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A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma
Sponsor: Sandoz
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 advanced melanoma requiring adjuvant treatment with pembrolizumab.
Official title: A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics of GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU Authorized Keytruda® in Participants With Stage II and III Melanoma Requiring Adjuvant Treatment With Pembrolizumab
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
322
Start Date
2024-05-15
Completion Date
2026-06
Last Updated
2026-02-05
Healthy Volunteers
No
Conditions
Interventions
GME751
400 mg Q6W, i.v. infusion, over 24 weeks period
Keytruda - EU
400 mg Q6W, i.v. infusion, over 24 weeks period
Keytruda - US
400 mg Q6W, i.v. infusion, over 24 weeks period
Locations (61)
Sandoz Investigational Site
Orange, California, United States
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
Tübingen, Germany
Sandoz Investigational Site
Catanzaro, Italy
Sandoz Investigational Site
Rozzano, Italy
Sandoz Investigational Site
Klaipėda, Lithuania
Sandoz Investigational Site
Vilnius, Lithuania
Sandoz Investigational Site
George Town, Malaysia
Sandoz Investigational Site
Johor Bahru, Malaysia
Sandoz Investigational Site
Kuala Lumpur, Malaysia
Sandoz Investigational Site
Kuching, Malaysia
Sandoz Investigational Site
Malacca, Malaysia
Sandoz Investigational Site
Putrajaya, Malaysia
Sandoz Investigational Site
Mexico City, Mexico
Sandoz Investigational Site
Oaxaca City, Mexico
Sandoz Investigational Site
San Luis Potosí City, Mexico
Sandoz Investigational Site
Veracruz, Mexico
Sandoz Investigational Site
Chisinau, Moldova
Sandoz Investigational Site
Skopje, North Macedonia
Sandoz Investigational Site
Bacolod, Philippines
Sandoz Investigational Site
Bucharest, Romania
Sandoz Investigational Site
Cluj-Napoca, Romania
Sandoz Investigational Site
Belgrade, Serbia
Sandoz Investigational Site
Kamenitz, Serbia
Sandoz Investigational Site
Niš, Serbia
Sandoz Investigational Site
Johannesburg, South Africa
Sandoz Investigational Site
Phoenix, South Africa
Sandoz Investigational Site
Badalona, Spain
Sandoz Investigational Site
Barcelona, Spain
Sandoz Investigational Site
Cáceres, Spain
Sandoz Investigational Site
Madrid, Spain
Sandoz Investigational Site
Murcia, Spain
Sandoz Investigational Site
Santiago de Compostela, Spain
Sandoz Investigational Site
Seville, Spain
Sandoz Investigational Site
Valencia, Spain
Sandoz Investigational Site
Zaragoza, Spain
Sandoz Investigational Site
Ankara, Turkey (Türkiye)
Sandoz Investigational Site
Yüreğir, Turkey (Türkiye)