63 Participants Needed

Neoadjuvant PD-1 Blockade for Melanoma

Recruiting at 2 trial locations
GK
Overseen ByGiorgos Karakousis, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Abramson Cancer Center of the University of Pennsylvania
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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?

GK

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

My melanoma is at stage IIB or IIC and can be surgically removed. I do not have uveal or mucosal melanoma.
I am not pregnant and follow the required birth control guidelines.
I agree to follow the study's rules for using birth control.
See 3 more

Exclusion Criteria

I have not received a live vaccine in the last 30 days.
My liver is not functioning well (Child-Pugh score >6).
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
See 21 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive one dose of pembrolizumab 200 mg

3 weeks
1 visit (in-person)

Surgery

Participants undergo wide excision and sentinel lymph node biopsy

1 day
1 visit (in-person)

Adjuvant Treatment

Participants receive up to 1 year of adjuvant pembrolizumab 200 mg every 3 weeks

1 year
Approximately 17 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Pembrolizumab
  • Wide Excision and Sentinel Lymph Node (SLN) Biopsy
Trial Overview 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.
How Is the Trial Designed?
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials
360
Recruited
108,000+

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials
425
Recruited
464,000+

Published Research Related to This Trial

In a study of 88 advanced melanoma patients treated with pembrolizumab, 81.8% experienced any-grade toxicities, with skin and gastrointestinal issues being the most common side effects.
Despite the high incidence of side effects, pembrolizumab was found to be well tolerated in real-world settings, and severe toxicities were manageable with systemic steroids.
Real-world experience with pembrolizumab toxicities in advanced melanoma patients: a single-center experience in the UK.So, AC., Board, RE.[2022]
Blocking the PD-1 pathway with specific drugs has shown clinical effectiveness in treating advanced cancers like melanoma and lung cancer, by enhancing the body's anti-tumor immune response.
These PD-1/PD-L1 blocking drugs have a manageable safety profile, making them suitable for outpatient treatment and potential use in combination therapies, with ongoing research focused on identifying biomarkers for better patient selection.
Antagonists of PD-1 and PD-L1 in Cancer Treatment.Lipson, EJ., Forde, PM., Hammers, HJ., et al.[2022]
Immune checkpoint antibodies targeting the PD-1/PD-L1 pathway have shown significant antitumor activity and have been approved for use as single-agent therapies in metastatic malignant melanoma and nonsmall-cell lung cancer.
Understanding the toxicities associated with PD-1/PD-L1 blockade and having effective management strategies is crucial for maximizing both the safety and efficacy of these treatments.
Toxicities of the anti-PD-1 and anti-PD-L1 immune checkpoint antibodies.Naidoo, J., Page, DB., Li, BT., et al.[2023]

Citations

Sentinel lymph node status affects long-term survival in patients with intermediate-thickness melanoma. [2023]
Long-term follow-up reveals that ulceration and sentinel lymph node status are the strongest predictors for survival in patients with primary cutaneous melanoma. [2022]
Primary excision margins, sentinel lymph node biopsy, and completion lymph node dissection in cutaneous melanoma: a clinical practice guideline. [2023]
Sentinel-node biopsy or nodal observation in melanoma. [2022]
Effect of the time interval between melanoma diagnosis and sentinel node biopsy on the size of metastatic tumour deposits in node-positive patients. [2022]
Immune-Related Adverse Events in PD-1 Treated Melanoma and Impact Upon Anti-Tumor Efficacy: A Real World Analysis. [2022]
Real-world experience with pembrolizumab toxicities in advanced melanoma patients: a single-center experience in the UK. [2022]
Antitumor efficacy of combined CTLA4/PD-1 blockade without intestinal inflammation is achieved by elimination of FcγR interactions. [2021]
Antagonists of PD-1 and PD-L1 in Cancer Treatment. [2022]
Toxicities of the anti-PD-1 and anti-PD-L1 immune checkpoint antibodies. [2023]
Serum lactate dehydrogenase as an early marker for outcome in patients treated with anti-PD-1 therapy in metastatic melanoma. [2022]
Soluble CD73 as biomarker in patients with metastatic melanoma patients treated with nivolumab. [2018]
13.United Statespubmed.ncbi.nlm.nih.gov
Extended dose ipilimumab with a peptide vaccine: immune correlates associated with clinical benefit in patients with resected high-risk stage IIIc/IV melanoma. [2021]
14.United Statespubmed.ncbi.nlm.nih.gov
Neoadjuvant immune checkpoint blockade in high-risk resectable melanoma. [2021]
15.United Statespubmed.ncbi.nlm.nih.gov
Association of Pembrolizumab With Tumor Response and Survival Among Patients With Advanced Melanoma. [2022]
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