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

StatusActive, Not Recruiting
PhasePhase 2
Started2025-03-20
View on ClinicalTrials.gov ↗
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.

Amendment history 3 changes detected by DataLookout

2026-09-12
Enrollment closed, study ongoing
2026-09-12
Final enrollment: 52 participants (planned 15)
2026-09-12
Primary completion pushed: 2026-12-15 → 2028-12-15
Trial Details
NCT Number NCT06708949
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: Bristol-Myers Squibb
Conditions Renal Cell Carcinoma, Clear Cell
Enrollment 52 participants
Start Date 2025-03-20
Primary Completion 2028-12-15 (estimated)
Study Completion 2028-12-15 (estimated)
Updated on ClinicalTrials.gov 2026-09-11