Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients

Last updated: December 17, 2025
Sponsor: Trisha Wise-Draper
Overall Status: Active - Not Recruiting

Phase

2

Condition

Head And Neck Cancer

Squamous Cell Carcinoma

Treatment

Pembrolizumab

Metformin Extended Release Oral Tablet

Clinical Study ID

NCT04414540
UCCC-HN-19-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed recurrent or metastatic non-cutaneousHNSCC for which there are no surgical or radiation curative options.

  • Patients may have received up to 3 prior lines of therapy for metastatic orrecurrent disease.

  • ECOG performance status ≤2

Exclusion

Exclusion Criteria:

  • Patients with nasopharyngeal HNSCC will be excluded

  • Patients who have had chemotherapy or radiotherapy within 2 weeks prior to enteringthe 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 formetastatic/recurrent disease

  • Patients currently receiving metformin or who have received metformin in the last 6months

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Pembrolizumab
Phase: 2
Study Start date:
August 31, 2020
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University of Cincinnati Medical Center

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Site Not Available

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