RecruitingPhase 2

Neo IRENIE (NEOadjuvant Ipilimumab, RElatlimab, NIvolumab Evaluation)

Australia494 participantsStarted 2026-02-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc)
✕. Inhaled or intranasal corticosteroids (with minimal systemic absorption) may be continued if patient is on a stable dose
✕. Non-absorbed intra-articular steroid injections.
✕. Vitiligo
✕. Type I diabetes mellitus
✕. Residual autoimmune hypothyroidism on stable hormone replacement
✕. Resolved childhood asthma or atopy
✕. Psoriasis not requiring systemic treatment

What they're measuring

Pathological response rate

Timeframe: Week 6

Trial details

NCT IDNCT06999980

SponsorMelanoma Institute Australia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03

Contact for this trial

Monica Osorio

+612 9911 7296 Monica.Osorio@melanoma.org.au

View on ClinicalTrials.gov More Cutaneous Melanoma trials