Neoadjuvant PD-1 Blockade for Melanoma
What You Need to Know Before You Apply
What is the purpose of this trial?
The main purpose of this study is to determine the rate of positive sentinel lymph nodes (i.e. the closest draining lymph node(s) to the primary melanoma site) and to test whether treatment with pembrolizumab before surgery to remove melanoma reduces the rate of positive sentinel lymph nodes in patients with Stage IIB/C melanoma.Subjects with stage II melanoma will receive one dose of pembrolizumab 200 mg, then undergo standard definitive surgery with wide excision and sentinel lymph node (SLN) biopsy approximately 3 weeks after the initial dose of pembrolizumab. Post-operatively, subjects will receive up to 1 year of adjuvant pembrolizumab 200 mg every 3 weeks.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or certain other treatments, you may need to stop them before starting the trial. It's best to discuss your specific medications with the trial team.
Is neoadjuvant PD-1 blockade for melanoma safe for humans?
PD-1 blocking drugs like Pembrolizumab (also known as KEYTRUDA or MK-3475) have been used in treating various cancers, including melanoma, and are generally considered safe for outpatient use. However, they can cause immune-related side effects, which occur when the immune system becomes overactive, but these are usually manageable with proper care.12345
How is the neoadjuvant PD-1 blockade treatment for melanoma different from other treatments?
Neoadjuvant PD-1 blockade for melanoma is unique because it is given before surgery to help shrink the tumor and improve immune response, potentially leading to better outcomes compared to treatments given after surgery. This approach uses drugs like nivolumab, which have shown to enhance survival and immune responses with lower toxicity compared to some combination therapies.678910
What data supports the effectiveness of the treatment Neoadjuvant PD-1 Blockade for Melanoma?
The research highlights the importance of sentinel lymph node biopsy (SLNB) in improving long-term survival for melanoma patients, which is part of the treatment plan. While specific data on Pembrolizumab (a drug that helps the immune system fight cancer) for melanoma isn't provided, SLNB's role in better outcomes suggests the treatment's potential effectiveness.1112131415
Who Is on the Research Team?
Giorgos Karakousis, MD
Principal Investigator
Abramson Cancer Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Participants receive one dose of pembrolizumab 200 mg
Surgery
Participants undergo wide excision and sentinel lymph node biopsy
Adjuvant Treatment
Participants receive up to 1 year of adjuvant pembrolizumab 200 mg every 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- Wide Excision and Sentinel Lymph Node (SLN) Biopsy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Abramson Cancer Center of the University of Pennsylvania
Lead Sponsor
Abramson Cancer Center at Penn Medicine
Lead Sponsor