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

Sponsor
Universitair Ziekenhuis Brussel
Study ID
NCT07448831
Phase
PHASE2
Status
Recruiting
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Conditions

  • Melanoma (Skin Cancer)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    One administration of intravenous pembrolizumab 400 mg.

Study Details

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.

Key Dates

Start date
Apr 17, 2025
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2029

Study Design

Enrollment
49 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: High-risk primary cutaneous melanoma
    pT1b-3a Merlin high-risk and pT3b-4b

Primary Outcome Measure

Antitumor activity of pembrolizumab [ Time Frame: A period of 7 weeks ]

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