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A Study to Evaluate the Efficacy and Safety of IBI363 Monotherapy Compared to Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic Mucosal or Acral Melanoma Who Had Not Previously Received Systemic Therapy

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 4, 2025 (before its estimated March 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Feb 7, 2025 to Feb 24, 2025 · Site details revised at 31 of 31 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Feb 7, 2025 to Feb 24, 2025
    • Site details revised at 31 of 31 sites
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a Phase II, open-label, randomized, multi-center study to assess the efficacy and safety of IBI363 monotherapy compared to Pembrolizumab in the treatment of patients with unresectable locally advanced or metastatic mucosal or acral melanoma who had not previously received systemic therapy.
Trial Details
NCT Number NCT06797297
Lead Sponsor Innovent Biologics (Suzhou) Co. Ltd.
Conditions Melanoma
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov