Clinical trial · Interventional
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
NCT04414540CI-TRIAL-00110978active not recruitingPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin Extended Release Oral Tablet | Drug | Metformin | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: Metformin before Pembrolizumab
- description
- 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.
- interventionNames
- Drug: Metformin Extended Release Oral Tablet
- Drug: Pembrolizumab
- type
- EXPERIMENTAL
- label
- Arm 2: Metformin after Pembrolizumab
- description
- D-21 Begin Pembrolizumab 200mg. D-7 begin Metformin ER 1000mg daily. D1 begin Metformin ER 2000mg daily. Continue Pembrolizumab 200mg every 3 weeks.
- interventionNames
- Drug: Metformin Extended Release Oral Tablet
- Drug: Pembrolizumab
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.