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Pembrolizumab for Merkel Cell Carcinoma (MCC Trial)
Phase 2
Recruiting
Led By John Miura, MD
Research Sponsored by Abramson Cancer Center at Penn Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female subjects must not be pregnant, not breastfeeding, and meet contraceptive requirements
Must be expected to have an adequate amount of tumor burden for pre-operative research core biopsy specimens
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2 years
Awards & highlights
MCC Trial Summary
This trial is testing the effectiveness of the immunotherapy drug pembrolizumab in treating Merkel cell carcinoma before and after surgery. It also aims to assess any associated side effects.
Who is the study for?
This trial is for individuals with resectable stage I-III Merkel Cell Carcinoma (MCC). Participants must have a measurable tumor, provide tissue samples, agree to use contraception if applicable, and not be pregnant or breastfeeding. They should have good performance status and organ function. Those with certain hepatitis conditions may qualify but can't join if they've had recent cancer treatments, live vaccines, active infections including HIV/HBV/HCV, severe allergies to pembrolizumab components or certain medical conditions.Check my eligibility
What is being tested?
The study tests the effects of pembrolizumab on MCC when given before surgery. It aims to see if this treatment reduces the risk of cancer coming back post-surgery. The drug's side effects will also be monitored in patients who receive it as part of their pre-and post-operative care.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs like lungs (pneumonitis), liver problems, skin reactions, hormone gland issues (like thyroid disorders), infusion-related reactions and could potentially worsen autoimmune diseases.
MCC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant, not breastfeeding, and follow the contraceptive guidelines.
Select...
My tumor is large enough for a biopsy needed before surgery.
Select...
I am a man and I agree to use birth control and not donate sperm.
Select...
I am willing to have two tumor biopsies for testing.
Select...
I am positive for Hepatitis B under specific conditions.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My Merkel cell carcinoma can be surgically removed and is stage I-III.
Select...
I had Hepatitis C but meet specific health criteria now.
MCC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Heart rate
Secondary outcome measures
Frequency and incidence of adverse events
Tumor infiltrating response (TIL)
Two Year Recurrence-Free Survival
Side 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
MCC Trial Design
1Treatment groups
Experimental Treatment
Group I: PembrolizumabExperimental Treatment1 Intervention
Study participants will undergo a tumor tissue collection biopsy prior to treatment, followed by one dose of pembrolizumab 400mg, then undergo a curative intent resection of all remaining disease 3 weeks after the initial dose of pembrolizumab. Post-operatively, subjects will receive up to 1 year of pembrolizumab 400mg every 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
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Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,890 Previous Clinical Trials
5,060,322 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,649 Total Patients Enrolled
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,049 Total Patients Enrolled
Media Library
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.
To what extent can Pembrolizumab be detrimental to individuals?
"Our team at Power granted Pembrolizumab a rating of 2, as this is currently a Phase 2 clinical trial. This implies that there exists some evidence to suggest the drug's safety but none to prove its efficacy."
Answered by AI
Are researchers currently enrolling participants for the research project?
"Verifying the information from clinicaltrials.gov, this medical trial is presently not actively seeking participants. Initially posted on January 1st 2023 and last updated November 8th 2022, it has since concluded its recruitment process; however, there are 2,474 other studies that remain open to potential patients."
Answered by AI
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