Spots Global Cancer Trial Database for Nivolumab Plus Relatlimab in Patients With Metastatic Uveal Melanoma

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Trial Identification

Brief Title: Nivolumab Plus Relatlimab in Patients With Metastatic Uveal Melanoma

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

Study ID: NCT04552223

Conditions

Metastatic Uveal Melanoma

Interventions

Nivolumab

Relatlimab

Study Description

Brief 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.