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

NCT06112808 | Active Not Recruiting Phase 1

• 1 other identifier: BCD-263-1
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 30

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.

Conditions

Advanced Melanoma

Outcome Measures

Primary Outcomes (1)

• AUC(0-672) of nivolumab

  To compare area under the drug concentration-time curve in the time interval from 0 to 672 hours after intravenous administration of BCD-263 and Opdivo

  pre-dose to week 25

Secondary Outcomes (18)

• Cmax

  week 25

• AUC(0-∞)

  week 25

• Tmax

  week 25

• T½

  week 25

• Kel

  week 25

Study Arms (2)

BCD-263

EXPERIMENTAL

Drug: BCD-263

Opdivo

ACTIVE COMPARATOR

Drug: Opdivo

Interventions

BCD-263 DRUG

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

Also known as: Nivolumab

BCD-263

Opdivo DRUG

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

Also known as: Nivolumab

Opdivo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years at the time of signing the informed consent form;
• Body weight 60 to 90 kg.
• 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.
• Newly diagnosed advanced unresectable (stage III) or metastatic disease (stage IV), or progressive disease during / relapsing after radical treatment.

You may not qualify if:

• Indications for radical treatment (surgery, radiation therapy).
• Uveal or mucosal melanoma.
• 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).
• Active CNS metastases and/or carcinomatous meningitis.
• 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).
• 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.
• Concomitant diseases and/or conditions that significantly increase the risk of adverse events (AEs) during the study.

Sponsors & Collaborators

• Biocad: lead

Study Sites (30)

Healthcare Institution "Minsk City Clinical Cancer Center"

Minsk, 220013, Belarus

Location

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

Minsk, 223040, Belarus

Location

Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine

Chelyabinsk, Chelyabinsk Oblast, 454087, Russia

Location

JSC "Modern Medical Technologies"

Saint Petersburg, Sankt-Peterburg, 190013, Russia

Location

LLC "New Clinic"

Pyatigorsk, Stavropol Kray, 357500, Russia

Location

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

Arkhangelsk, 164523, Russia

Location

Regional State Budgetary Healthcare Institution "Altai Regional Oncological Dispensary"

Barnaul, 656045, Russia

Location

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

Kaliningrad, 236016, Russia

Location

Limited Liability Company "Ars Medica Centre"

Kaliningrad, 236022, Russia

Location

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

Kaluga, 248007, Russia

Location

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

Location

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

Kostroma, 156005, Russia

Location

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

Moscow, 115478, Russia

Location

JSC "Medsi Group"

Moscow, Russia

Location

Moscow City Oncology Hospital No. 62

Moscow, Russia

Location

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

Location

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

Moscow, Russia

Location

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

Nizhny Novgorod, 603126, Russia

Location

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

Novosibirsk, 630108, Russia

Location

State budget healthcare institution Omsk region "Clinical Oncology Dispensary"

Omsk, Russia

Location

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

Saint Petersburg, 195271, Russia

Location

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

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

Limited Liability Company "Oncological Research Center"

Saint Petersburg, Russia

Location

Private Medical Institution Evromedservis

Saint Petersburg, Russia

Location

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

Samara, 443031, Russia

Location

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

Saransk, Russia

Location

Limited Liability Company "Nebbiolo"

Tomsk, 634009, Russia

Location

Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan

Ufa, 450054, Russia

Location

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

Volgograd, Russia

Location

MeSH Terms

Interventions

Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Arina V Zinkina-Orikhan

  Director of Clinical Development Department, BIOCAD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: May 29, 2023
• Primary Completion: January 31, 2024
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); RU (28)