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

NCT06640530 | Active Not Recruiting Phase 3

• 1 other identifier: BCD-263-2
• Study Type: interventional
• Target: 392
• Locations: 3 countries
• Sites: 44

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.

Conditions

Advanced Melanoma; Melanoma (Skin)

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR) according to RECIST 1.1

  To compare the overall response rates (ORRs) after administration of BCD-263 and Opdivo in subjects with advanced unresectable or metastatic skin melanoma

  Week 25

Secondary Outcomes (7)

• Time to response

  Week 25

• Duration of response

  week 25

• DCR

  week 25

• PFS

  week 25

• Overall survival

  week 25

Other Outcomes (13)

• AUC(0-∞) (optional)

  week 25

• AUC(0-672) of nivolumab (optional)

  week 25

• Cmax (optional)

  week 25

Study Arms (2)

BCD-263

EXPERIMENTAL

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

Drug: BCD-263

Opdivo

ACTIVE COMPARATOR

Opdivo will be administered during main period

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:

• Signed informed consent and the subject's ability to comply with the protocol requirements.
• Age ≥18 years at the time of signing the informed consent form.
• 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.
• Newly diagnosed advanced unresectable (stage III) or metastatic disease (stage IV), or progressive disease during / relapsing after radical treatment.
• Presence of a tumor sample (archived or new biopsy) that is suitable for evaluation for PD L1 expression in the Investigator's opinion.
• At least one measurable lesion as per RECIST 1.1 based on independent central review.
• ECOG score 0-1.
• Laboratory test results consistent with adequate functioning of systems and organs.

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.
• Active CNS metastases and/or carcinomatous meningitis.
• 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).
• 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.
• 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).
• 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.
• History of (non-infectious) pneumonitis requiring corticosteroid therapy or pneumonitis at the time of screening.
• 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.
• Concomitant use of drugs or medical devices studied in other clinical studies or their use within 28 days prior to randomization.
• Infections requiring therapy or systemic antibiotics within 14 days prior to randomization.
• Administration of a live and/or attenuated vaccine within 28 days prior to randomization.
• Positive HIV-1 or HIV-2 test.

Sponsors & Collaborators

• Biocad: lead

Study Sites (44)

Healthcare Institution "Brest Regional Oncological Dispensary"

Brest, Belarus

Location

Health Institution "Gomel Regional Clinical Oncology Center"

Homyel, Belarus

Location

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

Shaheed Zulfiqar Ali Bhutto Medical University

Islamabad, Pakistan

Location

Rehman Medical Institute

Peshawar, Pakistan

Location

Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine

Chelyabinsk, Chelyabinsk Oblast, 454087, Russia

Location

Clinical Oncologic Dispensary No. 1

Krasnodar, Krasnodar Kari, 350040, Russia

Location

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

Krasnoyarsk, Krasnoyarsk Krai, 660133, Russia

Location

JSC "Modern Medical Technologies"

Saint Petersburg, Sankt-Peterburg, 190013, Russia

Location

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

Saint Petersburg, Sankt-Peterburg, 197758, 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

Ivanovo Regional Oncology Center

Ivanovo, 153013, Russia

Location

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

Izhevsk, 426009, Russia

Location

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

Kaliningrad, 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

"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

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

Location

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

Nizhny Novgorod, 603126, Russia

Location

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

Novosibirsk, Russia

Location

State budget healthcare institution Omsk region "Clinical Oncology Dispensary"

Omsk, Russia

Location

Perm Region Oncology Dispensary

Perm, 614066, Russia

Location

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

Perm, Russia

Location

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

Rostov-on-Don, 314019, Russia

Location

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

Saint Petersburg, 195271, 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

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

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

Provincial health official body "Smolensk Regional Clinical Oncological Dispensary"

Smolensk, 214000, Russia

Location

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

Tomsk, Russia

Location

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

Tver', Russia

Location

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

Tyumen, 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

Sverdlovsk Regional Oncology Center

Yekaterinburg, Russia

Location

MeSH Terms

Conditions

Melanoma

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• 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 11, 2024
• First Posted: October 15, 2024
• Study Start: March 21, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (38); BE (4); PA (2)