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OncoMatch/Clinical Trials/NCT07448831

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

Is NCT07448831 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pembrolizumab for melanoma (skin cancer).

Phase 2RecruitingUniversitair Ziekenhuis BrusselNCT07448831Data as of May 2026

Treatment: PembrolizumabThis 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.

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Extracted eligibility criteria

Cancer type

Melanoma

Disease stage

Required: Stage PT1B, PT2A, PT2B, PT3A, PT3B, PT4A, PT4B (AJCC8)

High risk primary melanoma is defined in this study as the following AJCC8 T-stages: * pT1b-3a, with a poor prognostic score on the Merlin™ test ("Merlin™ high risk"); * pT3b-4b, irrespective of their Merlin™ test result

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: checkpoint inhibitor

Patients who have previously been exposed to checkpoint inhibitors

Cannot have received: systemic treatment for melanoma

No prior exposure to systemic treatment for melanoma (adjuvant or curative)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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