Clinical Trial

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

Recruiting Phase 2
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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.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-01-27.
Status change: Not Yet Recruiting → Recruiting 2025-04-01
Trial Details
NCT Number NCT06797297
Lead Sponsor Innovent Biologics (Suzhou) Co. Ltd.
Conditions Melanoma
Enrollment 180 participants
Start Date 2025-02-24
Primary Completion 2026-03-31 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-04-04