A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma
NCT ID: NCT06153238
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
322 participants
INTERVENTIONAL
2024-05-15
2026-06-30
Brief Summary
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Detailed Description
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Treatment duration is 24 weeks (4 treatment cycles, each of 6 weeks duration). However, subject should discontinue study participation in case of disease recurrence, unacceptable toxicity or other reasons.
Participants who are benefiting from treatment with pembrolizumab without signs of recurrence or unacceptable toxicity will be eligible for continued pembrolizumab treatment via most suitable option based on the respective country regulations.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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GME751
Subjects will receive GME751 via intravenous (IV) infusion.
GME751
400 mg Q6W, i.v. infusion, over 24 weeks period
Keytruda - EU
Subjects will receive Keytruda-EU via intravenous (IV) infusion.
Keytruda - EU
400 mg Q6W, i.v. infusion, over 24 weeks period
Keytruda - US
Subjects will receive Keytruda-US via intravenous (IV) infusion.
Keytruda - US
400 mg Q6W, i.v. infusion, over 24 weeks period
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Sandoz
INDUSTRY
Responsible Party
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Locations
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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
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Tuzla, , Bosnia and Herzegovina
Sandoz Investigational Site
Barretos, , Brazil
Sandoz Investigational Site
Belo Horizonte, , Brazil
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Canoas, , Brazil
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Caxias do Sul, , Brazil
Sandoz Investigational Site
Curitiba, , Brazil
Sandoz Investigational Site
Florianópolis, , Brazil
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Fortaleza, , Brazil
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Itajaí, , Brazil
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Porto Alegre, , Brazil
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Porto Velho, , Brazil
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São José do Rio Preto, , Brazil
Sandoz Investigational Site
Nantes, , France
Sandoz Investigational Site
Tbilisi, , Georgia
Sandoz Investigational Site
Mainz, , Germany
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Tübingen, , Germany
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Rozzano, , Italy
Sandoz Investigational Site
Klaipėda, , Lithuania
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Vilnius, , Lithuania
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George Town, , Malaysia
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Johor Bahru, , Malaysia
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Kuching, , Malaysia
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Putrajaya, , Malaysia
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Mexico City, , Mexico
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Oaxaca City, , Mexico
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San Luis Potosí City, , Mexico
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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
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)
Countries
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Other Identifiers
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CGME751A12101
Identifier Type: -
Identifier Source: org_study_id