Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Trisha Wise-Draper
With
American Cancer Society, Inc.
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients
