Neo IRENIE (NEOadjuvant Ipilimumab, RElatlimab, NIvolumab Evaluation)

Sponsor
Melanoma Institute Australia
Study ID
NCT06999980
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cutaneous Melanoma
  • Mucosal Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
Feb 9, 2026
Status verified
Feb 2026
Primary completion
Mar 31, 2028
Completion
Jan 31, 2038

Study Design

Enrollment
494 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm A
    Ipilimumab at 3 mg per kg with nivolumab at 1 mg per kg will be administered on days 1 and 22 (Q3W) in the neoadjuvant period for a total of 2 doses.
  • Experimental: Treatment Arm B
    Ipilimumab 1mg per kg and the fixed dose combination nivolumab 480 mg and relatlimab 160 mg will be administered on days 1 and 29 (Q4W) for a total of 2 doses.
  • Experimental: Treatment Arm C
    Fixed dose combination of nivolumab 480 mg and relatlimab 160 mg alone, to be administered on days 1 and 29 (Q4W) for a total of 2 doses.
  • Active Comparator: Treatment Arm D (Cohort 1a)
    Ipilimumab at 1 mg per kg with nivolumab at 3 mg per kg will be administered on days 1 and 22 (Q3W) in the neoadjuvant period for a total of 2 doses.
  • Active Comparator: Treatment Arm E (Cohort 1b)
    Ipilimumab at 1 mg per kg with nivolumab at 3 mg per kg will be administered on days 1 and 22 (Q3W) in the neoadjuvant period for a total of 2 doses.
  • Active Comparator: Treatment Arm F
    Pembrolizumab 200 mg will be administered on days 1 and 22 (Q3W) in the neoadjuvant period for a total of 2 doses

Primary Outcome Measure

Pathological response rate [ Time Frame: Week 6 ]

Central Contacts

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