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
Status: Recruiting
Location: See all (61) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Sandoz Investigational Site
RECRUITING
Orange
Florida
Sandoz Investigational Site
RECRUITING
Clermont
Sandoz Investigational Site
RECRUITING
Orange City
Other Locations
Bosnia and Herzegovina
Sandoz Investigational Site
RECRUITING
Banja Luka
Sandoz Investigational Site
RECRUITING
Mostar
Sandoz Investigational Site
RECRUITING
Sarajevo
Sandoz Investigational Site
RECRUITING
Tuzla
Brazil
Sandoz Investigational Site
RECRUITING
Barretos
Sandoz Investigational Site
RECRUITING
Belo Horizonte
Sandoz Investigational Site
RECRUITING
Canoas
Sandoz Investigational Site
RECRUITING
Caxias Do Sul
Sandoz Investigational Site
RECRUITING
Curitiba
Sandoz Investigational Site
RECRUITING
Florianópolis
Sandoz Investigational Site
RECRUITING
Fortaleza
Sandoz Investigational Site
RECRUITING
Itajaí
Sandoz Investigational Site
RECRUITING
Porto Alegre
Sandoz Investigational Site
RECRUITING
Porto Velho
Sandoz Investigational Site
RECRUITING
Salvador
Sandoz Investigational Site
RECRUITING
São José Do Rio Preto
France
Sandoz Investigational Site
WITHDRAWN
Besançon
Sandoz Investigational Site
RECRUITING
Nantes
Georgia
Sandoz Investigational Site
RECRUITING
Batumi
Sandoz Investigational Site
RECRUITING
Tbilisi
Germany
Sandoz Investigational Site
RECRUITING
Mainz
Sandoz Investigational Site
RECRUITING
Münster
Sandoz Investigational Site
RECRUITING
Tübingen
Italy
Sandoz Investigational Site
RECRUITING
Catanzaro
Sandoz Investigational Site
RECRUITING
Napoli
Sandoz Investigational Site
RECRUITING
Rozzano
Lithuania
Sandoz Investigational Site
RECRUITING
Klaipėda
Sandoz Investigational Site
RECRUITING
Vilnius
Malaysia
Sandoz Investigational Site
RECRUITING
George Town
Sandoz Investigational Site
RECRUITING
Johor Bahru
Sandoz Investigational Site
RECRUITING
Kuala Lumpur
Sandoz Investigational Site
RECRUITING
Kuching
Sandoz Investigational Site
RECRUITING
Malacca
Sandoz Investigational Site
RECRUITING
Putrajaya
Mexico
Sandoz Investigational Site
RECRUITING
Mexico City
Sandoz Investigational Site
RECRUITING
Oaxaca City
Sandoz Investigational Site
RECRUITING
Veracruz
Philippines
Sandoz Investigational Site
RECRUITING
Bacolod
Republic of Korea
Sandoz Investigational Site
RECRUITING
Seoul
Republic of Moldova
Sandoz Investigational Site
RECRUITING
Chisinau
Romania
Sandoz Investigational Site
RECRUITING
Bucharest
Sandoz Investigational Site
RECRUITING
Cluj-napoca
Serbia
Sandoz Investigational Site
RECRUITING
Belgrade
Sandoz Investigational Site
RECRUITING
Kamenitz
Sandoz Investigational Site
RECRUITING
Niš
South Africa
Sandoz Investigational Site
RECRUITING
Johannesburg
Sandoz Investigational Site
RECRUITING
Phoenix
Spain
Sandoz Investigational Site
RECRUITING
Badalona
Sandoz Investigational Site
RECRUITING
Barcelona
Sandoz Investigational Site
RECRUITING
Cáceres
Sandoz Investigational Site
RECRUITING
Madrid
Sandoz Investigational Site
RECRUITING
Murcia
Sandoz Investigational Site
RECRUITING
Santiago De Compostela
Sandoz Investigational Site
RECRUITING
Seville
Sandoz Investigational Site
RECRUITING
Valencia
Sandoz Investigational Site
RECRUITING
Zaragoza
Turkey
Sandoz Investigational Site
RECRUITING
Ankara
Sandoz Investigational Site
RECRUITING
Yüreğir
Contact Information
Primary
Clinical Disclosure Representative
sandoz.disclosure@sandoz.net
+49 8024 / 908 0
Time Frame
Start Date: 2024-05-15
Estimated Completion Date: 2026-07
Participants
Target number of participants: 318
Treatments
Experimental: GME751
Subjects will receive GME751 via intravenous (IV) infusion.
Active_comparator: Keytruda - EU
Subjects will receive Keytruda-EU via intravenous (IV) infusion.
Active_comparator: Keytruda - US
Subjects will receive Keytruda-US via intravenous (IV) infusion.
Related Therapeutic Areas
Sponsors
Leads: Sandoz