Status:
ACTIVE_NOT_RECRUITING
Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients
Lead Sponsor:
Trisha Wise-Draper
Collaborating Sponsors:
American Cancer Society, Inc.
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
Recurrent and/or metastatic HNSCC patients will be treated with combination of metformin and pembrolizumab. Patients will be randomized into arms 1 and 2, to either receive Metformin prior to pembroli...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04414540
Start Date
August 31 2020
End Date
December 1 2025
Last Update
December 19 2025
Active Locations (1)
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1
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219