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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

May 29, 2023

Primary Completion Date

January 31, 2024

Study Completion Date

January 31, 2027

Conditions
Advanced Melanoma
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 (30)

115478

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

156005

"Regional State Budgetary of Healthcare Insti-tution Kostroma Clinical Oncology Dispensary", Kostroma

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

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

236016

"Federal State Educational Institution of Higher Education Baltic Federal University Named after Immanuel Kant", Kaliningrad

236022

"Limited Liability Company Ars Medica Centre", Kaliningrad

248007

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

357500

"LLC New Clinic", Pyatigorsk

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

630108

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

634009

"Limited Liability Company Nebbiolo", Tomsk

656045

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

Unknown

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

"Saint Petersburg Clinical Research and Practice Center for Specialized Medical Care (Oncology)", Saint Petersburg

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

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

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biocad

INDUSTRY

NCT06112808 - A Clinical Study of the Pharmacokinetics and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin | Biotech Hunter | Biotech Hunter