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.