OncoMatch/Clinical Trials/NCT04510597
Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove the Kidney in Metastatic Kidney Cancer, the PROBE Trial
Is NCT04510597 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Active Comparator for metastatic clear cell renal cell carcinoma.
Treatment: Active Comparator — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ZUBROD 0–1
Prior therapy
Cannot have received: systemic therapy
Exception: 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
Participants must not have received the following prior treatment of metastatic renal cell carcinoma
Cannot have received: immunotherapy
Exception: 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
Participants must not have received immunotherapy for any cancer within the following timeframes
Cannot have received: protocol-directed pre-randomization treatment (nivolumab, ipilimumab, pembrolizumab, avelumab)
Exception: 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
Participants must not have received more than the following amounts protocol-directed pre-randomization treatment
Lab requirements
Kidney function
Serum creatinine ≤ 1.5 x institutional ULN OR measured OR calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault Formula (within 28 days prior to randomization)
Liver function
Total bilirubin ≤ institutional upper limit of normal (ULN); AST/ALT ≤ 3 x institutional ULN (within 28 days prior to randomization)
Total bilirubin ≤ institutional upper limit of normal (ULN) (within 28 days prior to randomization); AST/ALT ≤ 3 x institutional upper limit of normal (ULN) (within 28 days prior to randomization); 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)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham Cancer Center · Birmingham, Alabama
- Banner MD Anderson Cancer Center · Gilbert, Arizona
- Kingman Regional Medical Center · Kingman, Arizona
- Banner University Medical Center - Tucson · Tucson, Arizona
- University of Arizona Cancer Center-North Campus · Tucson, Arizona
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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