Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients

NCT04414540 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: UCCC-HN-19-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Response by RECIST 1.1 and iRECIST

  To determine anti-tumor activity by measuring overall response rate by RECIST 1.1 and iRECIST in recurrent and/or metastatic HNSCC patients receiving the combination of metformin and pembrolizumab.

  2 years

Secondary Outcomes (3)

• Number of patients with adverse events measured by CTCAE v5.0

  2 years

• Progression Free Survival (PFS)

  1 year

• Overall Survival (OS)

  1 year

Other Outcomes (6)

• Percentage of peripheral blood immune cell populations determined by flow cytometry

  4 weeks

• Percent tumor infiltrating NK cells determined by immunofluorescence

  4 weeks

• Cytokine levels including IL-2, IL-4, IL-6, IL-8, IL-10, INFgamma, TNFalpha in Plasma via ELISA based technology.

  4 weeks

Study Arms (2)

Arm 1: Metformin before Pembrolizumab

EXPERIMENTAL

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.

Drug: Metformin Extended Release Oral Tablet; Drug: Pembrolizumab

Arm 2: Metformin after Pembrolizumab

EXPERIMENTAL

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

Drug: Metformin Extended Release Oral Tablet; Drug: Pembrolizumab

Interventions

Metformin Extended Release Oral Tablet DRUG

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

Also known as: Glucophage XR

Arm 1: Metformin before Pembrolizumab; Arm 2: Metformin after Pembrolizumab

Pembrolizumab DRUG

Pembrolizumab q 3 weeks

Also known as: Keytruda

Arm 1: Metformin before Pembrolizumab; Arm 2: Metformin after Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trisha Wise-Draper: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Metformin; pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Trisha Wise-Draper, MD, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will be on one of two arms that will be studied in parallel.

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: June 4, 2020
• Study Start: August 31, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)