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Checkpoint Inhibitor

Pembrolizumab for High-risk Stage II Melanoma

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

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

Must have

Has not been previously treated for melanoma beyond complete surgical resection

Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale or Lansky Play-Performance Scale (LPS) score ≥50 for participants ≤16 years old, or a Karnofsky Performance Scale (KPS) score ≥50 for participants >16 and <18 years old

Must not have

Has received a live vaccine within 30 days prior to the first dose of study treatment

Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~15 years

Awards & highlights

Pivotal Trial

Summary

This trial will evaluate the safety and efficacy of pembrolizumab compared to placebo in participants with surgically resected high-risk Stage II melanoma. The primary hypothesis is that pembrolizumab increases recurrence-free survival.

Who is the study for?

This trial is for individuals with a new diagnosis of high-risk Stage II melanoma that's been surgically removed. They haven't had other melanoma treatments, are within 12 weeks post-surgery, and show no metastasis. Participants must be in good physical condition (ECOG score 0 or 1) and not pregnant or breastfeeding, agreeing to use contraception.

What is being tested?

The study tests pembrolizumab against a placebo in people who've had high-risk Stage II melanoma surgery. It's double-blind at first: patients get either the drug or placebo every three weeks for about a year. If the cancer returns, they can get more pembrolizumab openly for up to two years.

What are the potential side effects?

Pembrolizumab may cause immune system-related side effects like inflammation in various organs, skin reactions, fatigue, flu-like symptoms, hormonal gland problems (like thyroid), and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

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

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I have only had surgery for my melanoma, no other treatments.

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I am mostly active and can carry out daily activities without significant help.

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My melanoma was surgically removed and confirmed to be Stage IIB or IIC.

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 an immune system disorder or have been on steroids or other immune-weakening medicines recently.

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I have been treated with specific immune therapy for cancer.

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I have received treatment for melanoma before, including experimental drugs.

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I have an autoimmune disease treated with medication in the last 2 years.

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I have a history of hepatitis B or active hepatitis C.

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I have received a transplant from another person.

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I have had pneumonitis treated with steroids or have it now.

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I have had active tuberculosis in the past.

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I am currently being treated for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~15 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

Recurrence-free Survival (RFS)

Secondary study objectives

Distant Metastasis-free Survival (DMFS)

Number of Participants Who Discontinued Study Treatment Due to an AE

Number of Participants Who Experienced at Least One Adverse Event (AE)

+1 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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PembrolizumabExperimental Treatment1 Intervention

Participants receive 200 mg pembrolizumab (2 mg/kg for a maximum of 200 mg in pediatric participants) by intravenous (IV) infusion once every 3 weeks (Q3W; 21-day cycles) for up to 17 cycles (up to \~1 year) in Part 1. Participants who complete the initial treatment of 17 cycles of pembrolizumab and experience disease recurrence may be eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2.

Group II: PlaceboPlacebo Group2 Interventions

Participants receive saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to \~1 year) in Part 1. Participants who complete the initial treatment of 17 cycles of placebo and experience disease recurrence may be eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~2810

0 / 13Eligibility criteria met