25
Participants
Start Date
October 3, 2024
Primary Completion Date
May 13, 2025
Study Completion Date
May 13, 2025
FYB206
FYB206 (Keytruda biosimilar candidate - test product) 200 mg administered as an IV infusion over 30 minutes on Day 1 of each cycle combined with chemotherapy in the first year (treatment Cycles 1 to 17)
FYB206
Open-label treatment with FYB206 combined with chemotherapy (Cycles 18-34) to assure treatment continuation for trial patients up to a total of 2 years (a total of 34 treatment cycles)
Keytruda
Keytruda (reference product) 200 mg administered as an IV infusion over 30 minutes on Day 1 of each cycle combined with chemotherapy in the first year (treatment Cycles 1 to 17)
Formycon Investigative Site, Batumi
Formycon Investigative Site, Kutaisi
Formycon Investigative Site, Tbilisi
Formycon Investigative Site, George Town
Formycon Investigative Site, Kuala Lumpur
Formycon Investigative Site, Kuching
Formycon Investigative Site, Shah Alam
Formycon Investigative Site, Subang Jaya
Formycon Investigative Site, Adana
Formycon Investigative Site, Diyarbakır
Formycon Investigative Site, Istanbul
Formycon Investigative Site, Izmir
Formycon Investigative Site, Samsun
Lead Sponsor
Formycon AG
INDUSTRY