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

NCT ID: NCT06112808

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-29
• Study Completion Date: 2027-01-31

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.

Conditions

Advanced Melanoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BCD-263

Group Type: EXPERIMENTAL

BCD-263

Intervention Type: DRUG

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

Opdivo

Group Type: ACTIVE_COMPARATOR

Opdivo

Intervention Type: DRUG

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

Interventions

BCD-263

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

Intervention Type: DRUG

Opdivo

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

Intervention Type: DRUG

Other Intervention Names

Nivolumab; Nivolumab

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biocad

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arina V Zinkina-Orikhan

Role: STUDY_DIRECTOR

Director of Clinical Development Department, BIOCAD

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, 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

Countries

Belarus; Russia

Other Identifiers

BCD-263-1

Identifier Type: -

Identifier Source: org_study_id