Spots Global Cancer Trial Database for Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients

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Trial Identification

Brief Title: Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients

Official Title: A Phase 2 Feasibility Study Combining Pembrolizumab and Metformin to Harness the Natural Killer Cytotoxic Response in Metastatic Head and Neck Cancer Patients

Study ID: NCT04414540

Conditions

Head and Neck Squamous Cell Carcinoma

Interventions

Metformin Extended Release Oral Tablet

Pembrolizumab

Study Description

Brief Summary: The purpose of this study is to determine anti-tumor activity by measuring overall response rate in recurrent and/or metastatic HNSCC patients receiving the combination of metformin and pembrolizumab.

Detailed Description: Recurrent and/or metastatic HNSCC patients will be treated with combination of metformin and pembrolizumab. Patients will be randomized into arms 1 and 2, to either receive Metformin prior to pembrolizumab or to begin Metformin after pembrolizumab treatment begins. The patients are randomized for the exploratory endpoints in order to better understand the difference of effects of metformin versus pembrolizumab on the immune system although efficacy is based on combination.