Clinical Study of the Efficacy and Safety of BCD-201 and Keytruda in Subjects With Advanced Melanoma

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.