The BCD-201-2 clinical study will compare the efficacy and safety of BCD-201 and Keytruda® as first-line therapy in subjects with unresectable, metastatic or recurrent skin melanoma who:
Have a documented diagnosis of unresectable or metastatic melanoma.
Are aged 18 years or older.
Have not received systemic anticancer therapy for unresectable or metastatic disease.
Are in a satisfactory overall condition (ECOG score 0-1).
This study has exclusion criteria (precluding participation in this clinical study), which will all be explained to the potential participant by the study doctor. In particular, exclusion criteria include:
Indications for radical therapy (surgery, radiotherapy).
Uveal or mucosal melanoma.
Previous systemic anticancer therapy for advanced unresectable, recurrent or metastatic skin melanoma (a history of neoadjuvant or adjuvant therapy is allowed, provided that the therapy was completed at least 6 weeks before randomization).
Active CNS metastases and/or carcinomatous meningitis.
The need for treatment with glucocorticoids and any other drugs with immunosuppressive effects within 14 days before randomization.
A history of pneumonitis (non-infectious) requiring glucocorticoid therapy or existing pneumonitis at screening.
Any antitumor therapy or major surgery less than 28 days prior to randomization.
Concomitant use of drugs or medical devices studied in other clinical studies or their use within 30 days prior to randomization.
Other concomitant diseases or conditions that may affect the safety of BCD-201 or preclude any of the necessary study procedures.
This study will be conducted at study centers of different cities in the Russian Federation and the Republic of Belarus: Moscow, Saint Petersburg, Novosibirsk, Brest, Vitebsk, Minsk, and others.
You can ask questions about participation in the clinical study and request contact information about study centers using a special form «Do you have any questions?».
If necessary, transportation services may be provided upon agreement with the study doctor and upon the consent of the clinical study participant for trips related to the participation in this study. The study doctor will explain in detail the procedure for ordering transportation services to the participant of the clinical study.
Authorization of the Ministry of Health of the Russian Federation for this clinical study, No. 433 dated July 05, 2022, and the list of approved study centers have been published in the State Register of Medicines.
Authorization of the Ministry of Health of the Republic of Belarus for this clinical study, No. 50/1305/2022 dated September 28, 2022, and the list of approved study centers have been published in the State Register of Clinical Studies of the Republic of Belarus.