Clinical study BCD-263-1 «A double-blind, randomized clinical study of the pharmacokinetics and safety of BCD-263 and Opdivo® as monotherapy in subjects with advanced melanoma of the skin».
The aim of this clinical study is to compare the pharmacokinetics, pharmacodynamics, safety and immunogenicity of BCD-263 and Opdivo® after single and multiple intravenous doses in subjects who:
Are aged 18 years or older
Have a body weight of 60 to 90 kg
Have a documented diagnosis (histological evidence) of unresectable (stage III) or metastatic (stage IV) melanoma
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:
Ocular or mucosal melanoma
Active metastases in the brain, or brain lesions measuring more than 1.5 cm
The BCD-263-1 study, "A double-blind, randomized clinical study of the pharmacokinetics and safety of BCD-263 and Opdivo® as monotherapy in subjects with advanced melanoma of the skin," takes place in study centers of different cities in the Russian Federation: Moscow, Saint Petersburg, Novosibirsk, Omsk, Barnaul, Chelyabinsk, Saransk, Kostroma, Sochi, Nizhny Novgorod, Pyatigorsk, Tomsk, Kaliningrad, Severodvinsk, Arkhangelsk, Kazan, Ufa.
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?».
The study doctor will tell the potential participant about other eligibility criteria and contraindications for participation in this clinical study. The potential participant should read the full information about the study and consult the study doctor and/or attending physician.