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	Recruiting
Countries	Belarus, Pakistan, Russian Federation
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, Belarus

Status

Recruiting

Address

Healthcare Institution "Brest Regional Oncological Dispensary"

Brest, ,

Site Contact

Vitalii S Volkov

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