Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy (NCT03055013)

Check 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).

1. ELIGIBILITY CRITERIA FOR RANDOMIZATION:
2. Patients must have a renal mass consistent with a clinical stage \>= T2Nx renal cell carcinoma (RCC) or TanyN+ RCC for which radical or partial nephrectomy is planned
3. Patients must have no clinical or radiological evidence of distant metastases (M0) unless the presumed M1 disease is planned to be resected/definitively treated (e.g., thermal ablation, stereotactic radiation) at the same time or up to 12 weeks after the date of the initial procedure such that the patient is considered "no evidence of disease" (M1 NED)
4. Liver, bone, or brain metastases are not permitted
5. No more than 3 metastases are permitted, and all must be able to be removed or definitively treated within 12 weeks of the primary tumor resection
6. If histological confirmation of RCC has not been done within 12 months prior to randomization, patient must be willing to undergo a core biopsy for this purpose if randomized to Arm A
7. NOTE: This histologic confirmation can be a (1) standard of care diagnostic biopsy or (2) a research biopsy or a planned metastasectomy. Tissue must be obtained with results available prior to the neoadjuvant dose
8. Patients randomized to Arm A: core tumor biopsy must have demonstrated RCC of any histology, including sarcomatoid, unclassified, or "unknown histology" (if preoperative biopsy was uninformative) with exception below for non-diagnostic biopsies
9. If the biopsy performed following randomization clearly demonstrates a benign condition, oncocytoma or a different type of cancer that is not RCC, the patient is not eligible and must come off study
10. A non-diagnostic biopsy is considered a good faith effort and does not need to be repeated unless deemed clinically necessary by the treating investigator
11. Patient must not have any prior systemic or local anti-cancer therapy for the current RCC
12. Patient must not have undergone a partial nephrectomy for the current RCC

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (413 Sites)

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
• Veterans Administration Medical Center - Birmingham — Birmingham, Alabama
• Banner MD Anderson Cancer Center — Gilbert, Arizona
• Cancer Center at Saint Joseph's — Phoenix, Arizona
• Banner University Medical Center - Tucson — Tucson, Arizona
• University of Arizona Cancer Center-North Campus — Tucson, Arizona
• Kaiser Permanente-Anaheim — Anaheim, California
• Sutter Auburn Faith Hospital — Auburn, California
• AIS Cancer Center at San Joaquin Community Hospital — Bakersfield, California
• Kaiser Permanente-Baldwin Park — Baldwin Park, California
• Kaiser Permanente-Bellflower — Bellflower, California
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California
• Mills-Peninsula Medical Center — Burlingame, California
• Community Cancer Institute — Clovis, California
• City of Hope Comprehensive Cancer Center — Duarte, California
• Kaiser Permanente-Fontana — Fontana, California
• Kaiser Permanente South Bay — Harbor City, California
• Kaiser Permanente-Irvine — Irvine, California
• UC San Diego Moores Cancer Center — La Jolla, California
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California
• USC / Norris Comprehensive Cancer Center — Los Angeles, California
• Kaiser Permanente West Los Angeles — Los Angeles, California
• Cedars-Sinai Medical Center — Los Angeles, California
• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California
• Fremont - Rideout Cancer Center — Marysville, 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.