Study on Combining Pembrolizumab and Metformin for Patients with Advanced Head and Neck Cancer

Sponsor: Trisha Wise-Draper

Sponsor score: 0

ClinicalTrials ID:NCT04414540

Provider View

This clinical trial is testing a new treatment approach using a combination of pembrolizumab and metformin to see if it can help control advanced head and neck cancer that has returned or spread.

Patient Parameters

Program Overview

The aim of this study is to find out if combining two drugs, pembrolizumab and metformin, can effectively treat head and neck cancer that has come back or spread to other parts of the body. Researchers will measure how well the cancer responds to this treatment combination.

Description

In this study, patients with advanced head and neck cancer will receive a combination of two drugs: metformin and pembrolizumab. Participants will be divided into two groups. One group will start taking metformin before pembrolizumab, while the other group will begin metformin after starting pembrolizumab. This setup helps researchers understand how each drug affects the immune system, although the main focus is on how well the combination works against cancer.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced head and neck cancer that cannot be treated with surgery or radiation.
  • May have received up to three previous treatments for advanced cancer.
  • Be in relatively good health, with a performance status score of 2 or less, meaning able to carry out light work or activities.

Exclusion Criteria

  • Have a type of head and neck cancer called nasopharyngeal cancer.
  • Have had chemotherapy or radiation within two weeks before joining the study.
  • Have not fully recovered from side effects of previous cancer treatments.
  • Have previously been treated with PD-1 or PD-L1 inhibitors for advanced cancer.
  • Are currently taking metformin or have taken it in the past six months.

Locations

FACILITYZIPCITYSTATE
University of Cincinnati Medical Center45219CincinnatiOhio

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