drugset / Trial / NCT06797297
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
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-02-24
- Primary completion
- 2026-03-31
- Completion
- 2027-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IBI363 | Protein / enzyme biologic | — | — |
| Comparator | Pembrolizumab | Monoclonal antibody | — | — |