Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients

• Status: Recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trisha Wise-Draper
• Collaborator: American Cancer Society, Inc.
• Treatments: Metformin; Pembrolizumab

Criteria

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