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Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients

NCT ID: NCT04414540

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-31

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Head and Neck Squamous Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be on one of two arms that will be studied in parallel.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1: Metformin before Pembrolizumab

Metformin ER 1000mg daily D-14 to D-7. Metformin ER 2000mg daily D-7 to D1. D1 Begin Pembrolizumab 200mg every 3 weeks, while continuing Metformin ER 2000mg daily.

Group Type EXPERIMENTAL

Metformin Extended Release Oral Tablet

Intervention Type DRUG

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

Pembrolizumab

Intervention Type DRUG

Pembrolizumab q 3 weeks

Arm 2: Metformin after Pembrolizumab

D-21 Begin Pembrolizumab 200mg. D-7 begin Metformin ER 1000mg daily. D1 begin Metformin ER 2000mg daily. Continue Pembrolizumab 200mg every 3 weeks.

Group Type EXPERIMENTAL

Metformin Extended Release Oral Tablet

Intervention Type DRUG

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

Pembrolizumab

Intervention Type DRUG

Pembrolizumab q 3 weeks

Interventions

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Metformin Extended Release Oral Tablet

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

Intervention Type DRUG

Pembrolizumab

Pembrolizumab q 3 weeks

Intervention Type DRUG

Other Intervention Names

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Glucophage XR Keytruda

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

Trisha Wise-Draper

OTHER

Sponsor Role lead

Responsible Party

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Trisha Wise-Draper

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Trisha Wise-Draper, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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UCCC-HN-19-01

Identifier Type: -

Identifier Source: org_study_id