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Checkpoint Inhibitor
Pembrolizumab for Desmoplastic Melanoma
Denver, CO
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.
See full description
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.Check my eligibility
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.See study design
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 belowSelect...
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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Select...
I have a specific type of skin cancer called desmoplastic melanoma that cannot be surgically removed.
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Select...
I have never needed steroids for non-infectious lung inflammation.
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Select...
I can handle my personal care but cannot work.
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Select...
I am 18 years old or older.
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Select...
I have not had any systemic treatment for my melanoma.
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Select...
I have a type of skin cancer called desmoplastic melanoma that can be surgically removed.
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Select...
I am not planning to receive any other cancer treatments while on this trial.
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Select...
I do not have an infection that needs treatment with drugs.
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Select...
I am not planning to receive any other cancer treatments while on this trial.
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Select...
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.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 moreOther 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 moreSide effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Vomiting
33%
Dysgeusia
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%
Alanine aminotransferase increased
20%
Hypoacusis
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Pharyngeal inflammation
13%
Acute kidney injury
13%
Pruritus
12%
Gamma-glutamyltransferase increased
12%
Dysphonia
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hyperglycaemia
8%
Dizziness
8%
Hyperuricaemia
8%
Hypophosphataemia
8%
Hiccups
7%
Ear pain
7%
Oral pain
7%
Erythema
7%
Localised oedema
7%
Urinary tract infection
7%
Hyperkalaemia
6%
Abdominal pain upper
6%
Saliva altered
6%
Dyspepsia
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
5%
Oedema peripheral
5%
Back pain
5%
Dyspnoea
5%
Hypertension
4%
Dry skin
4%
Nasopharyngitis
4%
Alopecia
3%
Trismus
3%
Laryngeal oedema
3%
Pneumonia aspiration
3%
Sepsis
3%
Pneumonitis
2%
Malnutrition
2%
Cellulitis
2%
Pharyngeal haemorrhage
1%
Colitis
1%
Hepatitis
1%
Hypersensitivity
1%
Abscess neck
1%
Immune-mediated hepatitis
1%
Stoma site infection
1%
Systemic infection
1%
Wound infection
1%
Hypercalcaemia
1%
Hypophagia
1%
Syncope
1%
Cerebrovascular accident
1%
Acute respiratory failure
1%
Aspiration
1%
Pulmonary embolism
1%
Respiratory failure
1%
Mouth haemorrhage
1%
Oesophagitis
1%
General physical health deterioration
1%
Bronchitis
1%
Clostridium difficile colitis
1%
Device related infection
1%
Septic shock
1%
Vascular device infection
1%
Tumour haemorrhage
1%
Death
1%
Acute myocardial infarction
1%
Cardiac arrest
100%
80%
60%
40%
20%
0%
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
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
~2630
Positron Emission Tomography
2011
Completed Phase 2
~2230
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9680
Magnetic Resonance Elastography
2019
N/A
~10
Biopsy
2014
Completed Phase 4
~1210
Biospecimen Collection
2004
Completed Phase 3
~1810
Computed Tomography
2017
Completed Phase 2
~2440
Find a Location
Closest Location:Good Samaritan Hospital - Cincinnati· Cincinnati, OH· 48 miles
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
14,068 Previous Clinical Trials
41,160,071 Total Patients Enrolled
Kari L KendraPrincipal InvestigatorSWOG Cancer Research Network
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My medical center will send my samples for a special review.I haven't needed treatment for an autoimmune disease in the last 2 years.I have treated brain metastases with no symptoms or need for recent steroids or seizure medications.I have not had any systemic treatment for my melanoma.I had surgery before, and any side effects are now mild or gone.Before joining the study, you need to have certain blood test results within the last 28 days.I had surgery before, and any side effects are now mild or gone.I have had CT scans of my chest, abdomen, and pelvis with contrast.My surgeon believes my cancer can be fully removed with surgery.I haven't needed treatment for an autoimmune disease in the last 2 years.I have not received any live vaccines in the last 42 days.I haven't had radiation, certain drugs, or steroids in the last 14 days.I have not had any other cancer types, with certain exceptions.I am a woman who can have children, tested negative for pregnancy, and agree to use birth control.I have treated brain metastases with no symptoms or need for recent steroids or seizure medications.I have a specific type of skin cancer called desmoplastic melanoma that cannot be surgically removed.I have never needed steroids for non-infectious lung inflammation.I am 18 years old or older.I still have cancer signs after my first biopsy.I am a woman who can have children, tested negative for pregnancy, and agree to use birth control.I have never needed steroids for non-infectious lung inflammation.I can handle my personal care but cannot work.I am 18 years old or older.If you have HIV, you can join the study if you meet certain conditions.I have not received any live vaccines in the last 42 days.I have not had any systemic treatment for my melanoma.In Cohort B, patients must have a way to measure their disease according to specific guidelines.I have a type of skin cancer called desmoplastic melanoma that can be surgically removed.I am not planning to receive any other cancer treatments while on this trial.I haven't had radiation, certain drugs, or steroids in the last 14 days.I do not have an infection that needs treatment with drugs.I am not planning to receive any other cancer treatments while on this trial.I do not have an infection that needs treatment with medication.I have not had any other cancer types, with certain exceptions.My medical center will send my samples for a special review.Before joining the study, your recent laboratory test results must meet certain specified values.I can perform all self-care but cannot work.If you have HIV and meet certain criteria, you can participate in Cohort A.I have had CT scans of my chest, abdomen, and pelvis with contrast.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort B (pembrolizumab)
- Group 2: Cohort A (pembrolizumab, surgery)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.