        • Recruiting
        • Palo Alto Medical Foundation-Santa Cruz
        • Contact:
        • Principal Investigator:
          • Ari D. Baron
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Sutter Pacific Medical Foundation
        • Contact:
        • Principal Investigator:
          • Ari D. Baron
      • South Pasadena, California, United States, 91030
        • Recruiting
        • City of Hope South Pasadena
        • Principal Investigator:
          • Abhishek Tripathi
        • Contact:
      • Sunnyvale, California, United States, 94086
        • Recruiting
        • Palo Alto Medical Foundation-Sunnyvale
        • Contact:
        • Principal Investigator:
          • Ari D. Baron
      • Tarzana, California, United States, 91356
        • Recruiting
        • Cedars-Sinai Cancer - Tarzana
        • Contact:
          • Site Public Contact
          • Phone Number: 818-981-3818
        • Principal Investigator:
          • Hyung L. Kim
      • Upland, California, United States, 91786
        • Recruiting
        • City of Hope Upland
        • Principal Investigator:
          • Abhishek Tripathi
        • Contact:
      • Vacaville, California, United States, 95687
        • Recruiting
        • Sutter Cancer Centers Radiation Oncology Services-Vacaville
        • Contact:
        • Principal Investigator:
          • Ari D. Baron
      • Vallejo, California, United States, 94589
        • Recruiting
        • Sutter Solano Medical Center/Cancer Center
        • Contact:
        • Principal Investigator:
          • Ari D. Baron
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • MedStar Washington Hospital Center
        • Contact:
          • Site Public Contact
          • Phone Number: 202-877-8839
        • Principal Investigator:
          • Suthee Rapisuwon
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Recruiting
        • AdventHealth Altamonte
        • Contact:
          • Site Public Contact
          • Phone Number: 407-303-2200
        • Principal Investigator:
          • Carlos A. Alemany
      • Celebration, Florida, United States, 34747
        • Recruiting
        • AdventHealth Celebration
        • Principal Investigator:
          • Carlos A. Alemany
        • Contact:
          • Site Public Contact
          • Phone Number: 407-303-4120
      • Kissimmee, Florida, United States, 34744
        • Recruiting
        • AdventHealth Kissimmee
        • Principal Investigator:
          • Carlos A. Alemany
        • Contact:
          • Site Public Contact
          • Phone Number: 407-846-4343
      • Orlando, Florida, United States, 32803
        • Recruiting
        • AdventHealth Orlando
        • Principal Investigator:
          • Carlos A. Alemany
        • Contact:
      • Orlando, Florida, United States, 32803
        • Recruiting
        • AdventHealth Medical Group Urology at Orlando
        • Principal Investigator:
          • Carlos A. Alemany
        • Contact:
          • Site Public Contact
          • Phone Number: 407-897-3499
      • Orlando, Florida, United States, 32822
        • Recruiting
        • AdventHealth East Orlando
        • Principal Investigator:
          • Carlos A. Alemany
        • Contact:
          • Site Public Contact
          • Phone Number: 407-303-8110
      • Orlando, Florida, United States, 32806
      • Winter Park, Florida, United States, 32792
        • Recruiting
        • AdventHealth Winter Park
        • Principal Investigator:
          • Carlos A. Alemany
        • Contact:
          • Site Public Contact
          • Phone Number: 407-646-7000
    • Illinois
      • Alton, Illinois, United States, 62002
        • Recruiting
        • Saint Anthony's Health
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 618-463-5623
      • Aurora, Illinois, United States, 60504
        • Recruiting
        • Rush - Copley Medical Center
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Barrington, Illinois, United States, 60010
        • Recruiting
        • Advocate Good Shepherd Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-842-4847
        • Principal Investigator:
          • Adam P. Siegel
      • Bloomington, Illinois, United States, 61704
        • Recruiting
        • Illinois CancerCare-Bloomington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Burr Ridge, Illinois, United States, 60527
        • Recruiting
        • Loyola Center for Health at Burr Ridge
        • Principal Investigator:
          • Joseph I. Clark
        • Contact:
          • Site Public Contact
          • Phone Number: 708-216-9000
      • Canton, Illinois, United States, 61520
        • Recruiting
        • Illinois CancerCare-Canton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Carbondale, Illinois, United States, 62902
        • Recruiting
        • Memorial Hospital of Carbondale
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Carterville, Illinois, United States, 62918
        • Recruiting
        • SIH Cancer Institute
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • 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:
      • Centralia, Illinois, United States, 62801
        • Recruiting
        • Saint Mary's Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
        • Principal Investigator:
          • Alan Tan
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Sosman
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois
        • Principal Investigator:
          • Daniel Moreira
        • Contact:
          • Site Public Contact
          • Phone Number: 312-355-3046
      • Chicago, Illinois, United States, 60657
        • Recruiting
        • Advocate Illinois Masonic Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 773-296-5360
        • Principal Investigator:
          • Adam P. Siegel
      • Chicago, Illinois, United States, 60637
        • Active, not recruiting
        • University of Chicago Comprehensive Cancer Center
      • Crystal Lake, Illinois, United States, 60014
        • Recruiting
        • AMG Crystal Lake - Oncology
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • DeKalb, Illinois, United States, 60115
        • Recruiting
        • Northwestern Medicine Cancer Center Kishwaukee
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Sosman
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois - Decatur
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Decatur Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Dixon, Illinois, United States, 61021
        • Recruiting
        • Illinois CancerCare-Dixon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 815-285-7800
      • Downers Grove, Illinois, United States, 60515
        • Recruiting
        • Advocate Good Samaritan Hospital
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Carle Physician Group-Effingham
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Crossroads Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Elgin, Illinois, United States, 60123
        • Recruiting
        • Advocate Sherman Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-429-2907
        • Principal Investigator:
          • Adam P. Siegel
      • Elmhurst, Illinois, United States, 60126
        • Recruiting
        • Elmhurst Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Brian C. Myre
      • 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
        • Recruiting
        • Western Illinois Cancer Treatment Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 309-344-2831
      • Geneva, Illinois, United States, 60134
        • Recruiting
        • Northwestern Medicine Cancer Center Delnor
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Sosman
      • Hazel Crest, Illinois, United States, 60429
        • Recruiting
        • Advocate South Suburban Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 708-799-9995
        • Principal Investigator:
          • Adam P. Siegel
      • Homer Glen, Illinois, United States, 60491
        • Recruiting
        • Loyola Medicine Homer Glen
        • Principal Investigator:
          • Joseph I. Clark
        • Contact:
          • Site Public Contact
          • Phone Number: 708-216-9000
      • 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:
          • Jeffrey A. Sosman
      • Libertyville, Illinois, United States, 60048
        • Recruiting
        • AMG Libertyville - Oncology
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Libertyville, Illinois, United States, 60048
        • Recruiting
        • Condell Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Macomb, Illinois, United States, 61455
        • Recruiting
        • Illinois CancerCare-Macomb
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Mattoon, Illinois, United States, 61938
        • Recruiting
        • Carle Physician Group-Mattoon/Charleston
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 708-226-4357
        • Principal Investigator:
          • Joseph I. Clark
      • Melrose Park, Illinois, United States, 60160
        • Recruiting
        • Marjorie Weinberg Cancer Center at Loyola-Gottlieb
        • Principal Investigator:
          • Joseph I. Clark
        • Contact:
          • Site Public Contact
          • Phone Number: 708-450-4554
      • 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
      • Naperville, Illinois, United States, 60540
        • Recruiting
        • Edward Hospital/Cancer Center
        • Principal Investigator:
          • Brian C. Myre
        • Contact:
          • Site Public Contact
          • Phone Number: 630-646-6075
      • New Lenox, Illinois, United States, 60451
        • Active, not recruiting
        • UC Comprehensive Cancer Center at Silver Cross
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Cancer Care Center of O'Fallon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Oak Lawn, Illinois, United States, 60453-2699
        • Recruiting
        • Advocate Christ Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-323-8622
        • Principal Investigator:
          • Adam P. Siegel
      • Orland Park, Illinois, United States, 60462
        • Active, not recruiting
        • University of Chicago Medicine-Orland Park
      • Ottawa, Illinois, United States, 61350
        • Recruiting
        • Illinois CancerCare-Ottawa Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Park Ridge, Illinois, United States, 60068
        • Recruiting
        • Advocate Lutheran General Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-384-3621
        • Principal Investigator:
          • Adam P. Siegel
      • Pekin, Illinois, United States, 61554
        • Recruiting
        • Illinois CancerCare-Pekin
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peoria, Illinois, United States, 61615
        • Recruiting
        • Illinois CancerCare-Peoria
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peoria, Illinois, United States, 61636
        • Recruiting
        • Methodist Medical Center of Illinois
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peru, Illinois, United States, 61354
        • Recruiting
        • Illinois CancerCare-Peru
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peru, Illinois, United States, 61354
        • Recruiting
        • Valley Radiation Oncology
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 815-664-4141
      • Plainfield, Illinois, United States, 60585
        • Recruiting
        • Edward Hospital/Cancer Center?Plainfield
        • Principal Investigator:
          • Brian C. Myre
        • Contact:
      • 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:
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • The Carle Foundation Hospital
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • Northwestern Medicine Cancer Center Warrenville
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Sosman
      • Washington, Illinois, United States, 61571
        • Recruiting
        • Illinois CancerCare - Washington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Yorkville, Illinois, United States, 60560
        • Recruiting
        • Rush-Copley Healthcare Center
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
    • Indiana
      • Richmond, Indiana, United States, 47374
        • Recruiting
        • Reid Health
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
    • Iowa
      • Ames, Iowa, United States, 50010
        • Recruiting
        • Mary Greeley Medical Center
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Ames, Iowa, United States, 50010
        • Recruiting
        • McFarland Clinic - Ames
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
      • Boone, Iowa, United States, 50036
        • Recruiting
        • McFarland Clinic - Boone
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Carroll, Iowa, United States, 51401
        • Active, not recruiting
        • Saint Anthony Regional Hospital
      • Des Moines, Iowa, United States, 50314
        • Active, not recruiting
        • Broadlawns Medical Center
      • Des Moines, Iowa, United States, 50309
        • Active, not recruiting
        • Medical Oncology and Hematology Associates-Des Moines
      • Des Moines, Iowa, United States, 50309
        • Active, not recruiting
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50316
        • Active, not recruiting
        • Iowa Lutheran Hospital
      • Fort Dodge, Iowa, United States, 50501
        • Active, not recruiting
        • Trinity Regional Medical Center
      • Fort Dodge, Iowa, United States, 50501
        • Recruiting
        • McFarland Clinic - Trinity Cancer Center
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Jefferson, Iowa, United States, 50129
        • Recruiting
        • McFarland Clinic - Jefferson
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Marshalltown, Iowa, United States, 50158
        • Recruiting
        • McFarland Clinic - Marshalltown
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • West Des Moines, Iowa, United States, 50266-7700
        • Active, not recruiting
        • Methodist West Hospital
    • Kansas
      • Garden City, Kansas, United States, 67846
        • Recruiting
        • Central Care Cancer Center - Garden City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Great Bend, Kansas, United States, 67530
        • Recruiting
        • Central Care Cancer Center - Great Bend
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky/Markey Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 859-257-3379
        • Principal Investigator:
          • Zin W. Myint
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Suspended
        • Hematology/Oncology Clinic PLLC
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • East Jefferson General Hospital
        • Contact:
        • Principal Investigator:
          • Jessie R. Gills
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • LSU Healthcare Network / Metairie Multi-Specialty Clinic
        • Contact:
        • Principal Investigator:
          • Jessie R. Gills
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • University Medical Center New Orleans
        • Contact:
        • Principal Investigator:
          • Jessie R. Gills
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Louisiana State University Health Science Center
        • Contact:
        • Principal Investigator:
          • Jessie R. Gills
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Tulane University Health Sciences Center
        • Contact:
          • Site Public Contact
          • Phone Number: 504-988-6121
        • Principal Investigator:
          • Mark Sides
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Comprehensive Cancer Center
        • Principal Investigator:
          • Ulka N. Vaishampayan
        • Contact:
          • Site Public Contact
          • Phone Number: 800-865-1125
      • Battle Creek, Michigan, United States, 49017
        • Recruiting
        • Bronson Battle Creek
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Brighton, Michigan, United States, 48116
        • Recruiting
        • University of Michigan - Brighton Center for Specialty Care
        • Principal Investigator:
          • Ulka N. Vaishampayan
        • Contact:
          • Site Public Contact
          • Phone Number: 800-865-1125
      • Brownstown, Michigan, United States, 48183
        • Active, not recruiting
        • Henry Ford Cancer Institute-Downriver
      • Clinton Township, Michigan, United States, 48038
        • Active, not recruiting
        • Henry Ford Macomb Hospital-Clinton Township
      • Clinton Township, Michigan, United States, 48038
        • Active, not recruiting
        • Henry Ford Hematology Oncology - Hayes
      • Dearborn, Michigan, United States, 48126
        • Active, not recruiting
        • Henry Ford Medical Center-Fairlane
      • Detroit, Michigan, United States, 48202
        • Active, not recruiting
        • Henry Ford Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Helen DeVos Children's Hospital at Spectrum Health
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Spectrum Health at Butterworth Campus
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Trinity Health Grand Rapids Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Jackson, Michigan, United States, 49201
        • Active, not recruiting
        • Allegiance Health
      • 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
        • Recruiting
        • Borgess Medical Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Muskegon, Michigan, United States, 49444
        • Recruiting
        • Trinity Health Muskegon Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Niles, Michigan, United States, 49120
        • Recruiting
        • Lakeland Hospital Niles
        • Principal Investigator:
          • Kathleen J. Yost
        • Contact:
          • Site Public Contact
          • Phone Number: 616-391-1230
      • 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, 48377
        • Active, not recruiting
        • Henry Ford Medical Center-Columbus
      • Reed City, Michigan, United States, 49677
        • Recruiting
        • Spectrum Health Reed City Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Saint Joseph, Michigan, United States, 49085
        • Recruiting
        • Marie Yeager Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Saint Joseph, Michigan, United States, 49085
        • Recruiting
        • Lakeland Medical Center Saint Joseph
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Shelby, Michigan, United States, 48315
        • Suspended
        • Henry Ford Macomb Health Center - Shelby Township
      • Traverse City, Michigan, United States, 49684
        • Recruiting
        • Munson Medical Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • West Bloomfield, Michigan, United States, 48322
        • Active, not recruiting
        • Henry Ford West Bloomfield Hospital
      • Wyandotte, Michigan, United States, 48192
        • Active, not recruiting
        • Henry Ford Wyandotte Hospital
      • Wyoming, Michigan, United States, 49519
        • Recruiting
        • University of Michigan Health - West
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Recruiting
        • Minnesota Oncology - Burnsville
        • Contact:
        • Principal Investigator:
          • David M. King
      • Burnsville, Minnesota, United States, 55337
        • Suspended
        • Fairview Ridges Hospital
      • Cambridge, Minnesota, United States, 55008
        • Recruiting
        • Cambridge Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • 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
        • Recruiting
        • Unity Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Maple Grove, Minnesota, United States, 55369
        • Recruiting
        • Fairview Clinics and Surgery Center Maple Grove
        • Contact:
        • Principal Investigator:
          • David M. King
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Minnesota Oncology Hematology PA-Maplewood
        • Contact:
        • Principal Investigator:
          • David M. King
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Saint John's Hospital - Healtheast
        • Contact:
        • Principal Investigator:
          • David M. King
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott-Northwestern Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Minneapolis, Minnesota, United States, 55415
        • Recruiting
        • Hennepin County Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Minneapolis, Minnesota, United States, 55454
        • Recruiting
        • Health Partners Inc
        • Contact:
        • Principal Investigator:
          • David M. King
      • Monticello, Minnesota, United States, 55362
        • Recruiting
        • Monticello Cancer Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • New Ulm, Minnesota, United States, 56073
        • Recruiting
        • New Ulm Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Princeton, Minnesota, United States, 55371
        • Recruiting
        • Fairview Northland Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Robbinsdale, Minnesota, United States, 55422
        • Recruiting
        • North Memorial Medical Health Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • 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
        • Recruiting
        • Saint Francis Regional Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Stillwater, Minnesota, United States, 55082
        • Recruiting
        • Lakeview Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Waconia, Minnesota, United States, 55387
        • Recruiting
        • Ridgeview Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Willmar, Minnesota, United States, 56201
        • Recruiting
        • Rice Memorial Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Woodbury, Minnesota, United States, 55125
        • Recruiting
        • Minnesota Oncology Hematology PA-Woodbury
        • Contact:
        • Principal Investigator:
          • David M. King
      • Wyoming, Minnesota, United States, 55092
        • Recruiting
        • Fairview Lakes Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
    • Mississippi
      • Gulfport, Mississippi, United States, 39502
        • Recruiting
        • Gulfport Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Jessie R. Gills
    • Missouri
      • Ballwin, Missouri, United States, 63011
        • Recruiting
        • Saint Louis Cancer and Breast Institute-Ballwin
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7058
      • Bolivar, Missouri, United States, 65613
        • Recruiting
        • Central Care Cancer Center - Bolivar
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Branson, Missouri, United States, 65616
        • Recruiting
        • Cox Cancer Center Branson
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • 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
        • Recruiting
        • Southeast Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 573-651-5550
      • 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
        • Recruiting
        • Capital Region Southwest Campus
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Freeman Health System
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Mercy Hospital Joplin
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Delbert Day Cancer Institute at PCRMC
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Mercy Clinic-Rolla-Cancer and Hematology
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 573-458-6379
      • Saint Joseph, Missouri, United States, 64506
        • Recruiting
        • Heartland Regional Medical Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • 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
        • Recruiting
        • Saint Louis Cancer and Breast Institute-South City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-353-1870
      • Saint Louis, Missouri, United States, 63128
        • Recruiting
        • Mercy Hospital South
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Sainte Genevieve, Missouri, United States, 63670
        • Recruiting
        • Sainte Genevieve County Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Springfield, Missouri, United States, 65804
        • Recruiting
        • Mercy Hospital Springfield
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • CoxHealth South Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • 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
        • Missouri Baptist Outpatient Center-Sunset Hills
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Washington, Missouri, United States, 63090
        • Recruiting
        • Mercy Hospital Washington
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 636-390-1600
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
        • Contact:
          • Site Public Contact
          • Phone Number: 402-334-4773
        • Principal Investigator:
          • Ralph J. Hauke
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Nebraska Methodist Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 402-354-5144
        • Principal Investigator:
          • Ralph J. Hauke
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Oncology Associates PC
        • Contact:
          • Site Public Contact
          • Phone Number: 402-354-5860
          • Email: info@oa-oc.com
        • Principal Investigator:
          • Ralph J. Hauke
    • Nevada
      • Carson City, Nevada, United States, 89703
        • Recruiting
        • Carson Tahoe Regional Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • Cancer and Blood Specialists-Henderson
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • Comprehensive Cancer Centers of Nevada - Henderson
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • Comprehensive Cancer Centers of Nevada-Horizon Ridge
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • OptumCare Cancer Care at Seven Hills
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89074
        • Recruiting
        • Comprehensive Cancer Centers of Nevada-Southeast Henderson
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89074
        • Recruiting
        • GenesisCare USA - Henderson
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89074
        • Recruiting
        • Las Vegas Urology - Green Valley
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Henderson, Nevada, United States, 89074
        • Recruiting
        • Las Vegas Urology - Pebble
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Henderson, Nevada, United States, 89074
        • Recruiting
        • Urology Specialists of Nevada - Green Valley
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Henderson, Nevada, United States, 89052
        • Suspended
        • Las Vegas Cancer Center-Henderson
      • Las Vegas, Nevada, United States, 89074
        • Recruiting
        • Las Vegas Urology - Pecos
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • 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, 89102
        • Recruiting
        • University Medical Center of Southern Nevada
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89103
        • Recruiting
        • Hope Cancer Care of Nevada
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Radiation Oncology Centers of Nevada Central
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Urology Specialists of Nevada - Central
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89109
        • Recruiting
        • GenesisCare USA - Las Vegas
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89109
        • Recruiting
        • Sunrise Hospital and Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89113
        • Recruiting
        • Las Vegas Prostate Cancer Center
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89113
        • Recruiting
        • Las Vegas Urology - Sunset
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89113
        • Recruiting
        • Urology Specialists of Nevada - Southwest
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89119
        • Recruiting
        • Radiation Oncology Centers of Nevada Southeast
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Ann M Wierman MD LTD
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Comprehensive Cancer Centers of Nevada - Northwest
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • GenesisCare USA - Vegas Tenaya
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Las Vegas Urology - Cathedral Rock
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Las Vegas Urology - Smoke Ranch
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • OptumCare Cancer Care at MountainView
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Urology Specialists of Nevada - Northwest
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89135
        • Recruiting
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Comprehensive Cancer Centers of Nevada - Town Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Comprehensive Cancer Centers of Nevada-Summerlin
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Summerlin Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89148
        • Recruiting
        • Comprehensive Cancer Centers of Nevada
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89148
        • Recruiting
        • GenesisCare USA - Fort Apache
        • 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, 89169
        • Recruiting
        • Comprehensive Cancer Centers of Nevada - Central Valley
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89169
        • Recruiting
        • University Cancer Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89148-2405
        • Suspended
        • Las Vegas Cancer Center-Medical Center
      • Pahrump, Nevada, United States, 89048
        • Recruiting
        • Hope Cancer Care of Nevada-Pahrump
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Regional Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Reno, Nevada, United States, 89503
        • Recruiting
        • Saint Mary's Regional Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Reno, Nevada, United States, 89509
        • Recruiting
        • Radiation Oncology Associates
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
        • Contact:
        • Principal Investigator:
          • John D. Seigne
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 201-996-2879
        • Principal Investigator:
          • Robert S. Alter
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • University of New Mexico Cancer Center
        • Contact:
        • Principal Investigator:
          • Neda Hashemi Sadraei
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
        • Contact:
        • Principal Investigator:
          • Saby George
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Northwell Health/Center for Advanced Medicine
        • Contact:
          • Site Public Contact
          • Phone Number: 516-734-8896
        • Principal Investigator:
          • Thomas P. Bradley
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Contact:
          • Site Public Contact
          • Phone Number: 585-275-5830
        • Principal Investigator:
          • Paul M. Barr
      • Sleepy Hollow, New York, United States, 10591
        • Recruiting
        • Phelps Memorial Hospital Center
        • Contact:
          • Site Public Contact
          • Phone Number: 914-366-1600
        • Principal Investigator:
          • Thomas P. Bradley
    • North Carolina
      • Clinton, North Carolina, United States, 28328
        • Active, not recruiting
        • Southeastern Medical Oncology Center-Clinton
      • Goldsboro, North Carolina, United States, 27534
        • Active, not recruiting
        • Southeastern Medical Oncology Center-Goldsboro
      • Jacksonville, North Carolina, United States, 28546
        • Active, not recruiting
        • Southeastern Medical Oncology Center-Jacksonville
    • Ohio
      • Avon, Ohio, United States, 44011
        • Recruiting
        • UH Seidman Cancer Center at UH Avon Health Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-641-2422
        • Principal Investigator:
          • Pedro Barata
      • Beachwood, Ohio, United States, 44122
        • Recruiting
        • UHHS-Chagrin Highlands Medical Center
        • Contact:
        • Principal Investigator:
          • Pedro Barata
      • Beavercreek, Ohio, United States, 45431
        • Recruiting
        • Indu and Raj Soin Medical Center
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Boardman, Ohio, United States, 44512
        • Recruiting
        • Saint Elizabeth Boardman Hospital
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Dayton Physicians LLC-Miami Valley South
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Centerville, Ohio, United States, 45459
        • Suspended
        • Miami Valley Hospital South
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Cancer Center-UC Medical Center
        • Contact:
        • Principal Investigator:
          • Robert A. Franklin
      • Cincinnati, Ohio, United States, 45236
        • Recruiting
        • Oncology Hematology Care Inc-Kenwood
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Case Western Reserve University
        • Contact:
        • Principal Investigator:
          • Pedro Barata
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Shawn Dason
      • Dayton, Ohio, United States, 45415
        • Recruiting
        • Dayton Physician LLC-Miami Valley Hospital North
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Dayton, Ohio, United States, 45409
        • Suspended
        • Miami Valley Hospital
      • Dayton, Ohio, United States, 45415
        • Suspended
        • Miami Valley Hospital North
      • Findlay, Ohio, United States, 45840
        • Recruiting
        • Armes Family Cancer Center
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Findlay, Ohio, United States, 45840
        • Recruiting
        • Blanchard Valley Hospital
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Findlay, Ohio, United States, 45840
        • Recruiting
        • Orion Cancer Care
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Franklin, Ohio, United States, 45005
        • Recruiting
        • Dayton Physicians LLC-Atrium
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Franklin, Ohio, United States, 45005-1066
        • Suspended
        • Atrium Medical Center-Middletown Regional Hospital
      • Greenville, Ohio, United States, 45331
        • Recruiting
        • Dayton Physicians LLC-Wayne
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Greenville, Ohio, United States, 45331
        • Recruiting
        • Wayne Hospital
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • 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
      • Mentor, Ohio, United States, 44060
        • Recruiting
        • UH Seidman Cancer Center at Lake Health Mentor Campus
        • Contact:
        • Principal Investigator:
          • Pedro Barata
      • Springfield, Ohio, United States, 45505
        • Suspended
        • Springfield Regional Medical Center
      • Springfield, Ohio, United States, 45504
        • Suspended
        • Springfield Regional Cancer Center
      • Toledo, Ohio, United States, 43614
        • Suspended
        • University of Toledo
      • Troy, Ohio, United States, 45373
        • Suspended
        • Upper Valley Medical Center
      • Troy, Ohio, United States, 45373
        • Recruiting
        • Dayton Physicians LLC - Troy
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Warren, Ohio, United States, 44484
        • Recruiting
        • Saint Joseph Warren Hospital
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • West Chester, Ohio, United States, 45069
        • Recruiting
        • University of Cincinnati Cancer Center-West Chester
        • Contact:
        • Principal Investigator:
          • Robert A. Franklin
      • Youngstown, Ohio, United States, 44501
        • Recruiting
        • Saint Elizabeth Youngstown Hospital
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Mercy Hospital Oklahoma City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 405-752-3402
      • Oklahoma City, Oklahoma, United States, 73104
        • Suspended
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Kaiser Sunnyside Medical Center
        • Contact:
        • Principal Investigator:
          • Sandeep H. Mashru
      • Medford, Oregon, United States, 97504
        • Active, not recruiting
        • Rogue Valley Medical Center
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
        • Principal Investigator:
          • Christopher W. Ryan
      • Portland, Oregon, United States, 97227
        • Recruiting
        • Kaiser Permanente Northwest
        • Contact:
        • Principal Investigator:
          • Sandeep H. Mashru
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16601
        • Recruiting
        • UPMC Altoona
        • Principal Investigator:
          • Risa L. Wong
        • Contact:
      • Beaver, Pennsylvania, United States, 15009
        • Recruiting
        • UPMC-Heritage Valley Health System Beaver
        • Principal Investigator:
          • Risa L. Wong
        • Contact:
      • Butler, Pennsylvania, United States, 16001
        • Recruiting
        • UPMC Hillman Cancer Center at Butler Health System
        • Principal Investigator:
          • Risa L. Wong
        • Contact:
      • Erie, Pennsylvania, United States, 16505
        • Recruiting
        • UPMC Hillman Cancer Center Erie
        • Principal Investigator:
          • Risa L. Wong
        • Contact:
      • Farrell, Pennsylvania, United States, 16121
        • Recruiting
        • UPMC Cancer Center at UPMC Horizon
        • Principal Investigator:
          • Risa L. Wong
        • Contact:
      • Greensburg, Pennsylvania, United States, 15601
        • Recruiting
        • UPMC Cancer Centers - Arnold Palmer Pavilion
        • Principal Investigator:
          • Risa L. Wong
        • Contact:
          • Site Public Contact
          • Phone Number: 724-838-1900
      • Indiana, Pennsylvania, United States, 15701
        • Recruiting
        • IRMC Cancer Center
        • Principal Investigator:
          • Risa L. Wong
        • Contact:
      • Johnstown, Pennsylvania, United States, 15901
        • Recruiting
        • UPMC-Johnstown/John P. Murtha Regional Cancer Center
        • Principal Investigator:
          • Risa L. Wong
        • Contact:
          • Site Public Contact
          • Phone Number: 814-534-4724
      • McKeesport, Pennsylvania, United States, 15132
        • Recruiting
        • UPMC Cancer Center at UPMC McKeesport
        • Principal Investigator:
          • Risa L. Wong
        • Contact:
          • Site Public Contact
          • Phone Number: 412-647-8073
      • Monroeville, Pennsylvania, United States, 15146
        • Recruiting
        • UPMC Hillman Cancer Center - Monroeville
        • Principal Investigator:
          • Risa L. Wong
        • Contact:
      • Mount Pleasant, Pennsylvania, United States, 15666
        • Recruiting
        • UPMC Hillman Cancer Center - Part of Frick Hospital
        • Principal Investigator:
          • Risa L. Wong
        • Contact:
      • N. Huntingdon, Pennsylvania, United States, 15642
        • Recruiting
        • Arnold Palmer Cancer Center Medical Oncology Norwin
        • Principal Investigator:
          • Risa L. Wong
        • Contact:
      • Natrona Heights, Pennsylvania, United States, 15065
        • Recruiting
        • UPMC Cancer Center-Natrona Heights
        • Principal Investigator:
          • Risa L. Wong
        • Contact:
          • Site Public Contact
          • Phone Number: 724-230-3030
      • New Castle, Pennsylvania, United States, 16105
        • Recruiting
        • UPMC Hillman Cancer Center - New Castle
        • Principal Investigator:
          • Risa L. Wong
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburgh Cancer Institute (UPCI)
        • Principal Investigator:
          • Risa L. Wong
        • Contact:
          • Site Public Contact
          • Phone Number: 412-647-8073
      • Pittsburgh, Pennsylvania, United States, 15215
        • Recruiting
        • UPMC-Saint Margaret
        • Principal Investigator:
          • Risa L. Wong
        • Contact:
          • Site Public Contact
          • Phone Number: 412-784-4900
      • Pittsburgh, Pennsylvania, United States, 15237
        • Recruiting
        • UPMC-Passavant Hospital
        • Principal Investigator:
          • Risa L. Wong
        • Contact:
          • Site Public Contact
          • Phone Number: 412-367-6454
      • Pittsburgh, Pennsylvania, United States, 15243
        • Recruiting
        • UPMC-Saint Clair Hospital Cancer Center
        • Principal Investigator:
          • Risa L. Wong
        • Contact:
          • Site Public Contact
          • Phone Number: 412-502-3920
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC-Shadyside Hospital
        • Principal Investigator:
          • Risa L. Wong
        • Contact:
          • Site Public Contact
          • Phone Number: 412-621-2334
      • Seneca, Pennsylvania, United States, 16346
        • Recruiting
        • UPMC Cancer Center at UPMC Northwest
        • Principal Investigator:
          • Risa L. Wong
        • Contact:
          • Site Public Contact
          • Phone Number: 814-676-7900
      • Uniontown, Pennsylvania, United States, 15401
        • Recruiting
        • UPMC Cancer Center-Uniontown
        • Principal Investigator:
          • Risa L. Wong
        • Contact:
      • Washington, Pennsylvania, United States, 15301
        • Recruiting
        • UPMC Cancer Center-Washington
        • Principal Investigator:
          • Risa L. Wong
        • Contact:
      • West Mifflin, Pennsylvania, United States, 15122
        • Recruiting
        • UPMC West Mifflin-Cancer Center Jefferson
        • Principal Investigator:
          • Risa L. Wong
        • Contact:
          • Site Public Contact
          • Phone Number: 412-653-8100
    • South Carolina
      • Boiling Springs, South Carolina, United States, 29316
        • Active, not recruiting
        • Prisma Health Cancer Institute - Spartanburg
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Robert L. Grubb
        • Contact:
      • Easley, South Carolina, United States, 29640
        • Active, not recruiting
        • Prisma Health Cancer Institute - Easley
      • Greenville, South Carolina, United States, 29605
        • Active, not recruiting
        • Prisma Health Cancer Institute - Butternut
      • Greenville, South Carolina, United States, 29605
        • Active, not recruiting
        • Prisma Health Cancer Institute - Faris
      • Greenville, South Carolina, United States, 29615
        • Active, not recruiting
        • Prisma Health Cancer Institute - Eastside
      • Greenville, South Carolina, United States, 29605
        • Active, not recruiting
        • Prisma Health Greenville Memorial Hospital
      • Greer, South Carolina, United States, 29650
        • Active, not recruiting
        • Prisma Health Cancer Institute - Greer
      • Seneca, South Carolina, United States, 29672
        • Active, not recruiting
        • Prisma Health Cancer Institute - Seneca
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Contact:
        • Principal Investigator:
          • Suzanne M. Cole
      • Dallas, Texas, United States, 75237
        • Recruiting
        • UT Southwestern Simmons Cancer Center - RedBird
        • Contact:
        • Principal Investigator:
          • Suzanne M. Cole
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • UT Southwestern/Simmons Cancer Center-Fort Worth
        • Contact:
        • Principal Investigator:
          • Suzanne M. Cole
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 713-798-1354
          • Email: burton@bcm.edu
        • Principal Investigator:
          • Aihua E. Yen
      • Houston, Texas, United States, 77030
        • Recruiting
        • Ben Taub General Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 713-873-2000
        • Principal Investigator:
          • Aihua E. Yen
      • Richardson, Texas, United States, 75080
        • Recruiting
        • UT Southwestern Clinical Center at Richardson/Plano
        • Contact:
        • Principal Investigator:
          • Suzanne M. Cole
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University of Texas Health Science Center at San Antonio
        • Principal Investigator:
          • Deepak K. Pruthi
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Recruiting
        • University of Utah Sugarhouse Health Center
        • Principal Investigator:
          • Alejandro Sanchez
        • Contact:
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute/University of Utah
        • Principal Investigator:
          • Alejandro Sanchez
        • Contact:
      • Salt Lake City, Utah, United States, 84148
        • Recruiting
        • George E Wahlen Department of Veterans Affairs Medical Center
        • Principal Investigator:
          • Sumati V. Gupta
        • Contact:
          • Site Public Contact
          • Phone Number: 801-582-1565
    • Vermont
      • Saint Johnsbury, Vermont, United States, 05819
        • Recruiting
        • Norris Cotton Cancer Center-North
        • Contact:
        • Principal Investigator:
          • John D. Seigne
    • Washington
      • Bellevue, Washington, United States, 98004
        • Suspended
        • Overlake Medical Center
      • Renton, Washington, United States, 98055
        • Recruiting
        • Valley Medical Center
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Yakima, Washington, United States, 98902
        • Recruiting
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
    • Wisconsin
      • Burlington, Wisconsin, United States, 53105
        • Recruiting
        • Aurora Cancer Care-Southern Lakes VLCC
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Chippewa Falls, Wisconsin, United States, 54729
      • Eau Claire, Wisconsin, United States, 54701
      • Germantown, Wisconsin, United States, 53022
        • Recruiting
        • Aurora Health Care Germantown Health Center
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Grafton, Wisconsin, United States, 53024
        • Recruiting
        • Aurora Cancer Care-Grafton
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Green Bay, Wisconsin, United States, 54311
        • Recruiting
        • Aurora BayCare Medical Center
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Kenosha, Wisconsin, United States, 53142
        • Recruiting
        • Aurora Cancer Care-Kenosha South
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Ladysmith, Wisconsin, United States, 54848
      • Marinette, Wisconsin, United States, 54143
        • Recruiting
        • Aurora Bay Area Medical Group-Marinette
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Marshfield, Wisconsin, United States, 54449
      • Menomonee Falls, Wisconsin, United States, 53051
        • Recruiting
        • Froedtert Menomonee Falls Hospital
        • Principal Investigator:
          • Kathryn A. Bylow
        • Contact:
          • Site Public Contact
          • Phone Number: 262-257-5100
      • Milwaukee, Wisconsin, United States, 53209
        • Recruiting
        • Aurora Cancer Care-Milwaukee
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Aurora Saint Luke's Medical Center
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Principal Investigator:
          • Kathryn A. Bylow
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-3666
      • Milwaukee, Wisconsin, United States, 53233
        • Recruiting
        • Aurora Sinai Medical Center
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Minocqua, Wisconsin, United States, 54548
      • New Richmond, Wisconsin, United States, 54017
        • Recruiting
        • Cancer Center of Western Wisconsin
        • Contact:
        • Principal Investigator:
          • David M. King
      • Oak Creek, Wisconsin, United States, 53154
        • Recruiting
        • Drexel Town Square Health Center
        • Principal Investigator:
          • Kathryn A. Bylow
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-0505
      • Oshkosh, Wisconsin, United States, 54904
        • Recruiting
        • Vince Lombardi Cancer Clinic - Oshkosh
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Racine, Wisconsin, United States, 53406
        • Recruiting
        • Aurora Cancer Care-Racine
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Rice Lake, Wisconsin, United States, 54868
      • Sheboygan, Wisconsin, United States, 53081
        • Recruiting
        • Vince Lombardi Cancer Clinic-Sheboygan
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Stevens Point, Wisconsin, United States, 54482
      • Summit, Wisconsin, United States, 53066
        • Recruiting
        • Aurora Medical Center in Summit
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Two Rivers, Wisconsin, United States, 54241
        • Recruiting
        • Vince Lombardi Cancer Clinic-Two Rivers
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • Wausau, Wisconsin, United States, 54401
      • Wauwatosa, Wisconsin, United States, 53226
        • Recruiting
        • Aurora Cancer Care-Milwaukee West
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • West Allis, Wisconsin, United States, 53227
        • Recruiting
        • Aurora West Allis Medical Center
        • Contact:
        • Principal Investigator:
          • Adam P. Siegel
      • West Bend, Wisconsin, United States, 53095
        • Recruiting
        • Froedtert West Bend Hospital/Kraemer Cancer Center
        • Principal Investigator:
          • Kathryn A. Bylow
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-0505
      • Weston, Wisconsin, United States, 54476
      • Wisconsin Rapids, Wisconsin, United States, 54494

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:

  • STEP 1 REGISTRATION: Participants must have a histologically proven diagnosis of clear cell or non-clear cell renal cell carcinoma. Participants with collecting duct carcinoma histology are not eligible. Participants with multifocal or bilateral tumors are eligible
  • STEP 1 REGISTRATION: Participants must have primary tumor in place

  • STEP 1 REGISTRATION: Participants must have the following scans performed, showing clinical evidence of measurable or non-measurable metastatic disease:

    • Computed tomography (CT) scan of the chest (can be performed without contrast if CT contrast cannot be given)
    • CT of abdomen and pelvis with contrast OR magnetic resonance imaging (MRI) of the abdomen and pelvis with or without contrast

Scans must be performed within the following timeframes:

  • Treatment naive participants must have scans documenting metastatic disease completed within 90 days prior to study registration

  • Previously treated participants must have scans documenting metastatic disease completed within 90 days prior to first dose of systemic treatment

    • STEP 1 REGISTRATION: Participants with symptomatic metastases may have received palliative radiotherapy or receive palliative radiotherapy after registration
    • STEP 1 REGISTRATION: Participants must have no clear contraindications to nephrectomy
    • STEP 1 REGISTRATION: Participants must be offered the opportunity to participate in specimen bank. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System
    • STEP 1 REGISTRATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
    • STEP 1 REGISTRATION: As part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
    • STEP 2 REGISTRATION: Participants must have at least one of the following scans performed 12 weeks (+/- 2 weeks) after starting pre-randomization treatment
  • CT scan of the chest (can be performed without contrast if CT contrast cannot be given)

  • CT of abdomen and pelvis with contrast OR MRI of the abdomen and pelvis with or without contrast Scans must be performed within 28 days prior to randomization. Response should be assessed by comparing with a CT or MRI of the chest, abdomen and pelvis obtained prior to starting pre-randomization treatment. Participants with complete response in all metastatic sites are not eligible to randomize to Step 2

    • STEP 2 REGISTRATION: Participants must have one of the following objective statuses after 12 weeks of pre-randomization treatment

  • Stable disease
  • Partial response

  • The treating investigator believes the patient is deriving clinical benefit from systemic therapy AND have Zubrod performance status 0-1

    • STEP 2 REGISTRATION: Participants must plan to continue the immune-based therapy received during pre-randomization treatment
    • STEP 2 REGISTRATION: Participants must be randomized on or between the 11th and 14th week of protocol-directed pre-randomization treatment therapy
    • STEP 2 REGISTRATION: Participants must have received at least one of the minimum amounts of immunotherapy:
  • 2 infusions of nivolumab + 1 infusion of ipilimumab
  • 2 infusions of pembrolizumab

  • 2 infusions of avelumab

    • STEP 2 REGISTRATION: Participants must have a planned surgery date within 42 days of randomization
    • STEP 2 REGISTRATION: Participants must be a surgical candidate as determined by study urologist. The urology consult should be done within 42 days prior to randomization
    • STEP 2 REGISTRATION: Participants must have a complete physical examination and medical history within 28 days prior to randomization
    • STEP 2 REGISTRATION: Participants must have a Zubrod performance status of 0-1 within 28 days prior to randomization
    • STEP 2 REGISTRATION: Total bilirubin =< institutional upper limit of normal (ULN) (within 28 days prior to randomization)
    • STEP 2 REGISTRATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x institutional upper limit of normal (ULN) (within 28 days prior to randomization)
    • STEP 2 REGISTRATION: Serum creatinine =< 1.5 x the institutional upper limit of normal (IULN) OR measured OR calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault Formula) (must have been drawn and processed within 28 days prior to randomization)

Exclusion Criteria:

  • STEP 1 REGISTRATION: Participants must not have known active brain metastases. Participants with previously treated brain metastases are eligible if participant has no neurologic signs or symptoms suggestive of brain metastasis. Brain imaging studies are not required. If brain imaging studies are performed, they must be negative for disease

  • STEP 1 REGISTRATION: Participants must not have received the following prior treatment of metastatic renal cell carcinoma:

    • Treatment naive participants must not have received any prior lines of systemic therapy for metastatic renal cell carcinoma beyond the line intended as part of protocol therapy
    • Previously treated participants must not have received any systemic therapy for metastatic renal cell carcinoma beyond the one regimen received off protocol as specified in Step 1 pre-randomization treatment

  • STEP 1 REGISTRATION: Participants must not have received more than the following amounts protocol-directed pre-randomization treatment:

    • Treatment naive participants must not have received any pre-randomization treatment.

    • Previously treated participants must not be planning to receive any additional treatment prior to Step 2 randomization, and must not have received more than the following amounts of pre-randomization treatment:

      • 4 infusions of nivolumab
      • 4 infusions of ipilimumab
      • 4 infusions of pembrolizumab
      • 7 infusions of avelumab

  • STEP 1 REGISTRATION: Participants must not have received immunotherapy for any cancer within the following timeframes:

    • Treatment naive participants must not have received any immunotherapy within a year of registration
    • Previously treated participants must not have received any other immunotherapy within a year of the start of off protocol specified pre-randomization treatment
  • STEP 1 REGISTRATION: Participants must not have a solitary kidney and not have a transplanted kidney
  • STEP 1 REGISTRATION: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, any in situ or T1 cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for at least two years
  • STEP 1 REGISTRATION: Participants must not have been previously diagnosed with a medical condition that makes them ineligible for immune based combination therapy or nephrectomy
  • STEP 2 REGISTRATION: Participants must not show progression in the primary tumor. Participants who are considered to have pseudo progression are allowed
  • STEP 2 REGISTRATION: Participants must not have known active brain metastases. Participants with previously treated brain metastases are eligible if participant has no neurologic signs or symptoms suggestive of brain metastasis. Brain imaging studies are not required. If brain imaging studies are performed, they must be negative for disease
  • STEP 2 REGISTRATION: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for two years

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 1: Continued Systemic Therapy Only

Nivolumab 240 mg IV 1 q 2 weeks

OR

Nivolumab 480 mg IV 1 q 4 weeks

OR

Pembrolizumab 200 mg IV 1 q 3 weeks Axitinib 5 mg oral Daily BID

OR

Avelumab 10 mg/kg IV 1 q 2 weeks Axitinib 5 mg oral Daily BID
Procedure: Cytoreductive Nephrectomy
Radical or partial nephrectomy may be performed using laparoscopic, open, or robotic approaches. Surgery should be performed within 8 weeks of randomization
Drug: Active Comparator

Nivolumab 240 mg IV 1 q 2 weeks

OR

Nivolumab 480 mg IV 1 q 4 weeks

OR

Pembrolizumab 200 mg IV 1 q 3 weeks Axitinib 5 mg oral Daily BID

OR

Avelumab 10 mg/kg IV 1 q 2 weeks Axitinib 5 mg oral Daily BID
Experimental: Arm 2: Nephrectomy and Continued Systemic Therapy

Continued systemic therapy as above, plus:

Radical or partial nephrectomy may be performed using laparoscopic, open, or robotic approaches. Surgery should be performed within 8 weeks of randomization.
Procedure: Cytoreductive Nephrectomy
Radical or partial nephrectomy may be performed using laparoscopic, open, or robotic approaches. Surgery should be performed within 8 weeks of randomization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From date of randomization to date of death due to any cause, assessed up to 7 years.
Analysis will be intent-to-treat. Evidence suggesting early termination of the trial and a conclusion that the cytoreductive nephrectomy (CN) approach is superior to treatment alone would be if the null hypothesis is rejected at the one-sided 0.005 level. For the second and third interim analyses, the null and alternative hypotheses with respect to survival will be tested, with superiority tested at the one-sided 0.005 level, and futility determined to be met if the (CN versus no CN) hazard ratio is greater than or equal to 1. A proportional hazards model will be fit to estimate the hazard ratio adjusting for the stratification factors as covariates in the model. Will evaluate whether each of the stratification factors are predictive factors of cytoreductive nephrectomy by placing an interaction term corresponding to each stratification factor and treatment arm in the proportional hazards survival model.
From date of randomization to date of death due to any cause, assessed up to 7 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival in subset who received assigned protocol treatment
Time Frame: From date of randomization to date of death due to any cause, assessed up to 7 years
Will be included in the proportional hazards regression model adjusting for stratification factors as covariates.
From date of randomization to date of death due to any cause, assessed up to 7 years
Progression-free survival
Time Frame: From date of randomization to date of first documentation of progression, or death due to any cause, assessed up to 7 years
A proportional hazards model will be used to compare progression-free survival between arms, adjusting for the stratification factors as covariates.
From date of randomization to date of first documentation of progression, or death due to any cause, assessed up to 7 years
Objective response
Time Frame: Up to 7 years
Objective response includes all confirmed and unconfirmed partial and complete responses. Baseline will be disease assessment at randomization. Response Evaluation Criteria in Solid Tumors response rates will be evaluated, excluding the primary tumor in the kidney because that disease will be removed in half the participant's post-randomization. Comparison of response rates will be performed using logistic regression with stratification factors as covariates and an indicator for treatment arm.
Up to 7 years
Change in maximum diameter of primary tumor
Time Frame: From the disease assessment just prior to the start of immunotherapy to the week 12 disease assessment
Descriptive statistics will be provided including stratified results by treatment regimen received. Potential additional analyses may include assessment of the interaction between change in primary tumor and randomized treatment arm. This will be modeled as an interaction term in the proportional hazards survival model.
From the disease assessment just prior to the start of immunotherapy to the week 12 disease assessment

Collaborators and Investigators

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

Sponsor

SWOG Cancer Research Network

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 8, 2021

Primary Completion (Estimated)

July 1, 2033

Study Completion (Estimated)

July 1, 2033

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 10, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S1931
  • NCI-2020-04442 (Other Identifier: NCI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Metastatic Renal Cell Carcinoma

Clinical Trials on Cytoreductive Nephrectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe