Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients

Phase 2

Active, not recruiting

• Conditions: Head and Neck Squamous Cell Carcinoma
• Interventions: Drug: Metformin Extended Release Oral Tablet; Drug: Pembrolizumab

• Registration Number: NCT04414540
• Lead Sponsor: Trisha Wise-Draper

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 pembrolizumab or to begin Metformin after pembrolizumab treatment begins. The patients are randomized for the exploratory endpoints in order to better understand the difference of effects of metformin versus pembrolizumab on the immune system although efficacy is based on combination.

Study Timeline

• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-29
• Study First Posted: 2020-06-04
• Study Start: 2020-08-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-01
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Metformin before Pembrolizumab	Metformin Extended Release Oral Tablet	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.
Arm 2: Metformin after Pembrolizumab	Metformin Extended Release Oral Tablet	D-21 Begin Pembrolizumab 200mg. D-7 begin Metformin ER 1000mg daily. D1 begin Metformin ER 2000mg daily. Continue Pembrolizumab 200mg every 3 weeks.
Arm 1: Metformin before Pembrolizumab	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.
Arm 2: Metformin after Pembrolizumab	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 Measures

Name	Time	Method
Overall Response by RECIST 1.1 and iRECIST	2 years	To determine anti-tumor activity by measuring overall response rate by RECIST 1.1 and iRECIST in recurrent and/or metastatic HNSCC patients receiving the combination of metformin and pembrolizumab.

Secondary Outcome Measures

Name	Time	Method
Number of patients with adverse events measured by CTCAE v5.0	2 years	To observe and record safety of combination in metastatic HNSCC patients receiving the combination of metformin and pembrolizumab. AEs will be graded and recorded according to NCI CTCAE Version 5.0.
Progression Free Survival (PFS)	1 year	To observe and record progression free survival in recurrent and/or metastatic HNSCC patients receiving the combination of metformin and pembrolizumab.
Overall Survival (OS)	1 year	To observe and record overall survival in recurrent and/or metastatic HNSCC patients receiving the combination of metformin and pembrolizumab.

Trial Locations

Locations (1)

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States