NRG-HN011

A Randomized Phase II Study of Nivolumab Versus Nivolumab and BMS-986016 (Relatlimab) as Maintenance Treatment After First-Line Treatment with Platinum-Gemcitabine-Nivolumab for Patients with Epstein-Barr Virus-Associated Recurrent/Metastatic Nasopharyngeal Carcinoma (REMAIN)

Principal Investigator

Brigette Ma, MD

Status

Disease Site

Head and Neck [HN] Head and Neck

Phase

II

Developmental Therapeutics

No

Primary Objective

To determine if adding BMS-986016 (relatlimab) to nivolumab
maintenance therapy shows a signal of improved progression-free survival (PFS)
according to RECIST 1.1 in patients who do not progress following treatment
with platinum-gemcitabine-nivolumab combination in the first-line treatment of
recurrent and/or metastatic nasopharyngeal carcinoma (R/M NPC).

Patient Population

Pathologically (histologically or cytologically) proven
diagnosis of nasopharyngeal carcinoma (NPC) that has recurred locoregionally
and/or is present at distant sites.

Target Accrual

156