Clinical Study of the Efficacy and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

392

Participants

Timeline

Start Date

March 21, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

March 31, 2027

Conditions
Advanced MelanomaMelanoma (Skin)
Interventions
DRUG

BCD-263

BCD-263 at a dose 480 mg administered intravenously every 4 weeks up to 6 cycles

DRUG

Opdivo

Opdivo at a dose 480 mg administered intravenously every 4 weeks up to 6 cycles

Trial Locations (44)

115478

"Russian Cancer Research Center named after N.N. Blokhin of the Ministry of Health of the Russian Federation", Moscow

153013

Ivanovo Regional Oncology Center, Ivanovo

164523

"State Budgetary Institution of Healthcare of the Arkhangelsk Region Severodvinsk City Hospital №2 of Emergency", Arkhangelsk

190013

"JSC Modern Medical Technologies", Saint Petersburg

195271

"Private healthcare institution Clinical hospital RZD-Medicine of the city of Saint Petersburg", Saint Petersburg

197758

Saint-Petersburg Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological), Saint Petersburg

214000

"Provincial health official body Smolensk Regional Clinical Oncological Dispensary", Smolensk

220013

"Healthcare Institution Minsk City Clinical Cancer Center", Minsk

223040

"State Institution Republic Scientific and Practical Centre for Oncology and Medical Radiology Named after N.N.Aleksandrov", Minsk

248007

"State Budgetary Healthcare Institution of Kaluga Region Kaluga Region Clinical Oncological Dispensary", Kaluga

314019

"Federal Government Budgetary Institution National Institute of Cancer Research of Ministry of Health of Russian Federation", Rostov-on-Don

350040

Clinical Oncologic Dispensary No. 1, Krasnodar

426009

"State Health Care Institution Republican Clinical Cancer Center, the Ministry of Health of the Udmurt Republic", Izhevsk

443031

"State-financed Health Institution Samara Region Clinical Oncology Dispensary", Samara

450054

Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan, Ufa

454087

Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine, Chelyabinsk

603126

"Nizhny Novgorod Region State Budgetary Healthcare Institution Nizhny Novgorod Regional Clinical Oncological Dispensary", Nizhny Novgorod

614066

Perm Region Oncology Dispensary, Perm

656045

"Regional State Budgetary Healthcare Institution Altai Regional Oncological Dispensary", Barnaul

660133

Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I. Kryzhanovsky, Krasnoyarsk

Unknown

"Healthcare Institution Brest Regional Oncological Dispensary", Brest

"Health Institution Gomel Regional Clinical Oncology Center", Homyel

Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad

Rehman Medical Institute, Peshawar

"State Budgetary Health Institution Regional Clinical Hospital of Kaliningrad Region", Kaliningrad

"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'

"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 Healthcare Institution Moscow Clinical Scientific Center funded by Moscow Health Department (SBHI MCSC MHD)", 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

"State Budgetary Healthcare Institution Novosibirsk Regional Clinical Oncology Center of the Novosibirsk Region", Novosibirsk

"State budget healthcare institution Omsk region Clinical Oncology Dispensary", Omsk

"State Budgetary Healthcare Institution of Perm Krai Order of Honour Perm Regional Clinical Hospital ", Perm

"Federal State Budgetary Institution N.N. Petrov Research Institute of Oncology of the Ministry of Healthcare of the Russian Federation", Saint Petersburg

"JSC North-West Centre of Evidence-Based Mediccine", Saint Petersburg

"Limited Liability Company Oncological Research Center", Saint Petersburg

Private Medical Institution Evromedservis, Saint Petersburg

"Federal State Educational Institution of Higher Professional Education Mordovia State University N.P. Ogareva ", Saransk

"Federal State Budgetary Educational Institution of Higher Education Siberian State Medical University of the Ministry of Health of the Russian Federation", Tomsk

"Federal State Budgetary Institution of Health Tver Regional Clinical Oncological Dispensary of the Tver Region", Tver'

"State Autonomus Institution of Health Mulitiprofile Clinical Medical Centre Medical City", Tyumen

"State Health Care Institution Volgograd Regional Clinical Oncology Dispensary № 1", Volgograd

Sverdlovsk Regional Oncology Center, Yekaterinburg

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biocad

INDUSTRY

NCT06640530 - Clinical Study of the Efficacy and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin | Biotech Hunter | Biotech Hunter