← Back to Search

Neoadjuvant PD-1 Blockade for Melanoma

Phase 2
Recruiting
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 be ≥18 years of age on day of signing informed consent.
The subject must have clinical stage IIB or IIC resectable MEL. Subjects may not have a diagnosis of uveal or mucosal melanoma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am 18 years old or older.
Select...
My melanoma is at stage IIB or IIC and can be surgically removed. I do not have uveal or mucosal melanoma.
Select...
I am not pregnant and follow the required birth control guidelines.
Select...
I agree to follow the study's rules for using birth control.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My organ functions are within the required range for the study.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
SLN Positivity Rate
Safety and Tolerability as measured by observed adverse events.
Secondary outcome measures
Disease-Free Survival (DFS)
Overall Survival

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 2
~2010

Find a Location

Who is running the clinical trial?

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,032 Total Patients Enrolled
16 Trials studying Melanoma
861 Patients Enrolled for Melanoma
Abramson Cancer Center at Penn MedicineLead Sponsor
385 Previous Clinical Trials
144,838 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

Wide Excision and Sentinel Lymph Node (SLN) Biopsy Clinical Trial Eligibility Overview. Trial Name: NCT03757689 — Phase 2
Melanoma Research Study Groups: Neoadjuvant Pembrolizumab
Melanoma Clinical Trial 2023: Wide Excision and Sentinel Lymph Node (SLN) Biopsy Highlights & Side Effects. Trial Name: NCT03757689 — Phase 2
Wide Excision and Sentinel Lymph Node (SLN) Biopsy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03757689 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for participants in this clinical trial?

"The clinicaltrials.gov website shows that this trial is still looking for volunteers. The listing was created on 7/1/2019 and the most recent update was on 5/17/2022."

Answered by AI

What has been the most successful application of Pembrolizumab?

"Pembrolizumab is used to treat cancer, specifically malignant neoplasms. Additionally, it can be used to manage unresectable melanoma, microsatellite instability high, and chemotherapy-induced disease progression."

Answered by AI

What have been the most severe side effects associated with Pembrolizumab?

"While there is some data supporting pembrolizumab's safety, as this drug is still in Phase 2 of clinical trials, its efficacy has yet to be studied."

Answered by AI

How many individuals are testing this new medication?

"Affirmative, the clinical trial is currently ongoing and looking for 63 patients from 1 location. The listing was created on July 1st, 2019 and last updated on May 17th, 2022."

Answered by AI

Are there any other ongoing or completed studies that use Pembrolizumab?

"There are currently 1000 clinical trials underway related to Pembrolizumab. 122 of those studies are in Phase 3 and the majority are located in Houston, Texas. However, there are a total of 36030 locations running Pembrolizumab studies."

Answered by AI
~8 spots leftby Dec 2024