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

NCT ID: NCT06640530

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 392 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-21
• Study Completion Date: 2027-03-31

Brief Summary

The aim of the study BCD-263-2/UNIVERSE is to demonstrate comparable efficacy and similar safety and immunogenicity profile of BCD-263 and Opdivo after repeated intravenous doses in subjects with advanced unresectable or metastatic melanoma of the skin.

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; Melanoma (Skin)

Study Design

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

Study Groups

BCD-263

BCD-263 will be administered during main period and open-label period

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

Opdivo will be administered during main period

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. Signed informed consent and the subject's ability to comply with the protocol requirements.

2. Age ≥18 years at the time of signing the informed consent form.

3. Histologically confirmed melanoma with the following prognostic characteristics:

• LDH <ULN of local laboratory (enrollment of subjects with LDH <2 x 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.

5. Presence of a tumor sample (archived or new biopsy) that is suitable for evaluation for PD L1 expression in the Investigator's opinion.

6. At least one measurable lesion as per RECIST 1.1 based on independent central review.

7. ECOG score 0-1.

8. Laboratory test results consistent with adequate functioning of systems and organs.

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.

4. Active CNS metastases and/or carcinomatous meningitis.

5. Previous invasive cancer, excluding diseases treated with potentially radical 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.

8. Active, known or suspected autoimmune disorders (subjects with type 1 diabetes mellitus or hypothyroidism requiring only hormone-replacement therapy and those with skin disorders [vitiligo, alopecia, or psoriasis] not requiring systemic therapy are eligible to participate).

9. The need for systemic corticosteroids (at doses equivalent to >10 mg/day prednisolone) or any other immunosuppressive drugs within 14 days prior to randomization. The use of inhaled and topical corticosteroids is allowed.

10. History of (non-infectious) pneumonitis requiring corticosteroid therapy or pneumonitis at the time of screening.

11. Any anticancer therapy or major surgery within 28 days prior to randomization, or the subject's AE (other than alopecia) caused by anticancer therapy has not yet recovered to CTCAE grade 1 or has not completely resolved.

12. Concomitant use of drugs or medical devices studied in other clinical studies or their use within 28 days prior to randomization.

13. Infections requiring therapy or systemic antibiotics within 14 days prior to randomization.

14. Administration of a live and/or attenuated vaccine within 28 days prior to randomization.

15. Positive HIV-1 or HIV-2 test.

16. HBV/HCV infections (subjects with a negative PCR result for hepatitis C virus RNA, without significant abnormalities in blood chemistry tests, examined by an infectious disease specialist and not requiring specific antiviral treatment at the time of screening, may be included in the study. Subjects with a positive HbsAg test result cannot be included in the study).

17. Impossibility to administer intravenous contrast agents (including due to hypersensitivity to contrast media).

18. Hypersensitivity or allergy to any of the nivolumab product components. Hypersensitivity or allergy to medicinal products obtained based on Chinese hamster ovary cells, or history of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies or hybrid proteins.

19. Pregnancy or breastfeeding, as well as intention to become pregnant or father a child during the study period.

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

Sponsors

Biocad

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Healthcare Institution "Brest Regional Oncological Dispensary"

Brest, , Belarus

Health Institution "Gomel Regional Clinical Oncology Center"

Homyel, , Belarus

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

Shaheed Zulfiqar Ali Bhutto Medical University

Islamabad, , Pakistan

Rehman Medical Institute

Peshawar, , Pakistan

Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine

Chelyabinsk, Chelyabinsk Oblast, Russia

Clinical Oncologic Dispensary No. 1

Krasnodar, Krasnodar Kari, Russia

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

Krasnoyarsk, Krasnoyarsk Krai, Russia

JSC "Modern Medical Technologies"

Saint Petersburg, Sankt-Peterburg, Russia

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

Saint Petersburg, Sankt-Peterburg, 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

Ivanovo Regional Oncology Center

Ivanovo, , Russia

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

Izhevsk, , Russia

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

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

"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

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, , Russia

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

Nizhny Novgorod, , Russia

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

Novosibirsk, , Russia

State budget healthcare institution Omsk region "Clinical Oncology Dispensary"

Omsk, , Russia

Perm Region Oncology Dispensary

Perm, , Russia

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

Perm, , Russia

Federal Government Budgetary Institution "National Institute of Cancer Research" of Ministry of Health of Russian Federation

Rostov-on-Don, , Russia

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

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

JSC "North-West Centre of Evidence-Based Mediccine"

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

Provincial health official body "Smolensk Regional Clinical Oncological Dispensary"

Smolensk, , Russia

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

Tomsk, , Russia

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

Tver', , Russia

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

Tyumen, , 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

Sverdlovsk Regional Oncology Center

Yekaterinburg, , Russia

Countries

Belarus; Pakistan; Russia

Other Identifiers

BCD-263-2

Identifier Type: -

Identifier Source: org_study_id