Spots Global Cancer Trial Database for A Clinical Study of the Pharmacokinetics and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin
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Trial Identification
Brief Title: A Clinical Study of the Pharmacokinetics and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin
Official Title: A Double-Blind, Randomized Clinical Study of the Pharmacokinetics and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin
Study ID: NCT06112808
Conditions
Study Description
Brief Summary: The aim of the study BCD-263-1 is to prove the comparability of the pharmacokinetics and similarity of the safety, immunogenicity and pharmacodynamic profiles of BCD-263 and Opdivo following intravenous administration to subjects with advanced unresectable or metastatic melanoma of the skin. The study will have randomized, double-blind design with parallel assignment.
Detailed Description: Following screening, subjects will be randomized to receive either BCD-263 or Opdivo in a 1:1 ratio and enter the main study period. During the main study period, subjects will receive therapy with BCD-263 or Opdivo, which will be administered intravenously until disease progression or signs of unacceptable toxicity develop (whichever occurs earlier). At Week 25, after completion of all scheduled procedures subjects in both groups will continue to receive open-label BCD-263 for up to a total of 2 years of therapy, or disease progression, or signs of unacceptable toxicity (whichever occurs first). Following discontinuation of the study therapy, the subjects will enter a follow-up period, during which data on overall survival will be collected through telephone contacts.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Healthcare Institution "Minsk City Clinical Cancer Center", Minsk, , Belarus
State Institution "Republic Scientific and Practical Centre for Oncology and Medical Radiology Named after N.N.Aleksandrov", Minsk, , Belarus
Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine, Chelyabinsk, Chelyabinsk Oblast, Russian Federation
LLC "New Clinic", Pyatigorsk, Stavropol Krai, Russian Federation
State Budgetary Institution of Healthcare of the Arkhangelsk Region "Severodvinsk City Hospital №2 of Emergency", Arkhangel'sk, , Russian Federation
Regional State Budgetary Healthcare Institution "Altai Regional Oncological Dispensary", Barnaul, , Russian Federation
Federal State Educational Institution of Higher Education "Baltic Federal University Named after Immanuel Kant", Kaliningrad, , Russian Federation
Limited Liability Company "Ars Medica Centre", Kaliningrad, , Russian Federation
State Budgetary Healthcare Institution of Kaluga Region "Kaluga Region Clinical Oncological Dispensary", Kaluga, , 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
Regional State Budgetary of Healthcare Insti-tution "Kostroma Clinical Oncology Dispensary", Kostroma, , Russian Federation
"Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation, 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 Healthcare Institution "Moscow Clinical Scientific Center funded by Moscow Health Department" (SBHI MCSC MHD), Moscow, , Russian Federation
Nizhny Novgorod Region State Budgetary Healthcare Institution "Nizhny Novgorod Regional Clinical Oncological Dispensary", Nizhny Novgorod, , Russian Federation
State Budgetary Healthcare Institution of Novosibirsk Region "Novosibirsk Region Clinical Oncological Dispensary", Novosibirsk, , Russian Federation
State budget healthcare institution Omsk region "Clinical Oncology Dispensary", Omsk, , Russian Federation
JSC "Modern Medical Technologies", Saint Petersburg, , Russian Federation
Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of Saint Petersburg", Saint Petersburg, , Russian Federation
"Saint Petersburg Clinical Research and Practice Center for Specialized Medical Care (Oncology)", Saint Petersburg, , Russian Federation
Limited Liability Company "Oncological Research Center", Saint Petersburg, , Russian Federation
Private Medical Institution Evromedservis, Saint Petersburg, , Russian Federation
Federal State Budgetary Institution "N.N. Petrov Research Institute of Oncology" of the Ministry of Healthcare of the Russian Federation, Saint-Petersburg, , Russian Federation
State-financed Health Institution "Samara Region Clinical Oncology Dispensary", Samara, , Russian Federation
Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva ", Saransk, , Russian Federation
Limited Liability Company "Nebbiolo", Tomsk, , Russian Federation
Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan, Ufa, , Russian Federation
State Health Care Institution "Volgograd Regional Clinical Oncology Dispensary № 1", Volgograd, , Russian Federation
Contact Details
Name: Arina V Zinkina-Orikhan
Affiliation: Director of Clinical Development Department, BIOCAD
Role: STUDY_DIRECTOR
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