A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma

Completed · Phase 1

Conditions studied: Melanoma

In brief

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 advanced melanoma requiring adjuvant treatment with pembrolizumab.

Key facts

Study ID

NCT06153238

Run by

Sandoz

People needed

322

Starts

2024-05-15

Expected to finish

2026-05-05

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sandoz Investigational Site — Clermont, Florida, United States
• Sandoz Investigational Site — Orange City, Florida, United States
• Sandoz Investigational Site — Banja Luka, Bosnia and Herzegovina
• Sandoz Investigational Site — Mostar, Bosnia and Herzegovina
• Sandoz Investigational Site — Sarajevo, Bosnia and Herzegovina
• Sandoz Investigational Site — Tuzla, Bosnia and Herzegovina
• Sandoz Investigational Site — Barretos, Brazil
• Sandoz Investigational Site — Belo Horizonte, Brazil
• Sandoz Investigational Site — Canoas, Brazil
• Sandoz Investigational Site — Caxias do Sul, Brazil
• Sandoz Investigational Site — Curitiba, Brazil
• Sandoz Investigational Site — Florianópolis, Brazil
• Sandoz Investigational Site — Fortaleza, Brazil
• Sandoz Investigational Site — Itajaí, Brazil
• Sandoz Investigational Site — Porto Alegre, Brazil
• Sandoz Investigational Site — Porto Velho, Brazil
• Sandoz Investigational Site — Salvador, Brazil
• Sandoz Investigational Site — São José do Rio Preto, Brazil
• Sandoz Investigational Site — Besançon, France
• Sandoz Investigational Site — Nantes, France
• Sandoz Investigational Site — Batumi, Georgia
• Sandoz Investigational Site — Tbilisi, Georgia
• Sandoz Investigational Site — Mainz, Germany
• Sandoz Investigational Site — Münster, Germany
• Sandoz Investigational Site — Orange, California, United States

Full record on ClinicalTrials.gov

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