Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Trisha Wise-Draper
Study ID
NCT04414540
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Metformin Extended Release Oral Tablet — DRUG
    Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily
  • Pembrolizumab — DRUG
    Pembrolizumab q 3 weeks

Study Details

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.

Key Dates

Start date
Aug 31, 2020
Status verified
May 2026
Primary completion
Feb 2, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
21 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Metformin before Pembrolizumab
    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.
  • Experimental: Arm 2: Metformin after Pembrolizumab
    D-21 Begin Pembrolizumab 200mg. D-7 begin Metformin ER 1000mg daily. D1 begin Metformin ER 2000mg daily. Continue Pembrolizumab 200mg every 3 weeks.

Primary Outcome Measure

Overall Response Rate by RECIST 1.1 and iRECIST [ Time Frame: Up to 2 years after completion of study treatment ]

Locations (1)

FacilityCityStateZIP
University of Cincinnati Medical CenterCincinnatiOhio45219

Related coverage on Hipa.ai

Find similar trials in Cincinnati, OH

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
University of Cincinnati Medical Center· Cincinnati, OH

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