Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients

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

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.

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.

Inclusion Criteria:

• Histologically or cytologically confirmed recurrent or metastatic non-cutaneous HNSCC for which there are no surgical or radiation curative options.
• Patients may have received up to 3 prior lines of therapy for metastatic or recurrent disease.
• ECOG performance status ≤2

Exclusion Criteria:

• Patients with nasopharyngeal HNSCC will be excluded
• Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study.
• Patients who have not recovered from adverse events due to prior anti-cancer therapy
• Patients who have previously received PD-1 or PD-L1 inhibitors for metastatic/recurrent disease
• Patients currently receiving metformin or who have received metformin in the last 6 months