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Pembrolizumab for Merkel Cell Carcinoma (MCC Trial)

Phase 2

Recruiting

Led By John Miura, MD

Research Sponsored by Abramson Cancer Center at Penn Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female subjects must not be pregnant, not breastfeeding, and meet contraceptive requirements

Must be expected to have an adequate amount of tumor burden for pre-operative research core biopsy specimens

Must not have

Received a live vaccine within 30 days before the first dose of study intervention

History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the effectiveness of the immunotherapy drug pembrolizumab in treating Merkel cell carcinoma before and after surgery. It also aims to assess any associated side effects.

Who is the study for?

This trial is for individuals with resectable stage I-III Merkel Cell Carcinoma (MCC). Participants must have a measurable tumor, provide tissue samples, agree to use contraception if applicable, and not be pregnant or breastfeeding. They should have good performance status and organ function. Those with certain hepatitis conditions may qualify but can't join if they've had recent cancer treatments, live vaccines, active infections including HIV/HBV/HCV, severe allergies to pembrolizumab components or certain medical conditions.

What is being tested?

The study tests the effects of pembrolizumab on MCC when given before surgery. It aims to see if this treatment reduces the risk of cancer coming back post-surgery. The drug's side effects will also be monitored in patients who receive it as part of their pre-and post-operative care.

What are the potential side effects?

Pembrolizumab may cause immune-related side effects such as inflammation in various organs like lungs (pneumonitis), liver problems, skin reactions, hormone gland issues (like thyroid disorders), infusion-related reactions and could potentially worsen autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant, not breastfeeding, and follow the contraceptive guidelines.

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My tumor is large enough for a biopsy needed before surgery.

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I am a man and I agree to use birth control and not donate sperm.

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I am willing to have two tumor biopsies for testing.

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I am positive for Hepatitis B under specific conditions.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My Merkel cell carcinoma can be surgically removed and is stage I-III.

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I had Hepatitis C but meet specific health criteria now.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not received a live vaccine in the last 30 days.

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I have or had lung inflammation that needed steroids.

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I have received an organ or tissue transplant from another person.

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I have been diagnosed with HIV.

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I have been treated for an autoimmune disease in the last 2 years.

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I am currently being treated for an infection.

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I have an immune system disorder or I'm on long-term steroids.

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I have had cancer treatment within the last 4 weeks.

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I have both Hepatitis B and C.

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My condition cannot be treated with surgery.

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I have received treatment with specific drugs before.

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My cancer has spread to my brain or its coverings.

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I have another cancer that is getting worse or was treated in the last 3 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 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

Heart rate

Secondary study objectives

Frequency and incidence of adverse events

Tumor infiltrating response (TIL)

Two Year Recurrence-Free Survival

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

Systemic infection

Clostridium difficile colitis

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

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PembrolizumabExperimental Treatment1 Intervention

Study participants will undergo a tumor tissue collection biopsy prior to treatment, followed by one dose of pembrolizumab 400mg, then undergo a curative intent resection of all remaining disease 3 weeks after the initial dose of pembrolizumab. Post-operatively, subjects will receive up to 1 year of pembrolizumab 400mg every 6 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

0 / 21Eligibility criteria met