A Clinical Study of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma

Study Purpose

The aim of study is to investigate the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of BCD-217 followed by prolgolimab monotherapy versus prolgolimab monotherapy as first-line therapy in subjects with unresectable or metastatic melanoma.

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 requirements of the clinical study protocol; 2. Age ≥18 years at the time of signing the informed consent form; 3. Histologically confirmed melanoma (with available documented evidence of relevant investigations); 4. Untreated unresectable stage III melanoma or untreated metastatic (stage IV) melanoma; 5. Available blocks for histological examination and/or the subject's consent to undergo biopsy ; 6. Consent to the evaluation of the PD-L1 status and BRAF V600 mutation status at a central laboratory; 7. ECOG score 0-1; 8. Life expectancy of at least 12 weeks ; 9. Measurable target tumor lesions (at least 1 lesion) according to RECIST 1.1 criteria , confirmed by central independent reviewer; 10. In subjects of childbearing potential, willingness to use reliable contraceptive measures throughout the study, from the signing of the informed consent form and for additional 24 weeks after the administration of the last dose of the investigational product.

Exclusion Criteria:

1. Indications for radical (surgical, radiation) therapy; 2. A history of previous systemic antitumor therapy for unresectable or metastatic melanoma ; 3. Prior therapy with checkpoint inhibitors (e.g., anti-CTLA-4 and/or anti-PD-1/PD-L1/PD-L2 products); 4. Prior therapy with BRAF and MEK protein kinase inhibitors; 5. Use of immunostimulants, monoclonal antibodies and/or colony-stimulating factors within less than 4 weeks prior to randomization in the study; 6. Ocular melanoma; 7. Mucosal melanoma; 8. CNS metastases; 9. Impossibility to determine PD-L1 status and/or BRAF status; 10. Subjects with severe comorbidities, 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 form; 11. Ongoing concomitant diseases at the time of screening, which increase the risk of severe adverse events during the administration of the study therapy:

- stable angina, functional class III-IV; - unstable angina or a history of myocardial infarction within less than 6 months prior to signing the informed consent form; - moderate to severe heart failure (classes III and IV according to NYHA classification); - uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg) ; - a history of atopic asthma , angioedema; - respiratory failure (moderate to severe), grade 3 or 4 chronic obstructive pulmonary disease; - any other concomitant diseases (including, but not limited to, metabolic, hematological, renal, hepatic, pulmonary, neurological, endocrine, cardiac, infectious, gastrointestinal disorders), which expose the subject to an unacceptable risk during the study therapy; 12.

Known or suspected systemic autoimmune diseases (including, but not limited to, systemic lupus erythematosus, Crohn's disease, nonspecific ulcerative colitis, systemic scleroderma, inflammatory myopathy, mixed connective tissue disease, overlap syndrome, etc.) ; 13. History of interstitial pulmonary disease or pneumonitis requiring systemic glucocorticoids; 14. The need for glucocorticoid therapy (at >10 mg/day prednisolone equivalent doses) or any other drugs with immunosuppressive effects within 14 days prior to randomization; 15. Hematologic abnormalities :

- neutrophils <1.5×109/L; - platelets <100×109/L; - hemoglobin <90 g/L; 16.

Renal impairment: creatinine ≥2.5×ULN; 17. Hepatic impairment :

- total bilirubin ≥3×ULN (except for subjects with Gilbert's syndrome, in whom bilirubin levels should not exceed 50 μmol/L), - AP, AST or ALT ≥2.5×ULN (≥5×ULN in case of subjects with liver metastases); 18.

Any antitumor treatment within less than 4 weeks or surgery within less than 28 days prior to randomization within the study; 19. History of oncological disease, except for radically treated diseases with remission for over 5 years prior randomization in this study ; 20. Conditions limiting the subject's ability to comply with the Protocol requirements (in the Investigator's opinion ); 21. Participation in other clinical studies within less than 30 days prior to randomization and during this clinical study ; 22. Acute infections or activation of chronic infectious diseases or systemic antibacterial therapy within less than 28 days prior to randomization; 23. Active hepatitis B, active hepatitis C (confirmed by PCR), active syphilis, HIV-infection, currently or previously ; 24. Impossibility to administer the investigational product intravenously; 25. Impossibility to administer intravenous contrast agents (including due to hypersensitivity to contrast media); 26. Hypersensitivity to any of the components of BCD-100 or BCD-217; 27. A history of hypersensitivity to monoclonal antibody products; 28. Pregnancy or breastfeeding.

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.	NCT05732805
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, India, Russian Federation
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma, Melanoma (Skin), Melanoma Stage III, Melanoma Stage IV, Melanoma Unresectable, Melanoma Metastatic, Melanoma Advanced

Additional Details

This study is designed as a phase III, randomized, double-blind, placebo-controlled study. After the stratification procedure, subjects are randomized in a 1:1 ratio into 2 groups: - BCD-217 + placebo (4 doses) → prolgolimab (BCD-217 group) - Prolgolimab + placebo (4 doses) → prolgolimab (BCD-100 monotherapy group)

Arms & Interventions

Arms

Experimental: BCD-217 (nurulimab + prolgolimab)

BCD-217 followed by prolgolimab 1 mg/kg monotherapy.

Active Comparator: BCD-100 (prolgolimab)

Prolgolimab monotherapy.

Interventions

Biological: - BCD-217

Subject recieves BCD-217 0.2 mL/kg, which is equivalent to 1 mg/kg nurulimab + 3 mg/kg prolgolimab, as an intravenous infusion once every 3 weeks (Q3W) simultaneously with placebo, a total of 4 intravenous infusions. Beginning with the 5th infusion, subjects are switched to prolgolimab 1 mg/kg monotherapy once every 2 weeks (Q2W).

Biological: - BCD-100

Subject recieves prolgolimab 3 mg/kg as an intravenous infusion once every 3 weeks (Q3W) simultaneously with placebo, a total of 4 intravenous infusions. Beginning with the 5th infusion, subjects are switched to prolgolimab 1 mg/kg monotherapy once every 2 weeks (Q2W).

Biological: - Placebo

Placebo

Contact a Trial Team

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International Sites

Babruysk, Belarus

Status

Recruiting

Address

Healthcare Institution "Bobruisk Interdistrict Oncological Dispensary"

Babruysk, ,

Site Contact

Igor A Sharf

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