NCT04552223

Nivolumab Plus Relatlimab in Patients With Metastatic Uveal Melanoma

A Phase 2 Study of Nivolumab + BMS-986016 (Relatlimab) in Patients With Metastatic Uveal Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Jose Lutzky, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to test if a combination treatment of nivolumab and relatlimab will result in tumor reduction in patients with metastatic uveal melanoma.

Detailed description

This is a phase II single-institution trial with a Simon two-stage minimax design with 27 patients (13 in stage 1, 14 in stage 2) setting a 5% type I error and 80% power under true objective response rate (ORR) of 20%. The null hypothesis (ORR=5%) is rejected if 4 or more responses are observed in 27 patients. No prior PD-1, CTLA-4 and/or LAG-3 blocking antibody treatment was allowed. We will also perform single-cell mRNA and T-cell receptor (TCR) variable, diversity, and joining (V\[D\]J) sequencing pre-treatment and at either progression or response. Patients will be treated with nivolumab 480 mg/relatlimab 160 mg IV q4wks to progression or intolerable toxicity for up to two years.

Conditions

• Metastatic Uveal Melanoma

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab 480mg administered intravenously on Day 1 of each 4 week cycle.
DRUG	Relatlimab	Relatlimab 160 mg administered intravenously on Day 1 of each 4 week cycle.

Timeline

• Start date: 2020-11-10
• Primary completion: 2024-01-04
• Completion: 2026-01-04
• First posted: 2020-09-17
• Last updated: 2026-02-11
• Results posted: 2025-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study