Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT04510597
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

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

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

And 287 more locations on ClinicalTrials.gov