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Checkpoint Inhibitor

Pre- and Post-Surgery Pembrolizumab for Melanoma

Phase 2

Waitlist Available

Led By Sapna P Patel

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients must have clinically detectable stage III (clinically detectable N1b, N1c, N2b, N2c, N3b and N3c) or stage IV resectable melanoma. Patients with melanoma of mucosal or acral origin are eligible. Patients with a history of brain metastases are not eligible.

Patients must not have an active infection requiring systemic therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration of treatment and follow-up until relapse, death, or 3.5 years post randomization.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether giving the immunotherapy drug pembrolizumab before and after surgery is better than giving it just after surgery for treating patients with high-risk melanoma.

Who is the study for?

This trial is for adults with high-risk melanoma (stage III-IV) that can be removed by surgery. They must not have had previous neoadjuvant immunotherapy or certain other treatments, no active infections, and no history of severe autoimmune disease or pneumonitis. Participants need functioning major organs, no brain metastases, and women of childbearing age must test negative for pregnancy.

What is being tested?

The study tests the effectiveness of Pembrolizumab, an immune system-boosting drug given before and after surgery versus only after surgery in treating melanoma. It's a phase II trial to see if this approach better prevents cancer from returning.

What are the potential side effects?

Pembrolizumab may cause side effects like fatigue, skin reactions, diarrhea, hormonal gland problems (like thyroid), liver inflammation, lung issues (pneumonitis), infusion reactions and could potentially worsen any pre-existing autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

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

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My melanoma is at stage III or IV and can be surgically removed, but I don't have brain metastases.

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I do not have an infection that needs treatment with medication.

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I've had a full check-up and scans showing no signs of cancer recently.

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I agree to provide tissue samples for testing after receiving pre-surgery treatment.

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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 melanoma was confirmed at its first appearance or when it spread.

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My melanoma is confirmed to be at least stage IIIB through biopsy.

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I will register for the next step of the trial at least 17 days before my surgery.

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I had surgery to completely remove my melanoma before joining Step 3.

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I've had surgery to remove my cancer and recent scans show no signs of cancer.

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I have not had an R2 resection.

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I do not have any visible cancer left after surgery.

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I am willing to provide tissue samples from my surgery for research.

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I have never needed steroids for non-infectious lung inflammation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ duration of treatment and follow-up until relapse, death, or 3.5 years post randomization.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~duration of treatment and follow-up until relapse, death, or 3.5 years post randomization.

This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of treatment and follow-up until relapse, death, or 3.5 years post randomization. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Two-Year Event-Free Survival Rate

Secondary study objectives

Number of Participants Receiving Surgery

Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug

Response Rate

+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

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (adjuvant pembrolizumab)Experimental Treatment5 Interventions

Within 17 days (preferably within 14 days) days after IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study.

Group II: Arm II (adjuvant and neoadjuvant pembrolizumab)Active Control5 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks for 3 cycles, then undergo surgery within 3 weeks. Within 84 days, patients receive pembrolizumab IV over 30 minutes every 3 weeks for 15 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9930