NCT04414540Active, not recruitingPhase 2
Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients
A Phase 2 Feasibility Study Combining Pembrolizumab and Metformin to Harness the Natural Killer Cytotoxic Response in Metastatic Head and Neck Cancer Patients
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 11 May 2020
- Start date
- 31 Aug 2020
- Primary completion date
- 2 Feb 2026
- Lead sponsor
- Trisha Wise-Draper
- Diseases
- Head and neck cancer
- NCT number
- NCT04414540
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 21
- From 31 Aug 2020 to the primary completion date, 2 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- Patients with nasopharyngeal HNSCC will be excluded
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Cincinnati Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.