Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove the Kidney in Metastatic Kidney Cancer, the PROBE Trial (NCT04510597)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (32 items) and avoid the listed exclusions (21 items).
Location: University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (387 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
- Mercy Hospital Fort Smith — Fort Smith, Arkansas
- PCR Oncology — Arroyo Grande, California
- Sutter Auburn Faith Hospital — Auburn, California
- Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California
- Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California
- Keck Medicine of USC Buena Park — Buena Park, California
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park, California
- Eden Hospital Medical Center — Castro Valley, California
- Sutter Davis Hospital — Davis, California
- City of Hope Comprehensive Cancer Center — Duarte, California
- Palo Alto Medical Foundation-Fremont — Fremont, California
- Keck Medicine of USC Huntington Beach — Huntington Beach, California
- Keck Medicine of USC Koreatown — Los Angeles, California
- Los Angeles County-USC Medical Center — Los Angeles, California
- USC / Norris Comprehensive Cancer Center — Los Angeles, California
- Cedars Sinai Medical Center — Los Angeles, California
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California
- Memorial Medical Center — Modesto, California
- Palo Alto Medical Foundation-Camino Division — Mountain View, California
- Palo Alto Medical Foundation-Gynecologic Oncology — Mountain View, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.