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Neo IRENIE (NEOadjuvant Ipilimumab, RElatlimab, NIvolumab Evaluation)

Study acronym: Neo IRENIE
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jan 2026 to Feb 9, 2026 · Site details revisedv7 Show 2 more changesShow less
    • Start date changed from estimate of Jan 2026 to Feb 9, 2026
    • Site details revised
  2. Enrollment target: 531 to 494 Primary completion date: Dec 2027 to Mar 2028 · Completion date: Sep 2037 to Jan 2038 · Start date: Dec 2025 to Jan 2026 · 1 morev6 Show 4 more changesShow less
    • Primary completion date: Dec 2027 to Mar 2028
    • Completion date: Sep 2037 to Jan 2038
    • Start date: Dec 2025 to Jan 2026
    • Study description expanded, about 20 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study title shortened, about 30 wordsv5 See this version in full on ClinicalTrials.gov ↗
  4. Enrollment target: 297 to 531 Start date: Sep 2025 to Dec 2025 · Primary completion date: Sep 2027 to Dec 2027 · Interventions: Ipilimumab 3mg/kg and nivolumab 1mg/kg (Drug), Nivolumab 480mg and relatlimab 160mg (Drug), Nivolumab 480mg and relatlimab 160mg and… to Ipilimumab 1mg/kg Nivolumab 480mg and relatlimab 160mg (Drug), Ipilimumab 1mg/kg and nivolumab 3mg/kg (Drug), Ipilimumab 3mg/kg and… · 5 morev4 Show 8 more changesShow less
    • Start date: Sep 2025 to Dec 2025
    • Primary completion date: Sep 2027 to Dec 2027
    • Interventions: Ipilimumab 3mg/kg and nivolumab 1mg/kg (Drug), Nivolumab 480mg and relatlimab 160mg (Drug), Nivolumab 480mg and relatlimab 160mg and… to Ipilimumab 1mg/kg Nivolumab 480mg and relatlimab 160mg (Drug), Ipilimumab 1mg/kg and nivolumab 3mg/kg (Drug), Ipilimumab 3mg/kg and…
    • Secondary endpoints: details revised at 1 of 10 entries
    • Study arms: 3 to 6
    • Study description shortened, about 1 word
    • Collaborators expanded, about 2 words
    • Study title expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Aug 2027 to Sep 2027 Completion date: Aug 2037 to Sep 2037 · Start date: Aug 2025 to Sep 2025v3 Show 2 more changesShow less
    • Completion date: Aug 2037 to Sep 2037
    • Start date: Aug 2025 to Sep 2025
  6. Study description expanded, about 2 words Study title shortened, about 3 wordsv2 Show 1 more changeShow less
    • Study title shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06999980
Lead Sponsor Melanoma Institute Australia
Collaborators: Bristol-Myers Squibb
Conditions Cutaneous Melanoma, Mucosal Melanoma
Enrollment 494 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov