Spots Global Cancer Trial Database for A Clinical Study of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma
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Trial Identification
Brief Title: A Clinical Study of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma
Official Title: A Double-Blind Placebo-Controlled Comparative Randomized Clinical Study of the Efficacy and Safety of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma
Study ID: NCT05732805
Study Description
Brief Summary: The aim of study is to investigate the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of BCD-217 followed by prolgolimab monotherapy versus prolgolimab monotherapy as first-line therapy in subjects with unresectable or metastatic melanoma.
Detailed Description: This study is designed as a phase III, randomized, double-blind, placebo-controlled study. After the stratification procedure, subjects are randomized in a 1:1 ratio into 2 groups: * BCD-217 + placebo (4 doses) → prolgolimab (BCD-217 group) * Prolgolimab + placebo (4 doses) → prolgolimab (BCD-100 monotherapy group)
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Healthcare Institution "Bobruisk Interdistrict Oncological Dispensary", Babruysk, , Belarus
Healthcare Institution "Brest Regional Oncological Dispensary", Brest, , Belarus
Health Institution "Gomel Regional Clinical Oncology Center", Gomel, , Belarus
Health care institution "Grodno University Clinic", Grodno, , Belarus
State Institution "Republican Scientific and Practical Center of Oncology and Medical Radiology named after A.I. N.N. Alexandrov", Lesnoy, , Belarus
Healthcare Institution "Minsk City Clinical Cancer Center", Minsk, , Belarus
State Institution "Mogilev Regional Oncological Dispensary", Mogilev, , Belarus
Healthcare Institution "Vitebsk Regional Clinical Oncology Center", Vitebsk, , Belarus
Fortis Hospital, Faridabad, , India
Kasturba Medical College and Hospital, Mangalore, , India
TATA Memorial Hospital, Mumbai, , India
HealthCare Global Enterprises Ltd, NCHRI Cancer Center, Nagpur, , India
HealthCare Global Enterprises Ltd Manavata cancer Centre, Nashik, , India
Sankalp Superspeciality Hospital, Nashik, , India
All India Institute of Medical Science, New Delhi, , India
Deenanath Mangeshkar Hospital & Research Center, Pune, , India
PDEAS Ayurved Rugnalaya & Steriling Multispeciality Hospital, Pune, , India
Horizon Mulitispeciality Hospital, Sangli, , India
Shalby Hospital, Surat, , India
Kiran Multispeciality hospital &Research, Sūrat, , India
Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine, Chelyabinsk, Chelyabinsk Oblast, Russian Federation
LLC "New Clinic", Pyatigorsk, Stavropol Krai, Russian Federation
Arkhangelsk Clinical Oncology Dispensary, Arkhangel'sk, , Russian Federation
Regional State Budgetary Institution of Health Care "Altai Regional Oncological Dispensary", Barnaul, , Russian Federation
Limited Liability Company "EVIMED", Chelyabinsk, , Russian Federation
Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of Chelyabinsk", Chelyabinsk, , Russian Federation
State budgetary healthcare institution Leningrad Regional Clinical Hospital, Gatchina, , Russian Federation
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, , Russian Federation
State budgetary health care institution "Kuzbass clinical oncological dispensary named after M.S. Rappoport", Kemerovo, , Russian Federation
Regional Goverment Budgetary Healthcare State "Kostroma Oncology Center", Kostroma, , Russian Federation
State Budgetary Institution of Healthcare "Leningrad Regional Clinical Oncological Dispensary named after V.I. L.D. Romana", Kuz'molovskiy, , Russian Federation
"Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation, Moscow, , Russian Federation
Branch of Hadassah Medical LTD Limited Liability Company, Moscow, , Russian Federation
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, , Russian Federation
Joint Stock Company "K31 City", Moscow, , Russian Federation
JSC "Medsi Group", Moscow, , Russian Federation
Moscow City Oncology Hospital No. 62, Moscow, , Russian Federation
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, , Russian Federation
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, , Russian Federation
Nizhny Novgorod Region State Budgetary Healthcare Facility "Clinical Diagnostics Center", Nizhny Novgorod, , Russian Federation
LLC "DobroMed", Novosibirsk, , Russian Federation
State Budgetary Healthcare Institution "Novosibirsk Regional Clinical Oncology Center" of the Novosibirsk Region, Novosibirsk, , Russian Federation
Federal State Budgetary Institution "National Medical Research Center for Radiology" of the Ministry of Health of the Russian Federation, Obninsk, , Russian Federation
Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Center", Omsk, , Russian Federation
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, , Russian Federation
LLC "Clinical Trials", Saint Petersburg, , Russian Federation
JSC "Modern Medical Technologies", Saint Petersburg, , Russian Federation
Federal State Budgetary Educational Institution of Higher Education "Saint Petersburg State University", Saint Petersburg, , Russian Federation
Federal State Budgetary Health Institution St. Petersburg Clinical Hospital of the Russian Academy of Sciences, Saint Petersburg, , Russian Federation
Limited Liability Company "EuroCityClinic", Saint Petersburg, , Russian Federation
Limited Liability Company "Oncological Research Center", Saint Petersburg, , Russian Federation
Limited Liability Company "Stepmed Clinic", Saint Petersburg, , Russian Federation
Limited Liability Company "Strategic Medical Systems", Saint Petersburg, , Russian Federation
LLC "AV medical group", Saint Petersburg, , Russian Federation
N.N. Petrov National Medicine Research Center of oncology, Saint Petersburg, , Russian Federation
Private Medical Institution Evromedservis, Saint Petersburg, , Russian Federation
Private institution educational organization of higher education "Medical University "Reaviz", Samara, , Russian Federation
State budgetary health care institution "St. Petersburg Clinical Scientific and Practical Center of Specialized Medical Assistance (Oncological)", Sankt Petersburg, , Russian Federation
Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva ", Saransk, , Russian Federation
Oncology Dispensary 2, Sochi, , Russian Federation
City Hospital #40, Kurortny district, St. Petersburg, , Russian Federation
State Health Care Institution "Volgograd Regional Clinical Oncology Dispensary № 1", Volgograd, , Russian Federation
State Regional Budgetary Healthcare Institution "Regional Clinical Oncology Hospital" of the Yaroslavl Region, Yaroslavl, , Russian Federation
Contact Details
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