Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT06112808

PHASE1

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

Sponsor: Biocad

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2023-05-29

Completion Date

2027-01

Last Updated

2025-07-08

Healthy Volunteers

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

Inclusion Criteria: 1. Age ≥18 years at the time of signing the informed consent form; 2. Body weight 60 to 90 kg. 3. Histologically confirmed melanoma with the following prognostic characteristics: * LDH \<ULN of local laboratory (enrollment of subjects with LDH \<2x ULN of local laboratory is allowed until the number of subjects with LDH \>ULN is 30% of the total population of randomized subjects. The Sponsor will inform when enrollment of subjects is limited by LDH level \<ULN of the local laboratory). * Absence, according to the Investigator, of clinically significant symptoms associated with the tumor. * Absence, according to the Investigator, of rapidly progressing metastatic melanoma. 4. Newly diagnosed advanced unresectable (stage III) or metastatic disease (stage IV), or progressive disease during / relapsing after radical treatment. Exclusion Criteria: 1. Indications for radical treatment (surgery, radiation therapy). 2. Uveal or mucosal melanoma. 3. Previous systemic anticancer therapy for advanced unresectable or metastatic skin melanoma (a history of neoadjuvant or adjuvant therapy is allowed, provided that the therapy was completed at least 12 weeks before randomization). 4. Active CNS metastases and/or carcinomatous meningitis. 5. Previous invasive cancer, excluding diseases treated with potentially curative therapy with no evidence of recurrence for 2 years from the start of this therapy (subjects with radically resected basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, cervical carcinoma in situ of the uterus and other carcinomas in situ may be included). 6. Subjects with severe concomitant disorders, life-threatening acute complications of the primary disease (including massive pleural, pericardial, or peritoneal effusions requiring intervention, pulmonary lymphangitis, bleeding or organ perforation) at the time of signing the informed consent and during the screening period. 7. Concomitant diseases and/or conditions that significantly increase the risk of adverse events (AEs) during the study.

Locations (30)

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, Russia

JSC "Modern Medical Technologies"

Saint Petersburg, Sankt-Peterburg, Russia

LLC "New Clinic"

Pyatigorsk, Stavropol Kray, Russia

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

Arkhangelsk, Russia

Regional State Budgetary Healthcare Institution "Altai Regional Oncological Dispensary"

Barnaul, Russia

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

Kaliningrad, Russia

Limited Liability Company "Ars Medica Centre"

Kaliningrad, Russia

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

Kaluga, Russia

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', Russia

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

Kostroma, Russia

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

Moscow, Russia

JSC "Medsi Group"

Moscow, Russia

Moscow City Oncology Hospital No. 62

Moscow, Russia

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, Russia

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

Moscow, Russia

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

Nizhny Novgorod, Russia

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

Novosibirsk, Russia

State budget healthcare institution Omsk region "Clinical Oncology Dispensary"

Omsk, Russia

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

Saint Petersburg, Russia

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

Saint Petersburg, Russia

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

Saint Petersburg, Russia

Limited Liability Company "Oncological Research Center"

Saint Petersburg, Russia

Private Medical Institution Evromedservis

Saint Petersburg, Russia

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

Samara, Russia

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

Saransk, Russia

Limited Liability Company "Nebbiolo"

Tomsk, Russia

Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan

Ufa, Russia

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

Volgograd, Russia

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (30)