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Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients

NCT04414540 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-05-08

Study results available
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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.

Conditions

Interventions

DRUG

Metformin Extended Release Oral Tablet

Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily

DRUG

Pembrolizumab

Pembrolizumab q 3 weeks

Sponsors & Collaborators

  • American Cancer Society, Inc.

    collaborator OTHER

  • Trisha Wise-Draper

    lead OTHER

Principal Investigators

  • Trisha Wise-Draper, MD, PhD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-31
Primary Completion
2026-02-02
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04414540 on ClinicalTrials.gov