Nivolumab Plus Pemetrexed for Head and Neck Squamous Cell Carcinoma

Official Title

A Study to Evaluate the Safety and Feasibility of the Combined Use of Nivolumab With Pemetrexed for the Treatment of Advanced Squamous Cell Carcinoma of the Head and Neck

Summary:

The purpose of this study is to find out what effects the combination of Nivolumab and Pemetrexed has on you and your cancer. The safety of this combination and the effectiveness of this treatment will be studied.

Trial Description

Primary Outcome:

• Feasibility
• Safety/tolerability (incidence of adverse events including immune related)

Secondary Outcome:

• Response Rate
• Progression free survival
• Overall Survival
• Patient reported quality of life

The treatment of patients with SCCHN is challenging, and represents an area of high unmet need. Treatment options within this patient population are limited, and inadequately treated disease may cause high morbidity, negatively impacting quality of life and leading to increased costs for supportive care. To address the unmet needs of these patients, this exploratory trial combining pemetrexed with standard-of-care nivolumab, with an investigational plan to study clinical and health services outcomes is being proposed.

View this trial on ClinicalTrials.gov