Neo IRENIE (NEOadjuvant Ipilimumab, RElatlimab, NIvolumab Evaluation)

Recruiting now · Phase 2

Conditions studied: Cutaneous Melanoma, Mucosal Melanoma

In brief

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.

Key facts

Study ID

NCT06999980

Run by

Melanoma Institute Australia

People needed

494

Starts

2026-02-09

Expected to finish

2038-01-01

Last updated by the study team

2026-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Written informed consent
• 2. Male or female patients who are at least 18 years of age on the day of signing informed consent.
• 3. Clinically detectable disease, and/or RECIST version 1.1 defined disease, and/or disease confirmed on PET imaging.
• 4. Fully resectable disease defined as having no significant vascular, central nervous system or bony involvement. Only cases where a complete surgical resection leading to tumour free margins and which is safely achieved is considered "resectable".
• 5. Concurrent primary disease and lymph node metastases acceptable provided completely resectable.
• 6. Up to 3 in-transit metastases are permitted as long as these are fully resectable.
• 7. Tumour that is amenable to a newly obtained core biopsy for performance of the multi-omic predictive biomarker model
• 8. ECOG performance status of 0 to 1.
• 9. Adequate haematological, hepatic, renal and endocrine function
• 10. An anticipated life expectancy of >12 months.
• 11. Women of child bearing potential (WOCBP) must agree to avoid pregnancy or breast feeding for the duration of study treatment.
• Inclusion Criteria - Cohort 1 only
• a. Histologically confirmed diagnosis of cutaneous melanoma or unknown primary melanoma
• b. AJCC 8th Ed Stage IIIB, IIIC, IIID cutaneous melanoma
• c. No prior systemic treatment for cutaneous melanoma
• d. Completion of the multi-omic predictive biomarker model within 14 days (7-10 business days) of planned randomisation.
• Inclusion Criteria - Cohort 2 only
• a. Histologically confirmed diagnosis of cutaneous melanoma or unknown primary melanoma
• b. AJCC 8th Ed Stage IIIB, IIIC, IIID cutaneous melanoma
• c. Disease progression on neoadjuvant anti-PD-1 monotherapy, where progressed disease is completely resectable or, disease recurrence on adjuvant anti-PD-1 monotherapy, where recurrent disease is completely resectable
• d. No prior treatment with CTLA-4 or LAG-3 inhibitors.
• Inclusion Criteria - Cohort 3 only
• a. Histologically confirmed diagnosis of mucosal melanoma
• b. Any stage of disease provided it is fully resectable
• c. No prior systemic treatment for mucosal melanoma

Where it is running

• Melanoma Institute Australia — Wollstonecraft, New South Wales, Australia (enrolling)

Full record on ClinicalTrials.gov

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