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.
pT1b-3a, with a poor prognostic score on the Merlin™ test ("Merlin™ high risk");
pT3b-4b, irrespective of their Merlin™ test result
Female patients must be surgically sterile or be postmenopausal (A postmenopausal state is defined as no menses for 12 months without an alternative medical cause).
If a female patient is a woman of childbearing potential (WOCBP) they must agree to use highly effective contraception measures during the period of therapy, which should be continued for at least 4 months following the last dose of pembrolizumab as indicated in the SmPC. A list of highly effective contraceptive measures is included in appendix 1 All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment and pregnancy testing should be conducted within 24h prior to the first dose of immune checkpoint inhibitors and thereafter monthly until 4 months following the last dose study treatment.
None
Single group
Pembrolizumab
DrugOne administration of intravenous pembrolizumab 400 mg.
Antitumor activity of pembrolizumab
To estimate the antitumor activity of pembrolizumab in high-risk primary cutaneous melanoma population (pT1b to pT4b) without clinical evidence of metastasis (cN0M0) in the neoadjuvant setting.
Relapse-free survival
To estimate relapse-free survival (RFS), defined as the time from study recruitment to the date of first recurrence (or death from any cause), over a period of five years.
Adverse events
To document the incidence and severity of adverse events in study patients as assessed by anamnesis, clinical examination, analysis of blood and any additional medical examination that is indicated.
Health-Related Quality of Life (HRQoL)
Measurement of health-related quality of life (HRQoL) through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30). The score on the EORTC-QLQ-C30 scale (range: 0-100). Higher scores indicate better health-related quality of life.
Presence of cell-free circulating tumor DNA
To measure the presence of cell-free circulating tumor DNA (ctDNA) with digital-droplet PCR to correlate the presence/absence of ctDNA with the risk of relapse or death measured by RFS, DMFS, OS.
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