A Randomized Phase 2 Trial of Nivolumab, Relatlimab Plus Ipilimumab vs. Nivolumab Plus Ipilimumab in First-line Advanced Renal Cell Carcinoma (RCC)

This is a phase 2 stratified, randomized, multicenter, study investigating the efficacy of a triplet arm treating with nivolumab 480 mg every 4 weeks (Q4W), relatlimab 160 mg Q4W and ipilimumab 1 mg/kg every 8 weeks (Q8W) intravenous (IV) versus a doublet arm treating with nivolumab 480 mg Q3W and ipilimumab 1mg/kg Q3W IV in first-line advanced RCC.

Trial Details

NCT ID
NCT06708949
Phase
PHASE2
Sponsor
M.D. Anderson Cancer Center
Status
RECRUITING
Cancer Type
Kidney Cancer
Interventions
  • Drugs Nivolumab
  • Ipilimumab
  • BMS-986213 (Relatlimab-Nivolumab FDC)
Locations (sample)
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Durham, North Carolina, United States|35.99403,-78.89862
  • Philadelphia, Pennsylvania, United States|39.95238,-75.16362
  • Nashville, Tennessee, United States|36.16589,-86.78444
  • Dallas, Texas, United States|32.78306,-96.80667

Key Eligibility Criteria

  • Willing and able to provide a signed and dated written informed consent.
  • ≥ 18 years of age
  • Confirmed diagnosis of RCC with a clear cell component
  • Stage IV metastatic renal cell carcinoma per American Joint Committee on Cancer

For full eligibility, visit ClinicalTrials.gov.

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