Clinical Trial

A Phase 2 Clinical Trial of Neoadjuvant Relatlimab and Nivolumab in High Risk, Clinical Stage II Cutaneous Melanoma

Study acronym: Neo ReNi II
Active, Not Recruiting Phase 2
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Summary
Neoadjuvant therapy is feasible in stage II melanoma, and the dual inhibition of the distinct LAG-3 and PD-1 checkpoint pathways with relatlimab and nivolumab has a synergistic effect in the tumour microenvironment leading to a pathological response after 2 doses of therapy.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2022-06-09; most recent amendment 2026-02-02.
Status change: Recruiting → Active, Not Recruiting 2025-11-16
Status change: Not Yet Recruiting → Recruiting 2023-08-28
Trial Details
NCT Number NCT05418972
Lead Sponsor Melanoma Institute Australia
Collaborators: Bristol-Myers Squibb
Conditions Stage II Melanoma
Enrollment 20 participants
Start Date 2023-08-14
Primary Completion 2025-12-11 (estimated)
Study Completion 2035-10 (estimated)
Updated on ClinicalTrials.gov 2026-02-05