RecruitingPhase 2NCT06999980

Neo IRENIE (NEOadjuvant Ipilimumab, RElatlimab, NIvolumab Evaluation)

A Phase II, Multicentre, Parallel Group, Open Label, Randomised Clinical Trial of Neoadjuvant Nivolumab and Ipilimumab Combined With Relatlimab for Patients With Resectable Advanced Melanoma Identified as Poor Responders to Immunotherapy

Sponsor

Melanoma Institute Australia

Enrollment

494 participants

Start Date

Feb 9, 2026

Study Type

INTERVENTIONAL

Conditions

Cutaneous Melanoma Mucosal Melanoma

Summary

This clinical trial is for patients with stage 3 cutaneous melanoma and patients with mucosal melanoma who are able to have surgery to remove all tumour deposits. To improve the chance that melanoma will not recurr, new experimental combinations of a type of treatment called immunotherapy will be given before surgery.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (Neo IRENIE) is testing a combination of three immunotherapy drugs — ipilimumab, relatlimab, and nivolumab — given before surgery (neoadjuvant) for people with melanoma, Merkel cell carcinoma, or cutaneous squamous cell carcinoma that can be surgically removed. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of melanoma (stage IIIB/IIIC/IIID), Merkel cell carcinoma, or cutaneous squamous cell carcinoma - Your cancer is considered fully removable by surgery - You have not received prior systemic treatment for melanoma (or meet specific criteria for the other cancer types) - You are in good general health (ECOG 0–1) - You have adequate blood, liver, kidney, and hormone function **You may NOT be eligible if...** - Your cancer cannot be completely removed by surgery - You have active autoimmune disease requiring treatment - You have had prior immunotherapy for your current cancer (varies by cohort) - You are pregnant or planning to become pregnant during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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