Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients

Phase 2Active Not RecruitingNCT04414540

Trisha Wise-Draper21 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Squamous Cell Carcinoma

Interventions

Metformin Extended Release Oral TabletDRUG

Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily

PembrolizumabDRUG

Pembrolizumab q 3 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 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

Locations (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Overall Response Rate by RECIST 1.1 and iRECIST

A complete response is defined as the disappearance of all target lesions, with any affected lymph nodes reduced to less than 10 mm. A partial response occurs when there is at least a 30% reduction in the total size of target lesions compared with baseline. Progressive disease is indicated by at least a 20% increase in lesion size (with a minimum absolute increase of 5 mm) or the appearance of new lesions. Stable disease describes cases where tumor size changes do not meet criteria for partial response or progressive disease.

Time frame: Up to 2 years after completion of study treatment

Secondary Outcomes

Number of Patients With Adverse Events Measured by CTCAE v5.0

To observe and record safety of combination in metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) patients receiving the combination of metformin and pembrolizumab. AEs will be graded and recorded according to NCI CTCAE Version 5.0.

Time frame: 2 years

Progression Free Survival (PFS)

To observe and record progression free survival in recurrent and/or metastatic HNSCC patients receiving the combination of metformin and pembrolizumab.

Time frame: 1 year

Overall Survival (OS)

Overall survival was analyzed using the Kaplan-Meier method. The reported 1-year overall survival percentages represent Kaplan-Meier-estimated probabilities of survival at 1 year and do not correspond to the observed proportion of participants alive or deceased due to censoring. Observed all-cause mortality is reported separately as the number of participants who died due to any cause in each arm.

Time frame: 1 year

Data from ClinicalTrials.gov

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