Nivolumab Plus Relatlimab in Patients With Metastatic Uveal Melanoma

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04552223
Study type	Interventional
Source	University of Miami
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	November 10, 2020
Completion date	December 2026

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See also
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