Head and Neck Squamous Cell Carcinoma
Conditions
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.
Interventions
Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily
DRUGPembrolizumab
Pembrolizumab q 3 weeks
Sponsors
Trisha Wise-Draper
American Cancer Society, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be on one of two arms that will be studied in parallel.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate by RECIST 1.1 and iRECIST | Up to 2 years after completion of study treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Adverse Events Measured by CTCAE v5.0 | 2 years | 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. |
| 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 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTrisha Wise-Draper, MD, PhD
University of Cincinnati
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 64 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 7 Participants |
| Smoking History (>=10 pack years) | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 10 | 8 / 11 |
| other Total, other adverse events | 10 / 10 | 11 / 11 |
| serious Total, serious adverse events | 3 / 10 | 4 / 11 |
Outcome results
None listed