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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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 is 30% of the total population of randomized subjects.

The Sponsor will inform when enrollment of subjects is limited by LDH level

- 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06640530
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Biocad
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Active, not recruiting
Countries	Belarus, Pakistan, Russia
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Advanced Melanoma, Melanoma (Skin)

Additional Details

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.

Arms & Interventions

Arms

Experimental: BCD-263

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

Active Comparator: Opdivo

Opdivo will be administered during main period

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Brest 629634, Belarus

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Healthcare Institution "Brest Regional Oncological Dispensary"

Brest 629634, ,

Homyel 627907, Belarus

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Health Institution "Gomel Regional Clinical Oncology Center"

Homyel 627907, ,

Minsk 625144, Belarus

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Healthcare Institution "Minsk City Clinical Cancer Center"

Minsk 625144, , 220013

Minsk 625144, Belarus

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

Minsk 625144, , 223040

Islamabad 1176615, Pakistan

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Shaheed Zulfiqar Ali Bhutto Medical University

Islamabad 1176615, ,

Rehman Medical Institute, Peshawar 1168197, Pakistan

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Rehman Medical Institute

Peshawar 1168197, ,

Chelyabinsk 1508291, Chelyabinsk Oblast 1508290, Russia

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Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine

Chelyabinsk 1508291, Chelyabinsk Oblast 1508290, 454087

Clinical Oncologic Dispensary No. 1, Krasnodar 542420, Krasnodar Kari, Russia

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Clinical Oncologic Dispensary No. 1

Krasnodar 542420, Krasnodar Kari, 350040

Krasnoyarsk 1502026, Krasnoyarsk Krai 1502020, Russia

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

Krasnoyarsk 1502026, Krasnoyarsk Krai 1502020, 660133

JSC "Modern Medical Technologies", Saint Petersburg 498817, Sankt-Peterburg 536203, Russia

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JSC "Modern Medical Technologies"

Saint Petersburg 498817, Sankt-Peterburg 536203, 190013

Saint Petersburg 498817, Sankt-Peterburg 536203, Russia

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

Saint Petersburg 498817, Sankt-Peterburg 536203, 197758

Arkhangelsk 581049, Russia

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

Arkhangelsk 581049, , 164523

Barnaul 1510853, Russia

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Regional State Budgetary Healthcare Institution "Altai Regional Oncological Dispensary"

Barnaul 1510853, , 656045

Ivanovo Regional Oncology Center, Ivanovo 555312, Russia

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Ivanovo Regional Oncology Center

Ivanovo 555312, , 153013

Izhevsk 554840, Russia

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

Izhevsk 554840, , 426009

Kaliningrad 554234, Russia

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

Kaliningrad 554234, ,

Kaluga 553915, Russia

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

Kaluga 553915, , 248007

Kazan' 551487, Russia

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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' 551487, ,

Moscow 524901, Russia

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

Moscow 524901, , 115478

JSC "Medsi Group", Moscow 524901, Russia

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JSC "Medsi Group"

Moscow 524901, ,

Moscow City Oncology Hospital No. 62, Moscow 524901, Russia

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Moscow City Oncology Hospital No. 62

Moscow 524901, ,

Moscow 524901, Russia

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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 524901, ,

Moscow 524901, Russia

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

Moscow 524901, ,

Moscow 524901, Russia

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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 524901, ,

Nizhny Novgorod 520555, Russia

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

Nizhny Novgorod 520555, , 603126

Novosibirsk 1496747, Russia

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

Novosibirsk 1496747, ,

Omsk 1496153, Russia

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State budget healthcare institution Omsk region "Clinical Oncology Dispensary"

Omsk 1496153, ,

Perm Region Oncology Dispensary, Perm 511196, Russia

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Perm Region Oncology Dispensary

Perm 511196, , 614066

Perm 511196, Russia

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

Perm 511196, ,

Rostov-on-Don 501175, Russia

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

Rostov-on-Don 501175, , 314019