Clinical Trials /

Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients

NCT04414540

Description:

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.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients
  • Official Title: A Phase 2 Feasibility Study Combining Pembrolizumab and Metformin to Harness the Natural Killer Cytotoxic Response in Metastatic Head and Neck Cancer Patients

Clinical Trial IDs

  • ORG STUDY ID: UCCC-HN-19-01
  • NCT ID: NCT04414540

Conditions

  • Head and Neck Squamous Cell Carcinoma

Interventions

DrugSynonymsArms
Metformin Extended Release Oral TabletGlucophage XRArm 1: Metformin before Pembrolizumab
PembrolizumabKeytrudaArm 1: Metformin before Pembrolizumab

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Arm 1: Metformin before PembrolizumabExperimentalMetformin 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.
  • Metformin Extended Release Oral Tablet
  • Pembrolizumab
Arm 2: Metformin after PembrolizumabExperimentalD-21 Begin Pembrolizumab 200mg. D-7 begin Metformin ER 1000mg daily. D1 begin Metformin ER 2000mg daily. Continue Pembrolizumab 200mg every 3 weeks.
  • Metformin Extended Release Oral Tablet
  • Pembrolizumab

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Response by RECIST 1.1 and iRECIST
Time Frame:2 years
Safety Issue:
Description: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

Measure:Number of patients with adverse events measured by CTCAE v5.0
Time Frame:2 years
Safety Issue:
Description: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.
Measure:Progression Free Survival (PFS)
Time Frame:1 year
Safety Issue:
Description:To observe and record progression free survival in recurrent and/or metastatic HNSCC patients receiving the combination of metformin and pembrolizumab.
Measure:Overall Survival (OS)
Time Frame:1 year
Safety Issue:
Description:To observe and record overall survival in recurrent and/or metastatic HNSCC patients receiving the combination of metformin and pembrolizumab.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Trisha Wise-Draper

Last Updated

June 2, 2020