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Pembrolizumab + Metformin for Head and Neck Cancer

Phase 2
Waitlist Available
Led By Trisha Wise-Draper, MD, PhD
Research Sponsored by Trisha Wise-Draper
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status ≤2
Histologically or cytologically confirmed recurrent or metastatic non-cutaneous HNSCC for which there are no surgical or radiation curative options
Must not have
Patients with nasopharyngeal HNSCC
Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 20 Other Conditions

Summary

This trial will test whether combining metformin with pembrolizumab can help treat recurrent or metastatic head and neck squamous cell cancer.

Who is the study for?
This trial is for adults with recurrent or metastatic non-cutaneous head and neck cancers (HNSCC) who have tried up to three treatments without a cure. They should be fairly active and able to care for themselves (ECOG ≤2). People can't join if they've had certain cancer drugs recently, are already on metformin, or have nasopharyngeal HNSCC.
What is being tested?
The study tests combining Pembrolizumab, an immune therapy drug, with Metformin Extended Release tablets in patients with advanced head and neck cancer. The goal is to see how well tumors respond to this combination treatment.
What are the potential side effects?
Pembrolizumab may cause immune-related side effects like inflammation in organs, skin reactions, fatigue, and flu-like symptoms. Metformin can lead to digestive issues such as stomach pain and diarrhea but is generally well-tolerated.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My head or neck cancer has returned or spread, and surgery or radiation can't cure it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have cancer in the upper part of my throat behind the nose.
Select...
I haven't had chemotherapy or radiotherapy in the last 2 weeks.
Select...
I am currently taking metformin or have taken it in the last 6 months.
Select...
I have been treated with PD-1 or PD-L1 inhibitors for my cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Response by RECIST 1.1 and iRECIST
Secondary study objectives
Number of patients with adverse events measured by CTCAE v5.0
Overall Survival (OS)
Progression Free Survival (PFS)
Other study objectives
Cytokine levels including IL-2, IL-4, IL-6, IL-8, IL-10, INFgamma, TNFalpha in Plasma via ELISA based technology.
Percent secretion of NKG2D soluble ligands via ELISA.
Percent tumor infiltrating NK cells determined by immunofluorescence
+3 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999
64%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2: Metformin after PembrolizumabExperimental Treatment2 Interventions
D-21 Begin Pembrolizumab 200mg. D-7 begin Metformin ER 1000mg daily. D1 begin Metformin ER 2000mg daily. Continue Pembrolizumab 200mg every 3 weeks.
Group II: Arm 1: Metformin before PembrolizumabExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Metformin
FDA approved

Find a Location

Who is running the clinical trial?

American Cancer Society, Inc.OTHER
231 Previous Clinical Trials
109,691 Total Patients Enrolled
Trisha Wise-DraperLead Sponsor
5 Previous Clinical Trials
212 Total Patients Enrolled
Trisha Wise-Draper, MD, PhD3.02 ReviewsPrincipal Investigator - University of Cincinnati
University of Cincinnati
4 Previous Clinical Trials
176 Total Patients Enrolled
1Patient Review
I would not recommend this doctor to anyone. She was cold and had a nasty attitude. I don't think she knows what she's doing.

Media Library

Metformin Extended Release Oral Tablet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04414540 — Phase 2
Head and Neck Squamous Cell Carcinoma Research Study Groups: Arm 1: Metformin before Pembrolizumab, Arm 2: Metformin after Pembrolizumab
Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Metformin Extended Release Oral Tablet Highlights & Side Effects. Trial Name: NCT04414540 — Phase 2
Metformin Extended Release Oral Tablet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04414540 — Phase 2
~2 spots leftby Jul 2025
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