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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 below

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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:

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My liver is not functioning well (Child-Pugh score >6).

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 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

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

~3150

0 / 14Eligibility criteria met