Active — Not RecruitingPhase 2

Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients

United States21 participantsStarted 2020-08-31

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall Response Rate by RECIST 1.1 and iRECIST

Timeframe: Up to 2 years after completion of study treatment

Trial details

NCT IDNCT04414540

SponsorTrisha Wise-Draper

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-02

Results submitted2026-03-09

View on ClinicalTrials.gov More Head and Neck Squamous Cell Carcinoma trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.