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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

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I can take care of myself but might not be able to do heavy physical work.

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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:

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I have cancer in the upper part of my throat behind the nose.

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I haven't had chemotherapy or radiotherapy in the last 2 weeks.

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I am currently taking metformin or have taken it in the last 6 months.

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I have been treated with PD-1 or PD-L1 inhibitors for my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Clostridium difficile colitis

Systemic infection

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

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

0 / 6Eligibility criteria met