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Study identifier: NCT04510597 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Metastatic Clear Cell Renal Cell Carcinoma · Metastatic Renal Cell Carcinoma · Stage IV Renal Cell Cancer AJCC v8  ·  Sponsor: SWOG Cancer Research Network

PhasePhase 3
Planned participants364
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Megan Keim, MS  ·  210-614-8808  ·  mkeim@swog.org

Dana Sparks, MAT  ·  210-614-8808  ·  dsparks@swog.org

Always discuss trial participation with your own doctor first.

Locations (387)

University of Alabama at Birmingham Cancer CenterBirmingham, Alabama, United StatesRecruiting
Banner MD Anderson Cancer CenterGilbert, Arizona, United StatesRecruiting
Kingman Regional Medical CenterKingman, Arizona, United StatesRecruiting
Banner University Medical Center - TucsonTucson, Arizona, United StatesRecruiting
University of Arizona Cancer Center-North CampusTucson, Arizona, United StatesRecruiting
Mercy Hospital Fort SmithFort Smith, Arkansas, United StatesRecruiting
PCR OncologyArroyo Grande, California, United StatesRecruiting
Sutter Auburn Faith HospitalAuburn, California, United StatesRecruiting
Sutter Cancer Centers Radiation Oncology Services-AuburnAuburn, California, United StatesRecruiting
Alta Bates Summit Medical Center-Herrick CampusBerkeley, California, United StatesRecruiting
Keck Medicine of USC Buena ParkBuena Park, California, United StatesRecruiting
Sutter Cancer Centers Radiation Oncology Services-Cameron ParkCameron Park, California, United StatesRecruiting

+ 375 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT04510597