An Immuno-therapy Study of Nivolumab in Combination With Experimental Medication BMS-986205 Compared to Standard of Care EXTREME Regimen in First-line Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck

Official Title

A Randomized, Global, Open-label Study of Nivolumab in Combination With BMS-986205 vs Standard of Care EXTREME Regimen in First-line Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck

Summary:

This is a study of Nivolumab in combination with experimental medication BMS-986205 compared to the standard of care EXTREME regimen in head and neck cancer that has come back after initial treatment, or is widespread when first diagnosed.

Trial Description

Primary Outcome:

• Progression-free survival (PFS) as determined by Blinded Independent Central Review (BICR) using RECIST 1.1
• Overall survival (OS)
• Objective response rate (ORR) determined by BICR using RECIST 1.1

• Number of adverse events (AE)
• Number of serious adverse events (SAE)
• Time to meaningful symptomatic deterioration (TTSD)

View this trial on ClinicalTrials.gov