A Randomized, Double-Blind Clinical Study of the Efficacy and Safety of BCD-201 (JSC BIOCAD) and Keytruda® in Patients With Unresectable or Metastatic Melanoma

BCD-201-2

This clinical study is designed as a randomized, double-blind trial. Subjects with unresectable, metastatic, or recurrent skin melanoma will be randomized to one of the two study groups (BCD-201 group and Keytruda group) at a 1:1 ratio. The goal of this study is to compare the efficacy and safety of BCD-201 and Keytruda as first-line therapy in subjects with unresectable, metastatic, or recurrent skin melanoma.

2022-07-18

2023-12-31

2024-12-31

Active (not recruiting)

Early phase I

366

Inclusion Criteria: * Signed informed consent; * Histologically confirmed melanoma; * Tumor first detected at the stage of advanced unresectable or metastatic disease, or disease progressing during or recurring after previous radical therapy; * ECOG score 0-1; * At least one measurable lesion according to RECIST 1.1; * Laboratory test results consistent with adequate functioning of systems and organs; * Willingness of men and women of childbearing potential to use highly effective contraceptive methods from the signing of the informed consent form, throughout the study and for 6 months after the administration of the last product dose. Exclusion Criteria: * Indications for radical therapy (surgery, radiation therapy); * Uveal, ocular or mucosal melanoma; * Active CNS metastases and/or carcinomatous meningitis; * Subjects with severe concomitant disorders, life-threatening acute complications of the primary disease; * Concomitant diseases and/or conditions that significantly increase the risk of 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 therapy with glucocorticoids or any other drugs with immunosuppressive effects within 14 days prior to randomization; * History of (non-infectious) pneumonitis requiring glucocorticoid therapy or pneumonitis at the time of screening; * Hypersensitivity or allergy to any of the pembrolizumab product components; * Pregnancy or breastfeeding, as well as intention to become pregnant or father a child during the study period.

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2023-09-21