117
Participants
Start Date
July 1, 2019
Primary Completion Date
July 31, 2023
Study Completion Date
December 31, 2023
BCD-217
Combination of anti-CTLA-4 and anti-PD-1 monoclonal antibodies, 1mg/kg and 3 mg/mg, respectively, given Q3W as IV infusion for first 4 blinded infusions
BCD-100
Anti-PD-1 monoclonal antibody, 3 mg/kg, given Q3W as IV infusion for first 4 blinded infusions, after - 1 mg/kg, given Q2W as IV infusion
Placebo
Placebo
Medsi Group of Companies Joint-Stock Company, Moscow
Regional Clinical Oncology Hospital, Yaroslavl
"State Budgetary Healthcare Institution of the Ar-khangelsk Region Arkhangelsk Clinical Oncology Dispensary", Arkhangelsk
Murmansk Regional Clinical Hospital named after P.A. Bayandina, Murmansk
"JSC Modern Medical Technologies", Saint Petersburg
AV Medical Group Limited Liability Company, Saint Petersburg
"Federal State Institution N.N. Petrov National Medical Research Center for Oncology", Saint Petersburg
Saint-Petersburg Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological), Saint Petersburg
"Federal State Budgetary Educational Institution of Higher Education St. Petersburg State University", Saint Petersburg
"Healthcare Institution Minsk Municipal Clinical Oncolo-gy Dispensary (MMCOD)", Minsk
Clinical Oncologic Dispensary No. 2, Sochi
"LLC New Clinic", Pyatigorsk
"State-financed Health Institution Samara Region Clinical Oncology Dispansary", Samara
"State Budgetary Healthcare Institution Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine,", Chelyabinsk
"State Budgetary Healthcare Institution of the Novosi-birsk Region Novosibirsk Regional Clinical Oncolo-gy Dispensary", Novosibirsk
"Territorial State Budgetary Healthcare Institution Altai Territorial Clinical Oncology Dispensary", Barnaul
Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I. Kryzhanovsky, Krasnoyarsk
"State Institution N.N. Aleksandrov Republican Research and Practical Center for Oncology and Medical Radiology", The Settlement of Lesnoy
"State public health institution Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan", Kazan'
"Regional State Budgetary of Healthcare Insti-tution Kostroma Oncology Dispensary", Kostroma
"Russian Cancer Research Center named after N.N. Blokhin of the Ministry of Health of the Russian Federation", Moscow
"State Health Care Institution Moscow City Oncology Hospital № 62 Moscow Health Department", Moscow
"State budget healthcare institution Omsk region Clinical Oncology Dispensary", Omsk
Lead Sponsor
Biocad
INDUSTRY