Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy

Running, not enrolling · Phase 3

Conditions studied: Metastatic Renal Cell Carcinoma, Sarcomatoid Renal Cell Carcinoma, Stage II Renal Cell Cancer AJCC v7, Stage III Renal Cell Cancer AJCC v7, Unclassified Renal Cell Carcinoma

In brief

This phase III trial compares nephrectomy (surgery to remove a kidney or part of a kidney) with nivolumab to the usual approach of nephrectomy followed by standard post-operative follow-up and monitoring, in treating patients with kidney cancer that is limited to a certain part of the body (localized). Nivolumab is a drug that may help stimulate the immune system to attack any cancer cells that may remain after surgery. The addition of nivolumab to the usual surgery could prevent the cancer from returning. It is not yet known whether nivolumab and nephrectomy is more effective than nephrectomy alone in treating patients with kidney cancer.

Key facts

Study ID

NCT03055013

Run by

National Cancer Institute (NCI)

People needed

819

Starts

2017-04-28

Expected to finish

2031-06-09

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ELIGIBILITY CRITERIA FOR RANDOMIZATION:
• 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
• 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)
• Liver, bone, or brain metastases are not permitted
• 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
• 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
• 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
• 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
• 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
• 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
• Patient must not have any prior systemic or local anti-cancer therapy for the current RCC
• Patient must not have undergone a partial nephrectomy for the current RCC
• Patient must not have had a metastasectomy for the current RCC diagnosis unless performed to render patient NED (in addition to the planned nephrectomy) within 6 months prior to the current diagnosis
• Patient must not have received current or past antineoplastic systemic therapies for RCC: i.e., chemotherapy, hormonal therapy, immunotherapy, or standard or investigational agents for treatment of RCC
• Patient must not have received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
• Patient must be >= 18 years of age. Because no dosing or adverse event data are currently available on the use of nivolumab therapy in patients < 18 years of age, children are excluded from this study
• Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Patient must not have a prior history of RCC that was treated with curative intent within the past 5 years
• Patients with a prior RCC that was treated > 5 years before, are eligible if the current tumor is consistent with a new primary in the opinion of the treating investigator
• Patients with bilateral synchronous RCCs are eligible if they can be resected or definitively treated at the same time or within a 12 week window from time of initial nephrectomy (partial or radical) or procedure and maintain adequate residual renal function; the patient is not eligible if both kidneys are to be completely removed and subsequent hemodialysis will be required
• Permitted forms of local therapy for second tumor:
• Partial or radical nephrectomy
• If kidney tumor is =< 3 cm: thermal ablation (e.g., radiofrequency ablation, cryoablation or stereotactic radiosurgery)
• Patients cannot have concurrent malignancies, with the following exceptions:
• Adequately treated basal cell or squamous cell skin cancer

Where it is running

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

Full record on ClinicalTrials.gov

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