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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
Study 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.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.
Select...
I am 18 years old or older.
Select...
I still have cancer signs after my first biopsy.
Select...
I haven't needed treatment for an autoimmune disease in the last 2 years.
Select...
I have not had any systemic treatment for my melanoma.
Select...
I have a specific type of skin cancer called desmoplastic melanoma that cannot be surgically removed.
Select...
I have never needed steroids for non-infectious lung inflammation.
Select...
I can handle my personal care but cannot work.
Select...
I am 18 years old or older.
Select...
I have not had any systemic treatment for my melanoma.
Select...
I have a type of skin cancer called desmoplastic melanoma that can be surgically removed.
Select...
I am not planning to receive any other cancer treatments while on this trial.
Select...
I do not have an infection that needs treatment with drugs.
Select...
I am not planning to receive any other cancer treatments while on this trial.
Select...
I do not have an infection that needs treatment with medication.
Select...
I have not had any other cancer types, with certain exceptions.
Select...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete response (CR) rate (Cohort B)
Pathologic complete response (pCR) rate (Cohort A)
Secondary outcome measures
9 week response rate (Cohort A)
Incidence of toxicity (Cohort A and B)
Overall survival rate (Cohort A and B)
+1 moreOther outcome measures
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 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
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
Positron Emission Tomography
2008
Completed Phase 2
~2240
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Pembrolizumab
2017
Completed Phase 2
~2010
Biopsy
2014
Completed Phase 4
~850
Biospecimen Collection
2004
Completed Phase 2
~1730
Computed Tomography
2017
Completed Phase 2
~2720
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,097 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Pembrolizumab been evaluated in previous trials?
"To date, there are 961 clinical investigations into pembrolizumab with 122 of them currently in phase 3. These trails originate from the city of Houston but have spread to 35727 locations around the world."
Answered by AI
To what extent is participation in this clinical experiment widespread?
"This study has closed its recruitment process, as the last edit of it was on November 16th 2022. For those seeking other clinical studies for desmoplastic melanoma and Pembrolizumab there are currently 754 and 961 respectively that are open to participants."
Answered by AI
How many medical sites are conducting this clinical research?
"This research project is actively recruiting participants at Fairview Southdale Hospital in Edina, Minnesota, Minnesota Oncology Hematology PA-Woodbury in Woodbury, Missouri and Saint Louis Cancer and Breast Institute-South City in Saint Louis, Utah alongside 100 additional sites."
Answered by AI
To what extent could Pembrolizumab be detrimental to patient health?
"Given the Phase 2 nature of this trial, our team at Power rated pembrolizumab with a score of 2 in regards to safety as there is some evidence available but not much concerning effectiveness."
Answered by AI
What is the desired outcome from this experiment?
"This long-term clinical trial, which will span up to five years in duration, seeks to evaluate the complete response rate among Cohort B subjects. Secondary outcomes include incidence of toxicity (Cohort A) as defined by NCI Common Terminology for Adverse Events version 4.0., progression free survival (Cohorts A and B) estimated with 95% confidence intervals, and overall response rate (Cohort A), again measured through 95% CI estimates."
Answered by AI
Is this medical experiment currently accepting participants?
"Per the information on clinicaltrials.gov, this research effort is no longer actively accepting participants. It was initially posted to the website in October of 2016 and last updated in November of 2022; however, at present there are 1715 other medical studies seeking patients for enrollment."
Answered by AI
What therapeutic conditions is Pembrolizumab employed to address?
"Pembrolizumab is commonly used to combat malignant neoplasms, as well as any irresectable melanoma, microsatellite instability high cases that have progressed after chemotherapy."
Answered by AI
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