NCT06708949

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Primary Objectives: To determine the safety and tolerability of nivolumab, relatlimab and ipilimumab in patients with untreated advanced RCC • To assess the ORR of nivolumab, relatlimab and ipilimumab in patients with untreated advanced RCC

Conditions

• Renal Cell Carcinoma, Clear Cell

Interventions

Type	Name	Description
DRUG	Drugs Nivolumab	Given by IV Infusion
DRUG	Ipilimumab	Given by IV Infusion
DRUG	BMS-986213 (Relatlimab-Nivolumab FDC)	Given by IV Infusion

Timeline

• Start date: 2025-03-20
• Primary completion: 2026-12-15
• Completion: 2028-12-15
• First posted: 2024-11-29
• Last updated: 2026-03-13

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study