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

Conditions

• Renal Cell Carcinoma, Clear Cell

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Drugs Nivolumab — DRUG
  Given by IV Infusion
• Ipilimumab — DRUG
  Given by IV Infusion
• BMS-986213 (Relatlimab-Nivolumab FDC) — DRUG
  Given by IV Infusion

Study Details

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.

Key Dates

First listed

Nov 29, 2024

Start date

Mar 20, 2025

Status verified

Sep 2026

Primary completion

Dec 15, 2028

Completion

Dec 15, 2028

Study Design

Enrollment

52 participants (actual)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment with Nivolumab + Ipilimumab
  Participants will randonmized to study and treatment will be administered on an outpatient basis.
• Experimental: Treatment with Nivolumab + Relatlimab + Ipilimumab
  Participants will randonmized to study and treatment will be administered on an outpatient basis.

Primary Outcome Measure

Safety and Averse events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Locations (6)

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