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

NCT07448831 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2026-03-09

No results posted yet for this study

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.

Conditions

  • Melanoma (Skin Cancer)

Interventions

DRUG

Pembrolizumab

One administration of intravenous pembrolizumab 400 mg.

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    lead OTHER

Principal Investigators

  • Bart Neyns, Prof, MD, PhD · Universitair Ziekenhuis Brussel

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-17
Primary Completion
2026-06-30
Completion
2029-12-31

Countries

  • Belgium

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07448831 on ClinicalTrials.gov