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

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT06797297
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IBI363 — BIOLOGICAL
    a mutated IL-2 cytokine fused to an anti-PD-1 antibody to combine IL-2 pathway stimulation with checkpoint blockade.
  • Pembrolizumab — BIOLOGICAL
    Pembrolizumab is a humanized monoclonal anti-PD1 antibody

Study Details

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.

Key Dates

Start date
Feb 24, 2025
Status verified
Apr 2025
Primary completion
Mar 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: IBI363
  • Active Comparator: Active Comparator: Pembrolizumab

Primary Outcome Measure

IRRC-Progression Free Survival(PFS) [ Time Frame: up to 2 years ]

Central Contacts

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