270
Participants
Start Date
August 2, 2022
Primary Completion Date
June 20, 2024
Study Completion Date
July 31, 2025
BCD-217
Subject recieves BCD-217 0.2 mL/kg, which is equivalent to 1 mg/kg nurulimab + 3 mg/kg prolgolimab, as an intravenous infusion once every 3 weeks (Q3W) simultaneously with placebo, a total of 4 intravenous infusions. Beginning with the 5th infusion, subjects are switched to prolgolimab 1 mg/kg monotherapy once every 2 weeks (Q2W).
BCD-100
Subject recieves prolgolimab 3 mg/kg as an intravenous infusion once every 3 weeks (Q3W) simultaneously with placebo, a total of 4 intravenous infusions. Beginning with the 5th infusion, subjects are switched to prolgolimab 1 mg/kg monotherapy once every 2 weeks (Q2W).
Placebo
Placebo
"State Regional Budgetary Healthcare Institution Regional Clinical Oncology Hospital of the Yaroslavl Region", Yaroslavl
"Regional Goverment Budgetary Healthcare State Kostroma Oncology Center", Kostroma
"LLC Clinical Trials", Saint Petersburg
"JSC Modern Medical Technologies", Saint Petersburg
"Healthcare Institution Minsk City Clinical Cancer Center", Minsk
Oncology Dispensary 2, Sochi
"LLC New Clinic", Pyatigorsk
Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine, Chelyabinsk
"Nizhny Novgorod Region State Budgetary Healthcare Facility Clinical Diagnostics Center", Nizhny Novgorod
"Healthcare Institution Bobruisk Interdistrict Oncological Dispensary", Babruysk
"Healthcare Institution Brest Regional Oncological Dispensary", Brest
"Health care institution Grodno University Clinic", Grodno
"Health Institution Gomel Regional Clinical Oncology Center", Homyel
"State Institution Republican Scientific and Practical Center of Oncology and Medical Radiology named after A.I. N.N. Alexandrov", Lesnoy
"State Institution Mogilev Regional Oncological Dispensary", Mogilev
"Healthcare Institution Vitebsk Regional Clinical Oncology Center", Vitebsk
Fortis Hospital, Faridabad
Kasturba Medical College and Hospital, Mangalore
TATA Memorial Hospital, Mumbai
HealthCare Global Enterprises Ltd, NCHRI Cancer Center, Nagpur
HealthCare Global Enterprises Ltd Manavata cancer Centre, Nashik
Sankalp Superspeciality Hospital, Nashik
All India Institute of Medical Science, New Delhi
Deenanath Mangeshkar Hospital & Research Center, Pune
PDEAS Ayurved Rugnalaya & Steriling Multispeciality Hospital, Pune
Horizon Mulitispeciality Hospital, Sangli
Shalby Hospital, Surat
Kiran Multispeciality hospital &Research, Sūrat
Arkhangelsk Clinical Oncology Dispensary, Arkhangelsk
"Regional State Budgetary Institution of Health Care Altai Regional Oncological Dispensary", Barnaul
"Limited Liability Company EVIMED", Chelyabinsk
"Private healthcare institution Clinical hospital RZD-Medicine of the city of Chelyabinsk", Chelyabinsk
State budgetary healthcare institution Leningrad Regional Clinical Hospital, Gatchina
"State Autonomous Health Institution Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigal", Kazan'
"State budgetary health care institution Kuzbass clinical oncological dispensary named after M.S. Rappoport", Kemerovo
"State Budgetary Institution of Healthcare Leningrad Regional Clinical Oncological Dispensary named after V.I. L.D. Romana", Kuz'molovskiy
"Russian Cancer Research Center named after N.N. Blokhin of the Ministry of Health of the Russian Federation", Moscow
Branch of Hadassah Medical LTD Limited Liability Company, Moscow
Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University), Moscow
"Joint Stock Company K31 City", Moscow
"JSC Medsi Group", Moscow
Moscow City Oncology Hospital No. 62, Moscow
"State budgetary health care institution of the city of Moscow City Clinical Oncology Hospital No. 1 of the Department of Health of the City of Moscow", Moscow
"State Budgetary Institution of Healthcare of the City of Moscow Moscow Multidisciplinary Clinical Center Kommunarka of the Department of Health of the City of Moscow", Moscow
"LLC DobroMed", Novosibirsk
"State Budgetary Healthcare Institution Novosibirsk Regional Clinical Oncology Center of the Novosibirsk Region", Novosibirsk
"Federal State Budgetary Institution National Medical Research Center for Radiology of the Ministry of Health of the Russian Federation", Obninsk
"Budgetary Healthcare Institution of Omsk Region Clinical Oncology Center", Omsk
"Federal State Budgetary Institution National Medical Research Center of Oncology named after N.N. Petrov of the Ministry of Health of the Russian Federation (FSBI N.N. Petrov National Medical Research Center of Oncology of the Ministry of Health of Ru", Pesochnyy
City Hospital #40, Kurortny district, Saint Petersburg
"Federal State Budgetary Educational Institution of Higher Education Saint Petersburg State University", Saint Petersburg
Federal State Budgetary Health Institution St. Petersburg Clinical Hospital of the Russian Academy of Sciences, Saint Petersburg
"Limited Liability Company EuroCityClinic", Saint Petersburg
"Limited Liability Company Oncological Research Center", Saint Petersburg
"Limited Liability Company Stepmed Clinic", Saint Petersburg
"Limited Liability Company Strategic Medical Systems", Saint Petersburg
"LLC AV medical group", Saint Petersburg
N.N. Petrov National Medicine Research Center of oncology, Saint Petersburg
Private Medical Institution Evromedservis, Saint Petersburg
"State budgetary health care institution St. Petersburg Clinical Scientific and Practical Center of Specialized Medical Assistance (Oncological)", Saint Petersburg
"Private institution educational organization of higher education Medical University Reaviz", Samara
"Federal State Educational Institution of Higher Professional Education Mordovia State University N.P. Ogareva ", Saransk
"State Health Care Institution Volgograd Regional Clinical Oncology Dispensary № 1", Volgograd
Lead Sponsor
Biocad
INDUSTRY