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IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)

Study acronym: PRISM-MEL-301
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Study sites: 174 to 211v12
  2. Study sites: 150 to 174v11
  3. Study sites: 97 to 150
    • Interventions: Brenetafusp (Biological), Nivolumab (Biological), Nivolumab + Relatlimab (Biological) to Brenetafusp (Drug), Nivolumab (Drug), Nivolumab + Relatlimab (Drug)
    • Secondary endpoints: 8 to 9
    v10
  4. Primary completion date: Dec 1, 2026 to Oct 16, 2027v9 Show 5 more changesShow less
    • Start date: Dec 18, 2023 to Jun 5, 2024
    • Study sites: 82 to 97
    • Study completion date: Dec 1, 2027 to Oct 16, 2027
    • Interventions: IMC-F106C (Biological), Nivolumab (Biological), Nivolumab + Relatlimab (Biological) to Brenetafusp (Biological), Nivolumab (Biological), Nivolumab + Relatlimab (Biological)
    • Secondary endpoints: details revised at 1 of 8 entries
  5. Study sites: 73 to 82v8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 21 to 73v7
  2. Study sites: 4 to 21v6
  3. Study sites: 3 to 4v5
  4. Re-verified, no change to tracked fieldsv4
  5. Study sites: 59 to 3v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 62 to 59
    • Start date changed from estimate of Dec 1, 2023 to Dec 18, 2023
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Immunocore Ltd
7 trials monitored
See all monitored trials
Melanoma
1,092 trials monitored
See 60 trials at risk
This is a phase 3, randomized, controlled study of brenetafusp (IMC-F106C) plus nivolumab compared to standard nivolumab regimens in HLA-A\*02:01-positive participants with previously untreated advanced melanoma.
Trial Details
NCT Number NCT06112314
Lead Sponsor Immunocore Ltd
Conditions
(from sponsor)		 Advanced Melanoma
Enrollment 680 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov