A Clinical Study of the Pharmacokinetics 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-263-1 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.

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. 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 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.

    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.

    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.

    NCT06112808
    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 1
    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.

    Arina V Zinkina-Orikhan
    Principal Investigator Affiliation Director of Clinical Development Department, BIOCAD
    Agency Class

    Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

    Industry
    Overall Status Recruiting
    Countries Belarus, Russian Federation
    Conditions

    The disease, disorder, syndrome, illness, or injury that is being studied.

    Advanced Melanoma
    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

    Active Comparator: Opdivo

    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

    Minsk, Belarus

    Status

    Recruiting

    Address

    Healthcare Institution "Minsk City Clinical Cancer Center"

    Minsk, , 220013

    Site Contact

    Svetlana A Demidova

    [email protected]

    +375 17 237 32 90

    Minsk, Belarus

    Status

    Recruiting

    Address

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

    Minsk, , 223040

    Site Contact

    Olga Sergeeva

    [email protected]

    + 375172652301

    Chelyabinsk, Chelyabinsk Oblast, Russian Federation

    Status

    Recruiting

    Address

    Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine

    Chelyabinsk, Chelyabinsk Oblast, 454087

    Site Contact

    Natalya V Fadeeva, MD, PhD

    [email protected]

    +7 (351) 214 88 8

    LLC "New Clinic", Pyatigorsk, Stavropol Krai, Russian Federation

    Status

    Recruiting

    Address

    LLC "New Clinic"

    Pyatigorsk, Stavropol Krai, 357500

    Site Contact

    Victoria V Chistyakova

    [email protected]

    +7 (8793) 97 45 31

    Arkhangel'sk, Russian Federation

    Status

    Recruiting

    Address

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

    Arkhangel'sk, , 164523

    Site Contact

    Marina Nechaeva, MD

    [email protected]

    +7 (8184) 53-26-83

    Barnaul, Russian Federation

    Status

    Recruiting

    Address

    Regional State Budgetary Healthcare Institution "Altai Regional Oncological Dispensary"

    Barnaul, , 656045

    Site Contact

    Denis Tantsyrev

    [email protected]

    +7 (3852) 507 355

    Kaliningrad, Russian Federation

    Status

    Recruiting

    Address

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

    Kaliningrad, , 236016

    Site Contact

    Mikhail Agapov

    [email protected]

    +7 (4012) 59 55 95

    Kaliningrad, Russian Federation

    Status

    Recruiting

    Address

    Limited Liability Company "Ars Medica Centre"

    Kaliningrad, , 236022

    Site Contact

    Irina Grebtsova

    [email protected]

    +7 (4012) 777 057

    Kaluga, Russian Federation

    Status

    Recruiting

    Address

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

    Kaluga, , 248007

    Site Contact

    Irina Rozhkova

    [email protected]

    +7 (903) 81 11 911

    Kazan, Russian Federation

    Status

    Recruiting

    Address

    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, ,

    Site Contact

    Sufia Z Safina, MD

    [email protected]

    +7 (843) 202 3 202

    Kostroma, Russian Federation

    Status

    Recruiting

    Address

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

    Kostroma, , 156005

    Site Contact

    Anastasiya Nikiforova

    [email protected]

    +7 (4942) 37 37 37

    Moscow, Russian Federation

    Status

    Recruiting

    Address

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

    Moscow, , 115478

    Site Contact

    Kristina Orlova

    [email protected]

    +74993242424

    JSC "Medsi Group", Moscow, Russian Federation

    Status

    Recruiting

    Address

    JSC "Medsi Group"

    Moscow, ,

    Site Contact

    Anastasiia S Mochalova

    [email protected]

    +7 (495) 021 47 02

    Moscow City Oncology Hospital No. 62, Moscow, Russian Federation

    Status

    Recruiting

    Address

    Moscow City Oncology Hospital No. 62

    Moscow, ,

    Site Contact

    Daniil L Stroyakovsky, MD, PhD

    [email protected]

    +7 (495) 536 01 00

    Moscow, Russian Federation

    Status

    Recruiting

    Address

    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, ,

    Site Contact

    Marina A Lyadova

    [email protected]

    +7 (499) 261 30 42

    Moscow, Russian Federation

    Status

    Recruiting

    Address

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

    Moscow, ,

    Site Contact

    Karina Vorontsova, MD PhD

    [email protected]

    +7 (495) 304 30 39

    Nizhny Novgorod, Russian Federation

    Status

    Recruiting

    Address

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

    Nizhny Novgorod, , 603126

    Site Contact

    Irina S Shumskaya

    [email protected]

    +7 (831) 282 00 01

    Novosibirsk, Russian Federation

    Status

    Recruiting

    Address

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

    Novosibirsk, , 630108

    Site Contact

    Vadim Kozlov

    [email protected]

    +7 (383) 382 80 14

    Omsk, Russian Federation

    Status

    Recruiting

    Address

    State budget healthcare institution Omsk region "Clinical Oncology Dispensary"

    Omsk, ,

    Site Contact

    Anastasiya Zimina, MD

    [email protected]

    +7 (3812) 60 16 95

    JSC "Modern Medical Technologies", Saint Petersburg, Russian Federation

    Status

    Recruiting

    Address

    JSC "Modern Medical Technologies"

    Saint Petersburg, , 190013

    Site Contact

    Svetlana V Odintsova, MD

    [email protected]

    +7-(812)-2104028

    Saint Petersburg, Russian Federation

    Status

    Recruiting

    Address

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

    Saint Petersburg, , 195271

    Site Contact

    Aleksandr G Vasiliev

    [email protected]

    +7 (812) 67 97 003

    Saint Petersburg, Russian Federation

    Status

    Recruiting

    Address

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

    Saint Petersburg, ,

    Site Contact

    Vladimir Moiseyenko

    [email protected]

    +7 (812) 573 91 31

    Saint Petersburg, Russian Federation

    Status

    Recruiting

    Address

    Limited Liability Company "Oncological Research Center"

    Saint Petersburg, ,

    Site Contact

    Timur T Andabecov

    [email protected]

    +7 (812) 409 96 63

    Saint Petersburg, Russian Federation

    Status

    Recruiting

    Address

    Private Medical Institution Evromedservis

    Saint Petersburg, ,

    Site Contact

    Konstantin D Pen'kov

    [email protected]

    +7 (812) 400 00 70

    Saint-Petersburg, Russian Federation

    Status

    Recruiting

    Address

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

    Saint-Petersburg, ,

    Site Contact

    Svetlana Protsenko

    [email protected]

    +7 (812) 43-99-555

    Samara, Russian Federation

    Status

    Recruiting

    Address

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

    Samara, , 443031

    Site Contact

    Yulia Makarycheva

    [email protected]

    +7 (846) 994 61 96

    Saransk, Russian Federation

    Status

    Recruiting

    Address

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

    Saransk, ,

    Site Contact

    Pavel Skopin, PhD

    [email protected]

    +7 (8342) 24 37 32

    Limited Liability Company "Nebbiolo", Tomsk, Russian Federation

    Status

    Recruiting

    Address

    Limited Liability Company "Nebbiolo"

    Tomsk, , 634009

    Site Contact

    Polina Kazantseva

    [email protected]

    +7 (3822) 46 99 09

    Ufa, Russian Federation

    Status

    Recruiting

    Address

    Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan

    Ufa, , 450054

    Site Contact

    Oleg Lipatov

    [email protected]

    +7 (347) 216 3671

    Volgograd, Russian Federation

    Status

    Recruiting

    Address

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

    Volgograd, ,

    Site Contact

    Nadezhda V Kovalenko, MD

    [email protected]

    +7 (8442) 609 608

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