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Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove the Kidney in Metastatic Kidney Cancer, the PROBE Trial
Sponsor: SWOG Cancer Research Network
Summary
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.
Official title: Phase III Trial of Immunotherapy-Based Combination Therapy With or Without Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma (PROBE Trial)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
364
Start Date
2021-03-08
Completion Date
2033-07
Last Updated
2026-10-08
Healthy Volunteers
No
Conditions
Interventions
Cytoreductive Nephrectomy
Radical or partial nephrectomy may be performed using laparoscopic, open, or robotic approaches. Surgery should be performed within 8 weeks of randomization
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
Locations (387)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Kingman Regional Medical Center
Kingman, Arizona, United States
Banner University Medical Center - Tucson
Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
PCR Oncology
Arroyo Grande, California, United States
Sutter Auburn Faith Hospital
Auburn, California, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
Keck Medicine of USC Buena Park
Buena Park, California, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States
Eden Hospital Medical Center
Castro Valley, California, United States
Sutter Davis Hospital
Davis, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Palo Alto Medical Foundation-Fremont
Fremont, California, United States
Keck Medicine of USC Huntington Beach
Huntington Beach, California, United States
Keck Medicine of USC Koreatown
Los Angeles, California, United States
Los Angeles County-USC Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Memorial Medical Center
Modesto, California, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, United States
Sutter Cancer Research Consortium
Novato, California, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States
Keck Medical Center of USC Pasadena
Pasadena, California, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, United States
Sutter Roseville Medical Center
Roseville, California, United States
Sutter Medical Center Sacramento
Sacramento, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States
Mills Health Center
San Mateo, California, United States
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, United States
Sutter Pacific Medical Foundation
Santa Rosa, California, United States
City of Hope South Pasadena
South Pasadena, California, United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, United States
Cedars-Sinai Cancer - Tarzana
Tarzana, California, United States
City of Hope Upland
Upland, California, United States
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
AdventHealth Altamonte
Altamonte Springs, Florida, United States
AdventHealth Celebration
Celebration, Florida, United States
AdventHealth Kissimmee
Kissimmee, Florida, United States
AdventHealth Medical Group Urology at Orlando
Orlando, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
AdventHealth East Orlando
Orlando, Florida, United States
AdventHealth Winter Park
Winter Park, Florida, United States
Saint Anthony's Health
Alton, Illinois, United States
Rush - Copley Medical Center
Aurora, Illinois, United States
Advocate Good Shepherd Hospital
Barrington, Illinois, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Loyola Center for Health at Burr Ridge
Burr Ridge, Illinois, United States
Illinois CancerCare-Canton
Canton, Illinois, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, United States
SIH Cancer Institute
Carterville, Illinois, United States
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Centralia Oncology Clinic
Centralia, Illinois, United States
Saint Mary's Hospital
Centralia, Illinois, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, United States
Carle at The Riverfront
Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States
Illinois CancerCare-Dixon
Dixon, Illinois, United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, United States
Carle Physician Group-Effingham
Effingham, Illinois, United States
Crossroads Cancer Center
Effingham, Illinois, United States
Advocate Sherman Hospital
Elgin, Illinois, United States
Elmhurst Memorial Hospital
Elmhurst, Illinois, United States
Illinois CancerCare-Eureka
Eureka, Illinois, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States
Advocate South Suburban Hospital
Hazel Crest, Illinois, United States
Loyola Medicine Homer Glen
Homer Glen, Illinois, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, United States
AMG Libertyville - Oncology
Libertyville, Illinois, United States
Condell Memorial Hospital
Libertyville, Illinois, United States
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Melrose Park, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Edward Hospital/Cancer Center
Naperville, Illinois, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States