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Checkpoint Inhibitor

Pembrolizumab for Desmoplastic Melanoma

Phase 2

Waitlist Available

Led By Kari L Kendra

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

COHORT A: Patients must not have history of (non-infectious) pneumonitis that required steroids or current pneumonitis

COHORT B: Patients must be >= 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well pembrolizumab works in treating patients with DM.

Who is the study for?

Adults with desmoplastic melanoma, a type of skin cancer, that can either be surgically removed or not. Participants must not have had prior treatments for this cancer or certain other therapies and drugs recently. They should not have active infections, autoimmune diseases needing recent treatment, or untreated brain metastases. Women who can bear children must test negative for pregnancy and agree to use contraception.

What is being tested?

The trial is testing pembrolizumab's effectiveness on resectable (can be removed by surgery) and unresectable (cannot be removed by surgery) desmoplastic melanoma. Pembrolizumab is an immunotherapy drug designed to help the immune system fight cancer cells. The study includes imaging tests like CT scans and may involve biopsies and collecting tissue samples.

What are the potential side effects?

Pembrolizumab may cause side effects such as fatigue, itching, rash, diarrhea, joint pain, flu-like symptoms, shortness of breath or cough if it affects the lungs; hormonal gland problems; infusion reactions; liver inflammation; intestinal inflammation causing abdominal pain & bleeding.

Eligibility Criteria

Inclusion Criteria

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

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

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I am 18 years old or older.

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I still have cancer signs after my first biopsy.

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I haven't needed treatment for an autoimmune disease in the last 2 years.

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I have not had any systemic treatment for my melanoma.

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I have a specific type of skin cancer called desmoplastic melanoma that cannot be surgically removed.

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

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I can handle my personal care but cannot work.

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I am 18 years old or older.

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I have not had any systemic treatment for my melanoma.

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I have a type of skin cancer called desmoplastic melanoma that can be surgically removed.

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I am not planning to receive any other cancer treatments while on this trial.

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

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I am not planning to receive any other cancer treatments while on this trial.

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

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I have not had any other cancer types, with certain exceptions.

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I can perform all self-care but cannot work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Complete Response (CR) Rate (Cohort B)

Pathologic Complete Response (pCR) Rate (Cohort A)

Secondary study objectives

9 Week Response Rate (Cohort A)

Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

Overall Survival (Cohort A and B)

+1 more

Other study objectives

Adaptive Immune Resistant Mechanism (Cohort A and B)

Baseline Mutational Load (Cohort A and B)

Change in T-cell Infiltration (Cohort A and B)

+2 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

Group I: Cohort B (pembrolizumab)Experimental Treatment6 Interventions

Patients with unresectable disease receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 34 cycles in the absence of disease progression or toxicity. Patients undergo CT scan and may undergo PET and MRI throughout the study. Patients also undergo blood sample collection at screening and tumor biopsy throughout the study.

Group II: Cohort A (pembrolizumab, surgery)Experimental Treatment7 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles. Patients with potentially resectable disease undergo surgery. Patients with tumor progression and unresectable disease may receive one additional cycle of pembrolizumab. Patients undergo CT scan and may undergo PET and MRI throughout the study. Patients also undergo blood sample collection at screening and tumor biopsy throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~2810

Positron Emission Tomography

2011

Completed Phase 2

~2200