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Neoadjuvant PD-1 Blockade for Melanoma
Phase 2
Waitlist Available
Led By Giorgos Karakousis, MD
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The subject must have clinical stage IIB or IIC resectable MEL. Subjects may not have a diagnosis of uveal or mucosal melanoma.
The subject must have a performance status of 0 or 1 on the ECOG Performance Scale.
Must not have
Has hepatic decompensation (Child-Pugh score >6 [class B and C]).
Has uncontrolled thyroid dysfunction.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether giving the drug pembrolizumab before surgery can reduce the rate of positive sentinel lymph nodes in patients with Stage IIB/C melanoma.
Who is the study for?
This trial is for adults over 18 with Stage IIB/C melanoma that can be surgically removed. They must have good performance status, normal organ function, and agree to contraception rules. Excluded are those with non-resectable melanoma, recent treatments or surgeries, severe allergies to pembrolizumab, active infections including HIV/Hepatitis B/C/TB, certain heart diseases, live vaccines taken recently, immunodeficiencies or suppressive therapies within a week before the trial.
What is being tested?
The study tests if pembrolizumab given before surgery reduces positive sentinel lymph nodes in patients with Stage IIB/C melanoma. Participants receive one dose of pembrolizumab followed by surgery after about three weeks and then up to one year of adjuvant therapy post-operation.
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs (like lungs), skin reactions, hormone gland problems (thyroid dysfunction), infusion reactions during administration and could potentially worsen autoimmune diseases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My melanoma is at stage IIB or IIC and can be surgically removed. I do not have uveal or mucosal melanoma.
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I am fully active or restricted in physically strenuous activity but can do light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My liver is not functioning well (Child-Pugh score >6).
Select...
My thyroid condition is not under control.
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I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.
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I do not have severe heart conditions like serious arrhythmias, advanced heart failure, or symptomatic heart disease.
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I have another cancer that is getting worse or needs treatment.
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I am a woman who can have children and I tested positive for pregnancy recently.
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I am currently being treated for an infection.
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I have an active tuberculosis infection.
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I have a history of Hepatitis B or active Hepatitis C.
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I have been treated with drugs that target the immune system.
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I have or had lung inflammation that needed steroids.
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My diabetes is not under control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
SLN Positivity Rate
Safety and Tolerability as measured by observed adverse events.
Secondary study objectives
Disease-Free Survival (DFS)
Overall Survival
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Neoadjuvant PembrolizumabExperimental Treatment2 Interventions
Subjects will receive one dose of pembrolizumab 200 mg. Approximately 3 weeks after the initial dose of pembrolizumab, subjects will undergo wide excision and sentinel lymph node (SLN) biopsy. Post-operatively, subjects will receive up to 1 year of adjuvant pembrolizumab 200 mg every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2810
Find a Location
Who is running the clinical trial?
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
108,450 Total Patients Enrolled
16 Trials studying Melanoma
861 Patients Enrolled for Melanoma
Abramson Cancer Center at Penn MedicineLead Sponsor
413 Previous Clinical Trials
165,151 Total Patients Enrolled
17 Trials studying Melanoma
886 Patients Enrolled for Melanoma
Giorgos Karakousis, MDPrincipal InvestigatorAbramson Cancer Center
2 Previous Clinical Trials
1 Total Patients Enrolled
2 Trials studying Melanoma
1 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine in the last 30 days.My liver is not functioning well (Child-Pugh score >6).My thyroid condition is not under control.I am 18 years old or older.I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.My melanoma is at stage IIB or IIC and can be surgically removed. I do not have uveal or mucosal melanoma.I do not have severe heart conditions like serious arrhythmias, advanced heart failure, or symptomatic heart disease.I am not pregnant and follow the required birth control guidelines.I have another cancer that is getting worse or needs treatment.I am a woman who can have children and I tested positive for pregnancy recently.I am currently being treated for an infection.I haven't had cancer treatment or experimental drugs in the last 4 weeks.You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.I have an active tuberculosis infection.My melanoma cannot be fully removed by surgery according to my surgeon.I agree to follow the study's rules for using birth control.I have an autoimmune disease treated within the last 3 months.You have been diagnosed with HIV.I have a history of Hepatitis B or active Hepatitis C.I have been treated with drugs that target the immune system.I have recovered from any major surgery before starting the study treatment.I have not received blood products or colony stimulating factors in the last 4 weeks.I have or had lung inflammation that needed steroids.I am fully active or restricted in physically strenuous activity but can do light work.My organ functions are within the required range for the study.My diabetes is not under control.
Research Study Groups:
This trial has the following groups:- Group 1: Neoadjuvant Pembrolizumab
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.
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