Status:
ACTIVE_NOT_RECRUITING
A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma
Lead Sponsor:
Sandoz
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of GME751 compared with Keytruda® (pembrolizumab) in subjects with resected adv...
Detailed Description
Eligible subjects will be randomized in a 1:1:1 ratio to receive either GME751, Food and Drug Administration (FDA)-licensed pembrolizumab (Keytruda-US) or European Union (EU)-authorized pembrolizumab ...
Eligibility Criteria
Inclusion
- At least 18 years of age
- Advanced Melanoma
- Completely removed melanoma by surgery performed within 13 weeks of randomization
- Adequate organ function
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Exclusion
- Known history or evidence of ocular or uveal melanoma
- Known history of hypersensitivity (grade ≥3) to pembrolizumab or its excipients
- Known History of auto-immune disease
- Received live vaccine ≤30 days before the first study treatment
- Prior treatment with anti-PD-1 agents or agent against another stimulatory or co-inhibitory T cell receptor
- Active autoimmune disease that has necessitated chronic systemic treatment within 2 years before the first study treatment
- Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
May 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
322 Patients enrolled
Trial Details
Trial ID
NCT06153238
Start Date
May 15 2024
End Date
June 1 2026
Last Update
December 18 2025
Active Locations (52)
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1
Sandoz Investigational Site
Orange, California, United States, 92868
2
Sandoz Investigational Site
Clermont, Florida, United States, 34711
3
Sandoz Investigational Site
Orange City, Florida, United States, 32763
4
Sandoz Investigational Site
Banja Luka, Bosnia and Herzegovina