At a glance
ClinicalIndex Comparison RecordPhase 2Active· 21 enrolled
Drug / intervention
Metformin Extended Release Oral Tablet +1 moredrug
Likely dose
Metformin Extended Release Oral Tablet 1000mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Feasibility Study Combining Pembrolizumab and Metformin to Harness the Natural Killer Cytotoxic Response in Metastatic Head and Neck Cancer Patients
In Brief
A Phase 2 clinical trial evaluating Metformin Extended Release Oral Tablet and Pembrolizumab for Head and Neck Squamous Cell Carcinoma. Active but no longer recruiting, targeting 21 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Squamous Cell Carcinoma
CountriesUnited States
CollaboratorsAmerican Cancer Society, Inc.
Timeline
Phase 2Active
202120222023202420252026
First PostedJun 2020
Enrollment StartAug 2020
Primary CompletionFeb 2026
TodayJul 2026
Study CompletionSep 2026
First PostedJun 4, 2020
Enrollment StartAug 31, 2020
Primary CompletionFeb 2, 2026
Study CompletionSep 30, 2026
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 6.1 years ago
Interventions
Metformin Extended Release Oral Tabletdrug
Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily
Pembrolizumabdrug
Pembrolizumab q 3 weeks