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

PHASE1RecruitingINTERVENTIONAL
Enrollment

318

Participants

Timeline

Start Date

May 15, 2024

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2026

Conditions
Melanoma
Interventions
DRUG

GME751

400 mg Q6W, i.v. infusion, over 24 weeks period

DRUG

Keytruda - EU

400 mg Q6W, i.v. infusion, over 24 weeks period

DRUG

Keytruda - US

400 mg Q6W, i.v. infusion, over 24 weeks period

Trial Locations (62)

32763

RECRUITING

Sandoz Investigational Site, Orange City

34711

RECRUITING

Sandoz Investigational Site, Clermont

92868

RECRUITING

Sandoz Investigational Site, Orange

Unknown

RECRUITING

Sandoz Investigational Site, Banja Luka

RECRUITING

Sandoz Investigational Site, Mostar

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Sandoz Investigational Site, Sarajevo

RECRUITING

Sandoz Investigational Site, Tuzla

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Sandoz Investigational Site, Barretos

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Sandoz Investigational Site, Belo Horizonte

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Sandoz Investigational Site, Canoas

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Sandoz Investigational Site, Caxias do Sul

RECRUITING

Sandoz Investigational Site, Curitiba

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Sandoz Investigational Site, Florianópolis

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Sandoz Investigational Site, Fortaleza

RECRUITING

Sandoz Investigational Site, Itajaí

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Sandoz Investigational Site, Porto Alegre

RECRUITING

Sandoz Investigational Site, Porto Velho

RECRUITING

Sandoz Investigational Site, Salvador

RECRUITING

Sandoz Investigational Site, São José do Rio Preto

WITHDRAWN

Sandoz Investigational Site, Besançon

RECRUITING

Sandoz Investigational Site, Nantes

RECRUITING

Sandoz Investigational Site, Batumi

RECRUITING

Sandoz Investigational Site, Tbilisi

RECRUITING

Sandoz Investigational Site, Mainz

RECRUITING

Sandoz Investigational Site, Münster

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Sandoz Investigational Site, Tübingen

RECRUITING

Sandoz Investigational Site, Catanzaro

RECRUITING

Sandoz Investigational Site, Napoli

RECRUITING

Sandoz Investigational Site, Rozzano

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Sandoz Investigational Site, Klaipėda

RECRUITING

Sandoz Investigational Site, Vilnius

RECRUITING

Sandoz Investigational Site, George Town

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Sandoz Investigational Site, Johor Bahru

RECRUITING

Sandoz Investigational Site, Kuala Lumpur

RECRUITING

Sandoz Investigational Site, Kuching

RECRUITING

Sandoz Investigational Site, Malacca

RECRUITING

Sandoz Investigational Site, Putrajaya

RECRUITING

Sandoz Investigational Site, Mexico City

RECRUITING

Sandoz Investigational Site, Oaxaca City

RECRUITING

Sandoz Investigational Site, Veracruz

RECRUITING

Sandoz Investigational Site, Chisinau

RECRUITING

Sandoz Investigational Site, Skopje

RECRUITING

Sandoz Investigational Site, Bacolod

RECRUITING

Sandoz Investigational Site, Bucharest

RECRUITING

Sandoz Investigational Site, Cluj-Napoca

RECRUITING

Sandoz Investigational Site, Belgrade

RECRUITING

Sandoz Investigational Site, Kamenitz

RECRUITING

Sandoz Investigational Site, Niš

RECRUITING

Sandoz Investigational Site, Johannesburg

RECRUITING

Sandoz Investigational Site, Phoenix

RECRUITING

Sandoz Investigational Site, Seoul

RECRUITING

Sandoz Investigational Site, Badalona

RECRUITING

Sandoz Investigational Site, Barcelona

RECRUITING

Sandoz Investigational Site, Cáceres

RECRUITING

Sandoz Investigational Site, Madrid

RECRUITING

Sandoz Investigational Site, Murcia

RECRUITING

Sandoz Investigational Site, Santiago de Compostela

RECRUITING

Sandoz Investigational Site, Seville

RECRUITING

Sandoz Investigational Site, Valencia

RECRUITING

Sandoz Investigational Site, Zaragoza

RECRUITING

Sandoz Investigational Site, Ankara

RECRUITING

Sandoz Investigational Site, Yüreğir

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sandoz

INDUSTRY