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 (Neo IRENIE)

NCT06999980 Phase 2 RECRUITING

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.

Details

Lead sponsor	Melanoma Institute Australia
Phase	Phase 2
Status	RECRUITING
Enrolment	494
Start date	2026-02-09
Completion	2038-01

Conditions

• Cutaneous Melanoma
• Mucosal Melanoma

Interventions

• Ipilimumab 3mg/kg and nivolumab 1mg/kg
• Ipilimumab 1mg/kg Nivolumab 480mg and relatlimab 160mg
• Nivolumab 480mg and relatlimab 160mg
• Ipilimumab 1mg/kg and nivolumab 3mg/kg
• Pembrolizumab 200 mg

Primary outcomes

• Pathological response rate — Week 6
  The primary endpoint is the pathological response rate at surgery (between days 43 and 56) from the first dose of neoadjuvant study treatment for each of cohorts 1b, 2 and 3. The pathological response is categorised thus: - Complete pathological response (pCR) - 0% viable tumour cells in the surgical specimen - Near complete pathological response - (near pCR) - \<10% viable tumour - Partial pathological response (pPR) - 10%-50% viable tumour - No pathological response (pNR) - \>50% viable tumour The proportion of participants with a pCR, or near pCR will determine the pathological response rate.

Countries

Australia