Trial Summary
What is the purpose of this trial?
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.
Research Team
Trisha Wise-Draper, MD,PhD
Principal Investigator
University of Cincinnati
Eligibility Criteria
This trial is for adults with recurrent or metastatic non-cutaneous head and neck cancers (HNSCC) who have tried up to three treatments without a cure. They should be fairly active and able to care for themselves (ECOG ≤2). People can't join if they've had certain cancer drugs recently, are already on metformin, or have nasopharyngeal HNSCC.Inclusion Criteria
I can take care of myself but might not be able to do heavy physical work.
My head or neck cancer has returned or spread, and surgery or radiation can't cure it.
I have had up to 3 treatments for my cancer since it spread or came back.
Exclusion Criteria
I have cancer in the upper part of my throat behind the nose.
I haven't had chemotherapy or radiotherapy in the last 2 weeks.
I still have side effects from previous cancer treatments.
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Treatment Details
Interventions
- Metformin Extended Release Oral Tablet (Other)
- Pembrolizumab (Monoclonal Antibodies)
Trial OverviewThe study tests combining Pembrolizumab, an immune therapy drug, with Metformin Extended Release tablets in patients with advanced head and neck cancer. The goal is to see how well tumors respond to this combination treatment.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Arm 2: Metformin after PembrolizumabExperimental Treatment2 Interventions
D-21 Begin Pembrolizumab 200mg. D-7 begin Metformin ER 1000mg daily. D1 begin Metformin ER 2000mg daily. Continue Pembrolizumab 200mg every 3 weeks.
Group II: Arm 1: Metformin before PembrolizumabExperimental Treatment2 Interventions
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.
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Who Is Running the Clinical Trial?
Trisha Wise-Draper
Lead Sponsor
Trials
6
Recruited
230+
American Cancer Society, Inc.
Collaborator
Trials
237
Recruited
110,000+
Dr. Larry Weiss
American Cancer Society, Inc.
Chief Medical Officer since 2016
MD from Duke University Medical Center
Dr. Wayne A. I. Frederick
American Cancer Society, Inc.
Chief Executive Officer
MD from Howard University, MBA from Howard University