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Could a diabetes drug boost cancer immunotherapy?

NCT ID NCT04414540

Disease control Sponsor: Trisha Wise-Draper Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether adding metformin, a common diabetes drug, to the immunotherapy pembrolizumab (Keytruda) can help shrink tumors in people with metastatic head and neck cancer. The study enrolls 21 adults whose cancer has spread or returned and cannot be treated with surgery or radiation. Researchers will measure how many patients respond to the combination and track any side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pembrolizumab (Keytruda) and metformin (Glucophage XR)
What this could lead to
If this combination works, it could offer a new treatment option for people with advanced head and neck cancer that has spread or come back.
What could go wrong
This is a small, early-phase study with only 21 participants, so results may not apply to everyone. The combination may not improve outcomes and could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

21 people

The number who actually took part.

Started

Aug 2020

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck squamous cell carcinoma

Contacts and locations

Locations

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.