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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

NCT06797297 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-04-04

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

IBI363

a mutated IL-2 cytokine fused to an anti-PD-1 antibody to combine IL-2 pathway stimulation with checkpoint blockade.

BIOLOGICAL

Pembrolizumab

Pembrolizumab is a humanized monoclonal anti-PD1 antibody

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-24
Primary Completion
2026-03-31
Completion
2027-06-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06797297 on ClinicalTrials.gov