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A Phase 2 Clinical Trial of Neoadjuvant Relatlimab and Nivolumab in High Risk, Clinical Stage II Cutaneous Melanoma

Study acronym: Neo ReNi II
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Jan 2026 to Dec 11, 2025 Completion date: Jan 2036 to Oct 2035 · Secondary endpoints: 11 to 12v12 Show 2 more changesShow less
    • Completion date: Jan 2036 to Oct 2035
    • Secondary endpoints: 11 to 12

    See this version in full on ClinicalTrials.gov ↗

  2. Eligibility criteria expanded, about 196 words Secondary endpoints: 9 to 11v11 Show 1 more changeShow less
    • Secondary endpoints: 9 to 11

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Recruiting to Active, Not Recruiting Primary completion date: Dec 2025 to Jan 2026 · Completion date: Dec 2035 to Jan 2036 · Site details revisedv10 Show 3 more changesShow less
    • Primary completion date: Dec 2025 to Jan 2026
    • Completion date: Dec 2035 to Jan 2036
    • Site details revised
  4. Primary completion date: Dec 2024 to Dec 2025 Completion date: Dec 2034 to Dec 2035v9 Show 1 more changeShow less
    • Completion date: Dec 2034 to Dec 2035
  5. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 2023 to Aug 14, 2023 · Site details revisedv8 Show 2 more changesShow less
    • Start date changed from estimate of Apr 2023 to Aug 14, 2023
    • Site details revised
Show 6 earlier versionsHide 6 earlier versions
  1. Start date: Dec 2022 to Apr 2023v7
  2. Start date: Sep 2022 to Dec 2022 Primary completion date: Sep 2024 to Dec 2024 · Completion date: Sep 2034 to Dec 2034v6 Show 2 more changesShow less
    • Primary completion date: Sep 2024 to Dec 2024
    • Completion date: Sep 2034 to Dec 2034
  3. Primary completion date: Aug 2024 to Sep 2024 Completion date: Aug 2034 to Sep 2034 · Start date: Aug 2022 to Sep 2022v5 Show 2 more changesShow less
    • Completion date: Aug 2034 to Sep 2034
    • Start date: Aug 2022 to Sep 2022
  4. Re-verified, no change to tracked fieldsv4
  5. Site contact updatedv3
  6. Study description shortened, about 56 words Study title shortened, about 4 wordsv2 Show 1 more changeShow less
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  1. 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.
Neoadjuvant therapy is feasible in stage II melanoma, and the dual inhibition of the distinct LAG-3 and PD-1 checkpoint pathways with relatlimab and nivolumab has a synergistic effect in the tumour microenvironment leading to a pathological response after 2 doses of therapy.
Trial Details
NCT Number NCT05418972
Lead Sponsor Melanoma Institute Australia
Collaborators: Bristol-Myers Squibb
Conditions Stage II Melanoma
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov