RecruitingPhase 2NCT07448831

A Phase II Clinical Trial on Neo-adjuvant Pembrolizumab in Patients With pT3b-T4a/b cN0M0 Melanoma.

A Phase 2 Clinical Trial on Neoadjuvant Pembrolizumab in Patients Diagnosed With High-risk Melanoma Without Clinical Evidence of Metastatic Dissemination.

Sponsor

Universitair Ziekenhuis Brussel

Enrollment

49 participants

Start Date

Apr 17, 2025

Study Type

INTERVENTIONAL

Conditions

Melanoma (Skin Cancer)

Summary

This study, called NeoSenti, is exploring whether giving one dose of the immunotherapy drug pembrolizumab before surgery can help the immune system fight melanoma more effectively. The study includes adults with high-risk melanoma who do not show any signs of the cancer having spread on scans. Participants receive a single infusion of pembrolizumab six weeks before their scheduled sentinel lymph node biopsy. The goal is to see if this early treatment can reduce or eliminate tiny cancer cells that might already be in the lymph nodes but are too small to detect. After surgery, patients whose melanoma stage normally requires further treatment will continue with standard immunotherapy for one year. Others will move directly into follow-up care. All participants are monitored closely for five years with regular scans, blood tests, and check-ups to watch for any signs of recurrence and to ensure their safety.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase II trial is testing pembrolizumab — an immunotherapy drug that helps the immune system attack cancer — given before surgery (called neoadjuvant therapy) in patients with high-risk melanoma that has not yet spread to distant parts of the body. The goal is to see if treating with immunotherapy before surgery shrinks the tumor and reduces the chance of it coming back. **You may be eligible if:** - You are 18 years of age or older - You have been diagnosed with high-risk primary cutaneous melanoma (confirmed by biopsy), defined as Stage pT3b–4b (deeply invasive tumors), or Stage pT1b–3a with a high-risk score on the Merlin test - You have not received any prior systemic treatment for melanoma - You are a candidate for sentinel lymph node biopsy - There is no evidence of distant spread (no metastases) - You are in good health (ECOG performance status 0, 1, or 2) - Women must not be pregnant and must use effective contraception if of childbearing age **You may NOT be eligible if:** - There is evidence of distant metastasis - You have already received any systemic treatment for melanoma - You have significant organ problems that would make immunotherapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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