Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients

NCT04414540 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 1 other identifier: UCCC-HN-19-01
• Study Type: interventional
• Target: 21
• 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 Rate by RECIST 1.1 and iRECIST

  A complete response is defined as the disappearance of all target lesions, with any affected lymph nodes reduced to less than 10 mm. A partial response occurs when there is at least a 30% reduction in the total size of target lesions compared with baseline. Progressive disease is indicated by at least a 20% increase in lesion size (with a minimum absolute increase of 5 mm) or the appearance of new lesions. Stable disease describes cases where tumor size changes do not meet criteria for partial response or progressive disease.

  Up to 2 years after completion of study treatment

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

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

Results Point of Contact

• Title: Trisha Wise-Draper, MD PHD
• Organization: University of Cincinnati

wiseth@ucmail.uc.edu

(513) 558-2826

Study Officials

• Trisha Wise-Draper, MD, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: February 2, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 8, 2026
• Results First Posted: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)