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.
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
Drug | Synonyms | Arms |
---|
Metformin Extended Release Oral Tablet | Glucophage XR | Arm 1: Metformin before Pembrolizumab |
Pembrolizumab | Keytruda | Arm 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
Name | Type | Description | Interventions |
---|
Arm 1: Metformin before Pembrolizumab | Experimental | 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. | - Metformin Extended Release Oral Tablet
- Pembrolizumab
|
Arm 2: Metformin after Pembrolizumab | Experimental | D-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: | Recruiting |
Lead Sponsor: | Trisha Wise-Draper |
Last Updated
September 3, 2020