Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy

Conditions

• 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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nephrectomy — PROCEDURE
  Undergo nephrectomy
• Nivolumab — BIOLOGICAL
  Given IV
• Patient Observation — OTHER
  Undergo observation
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

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 Dates

Start date

Apr 28, 2017

Status verified

Jan 2026

Primary completion

May 24, 2023

Completion

Jun 9, 2031

Study Design

Enrollment

819 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (nivolumab + nephrectomy)
  Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 2 cycles. Patients then undergo partial or radical nephrectomy 7-28 days later. Patients then receive nivolumab over 30 IV on day 1. Treatment repeats every 14 days for 6 cycles, and then every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients enrolled after Amendment 4 receive nivolumab IV over 30 minutes on day 1. Patients then undergo partial or radical nephrectomy 7-28 days later. Patient then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 4 weeks for up to 9 cycles in the absence of disease progression or unacceptable toxicity.
• Active Comparator: Arm B (nephrectomy only)
  Patients undergo partial or radical nephrectomy within 8 weeks after registration followed by observation.

Primary Outcome Measure

Recurrence-free Survival (RFS) Rate at 5 Years [ Time Frame: Assessed at 20 weeks, 40 weeks, then every 3 months for patients <2 years from randomization, then every 6 months for 3 years ]

Locations (396)

Related coverage on Hipa.ai

• Nivolumab Phase 3 in Localized Kidney Cancer: No Significant RFS or OS…
  Nivolumab · May 24, 2023 · ClinicalTrials.gov

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