Clinical Trial

A Phase II Study of Neoadjuvant Pembrolizumab & Lenvatinib for Resectable Stage III Melanoma

Study acronym: Neo PeLe
Active, Not Recruiting Phase 2
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Summary
In many cancers, early stage diagnosis and early treatment offers the best chance of a prolonged recurrence free- and overall survival. In stage III/IV resectable melanoma, an opportunity exists to improve outcomes with the addition of neoadjuvant and adjuvant systemic therapy as an adjunct to surgery. Neoadjuvant clinical trials for resectable but bulky stage III/IV melanoma allows for the efficient and rapid evaluation of drug activity in humans utilising multiple clinical endpoints of metabolic, radiological and pathological response; relapse-free survival; overall survival.
Protocol Amendment History 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2019-12-18; most recent amendment 2026-04-20.
Status change: Recruiting → Active, Not Recruiting 2024-02-12
Status change: Active, Not Recruiting → Recruiting 2022-10-26
Status change: Recruiting → Active, Not Recruiting 2021-11-21
Status change: Not Yet Recruiting → Recruiting 2020-11-11
Trial Details
NCT Number NCT04207086
Lead Sponsor Melanoma Institute Australia
Collaborators: Merck Sharp & Dohme LLC
Conditions Melanoma Stage III
Enrollment 21 participants
Start Date 2020-11-11
Primary Completion 2023-01-31 (estimated)
Study Completion 2033-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-23