Clinical trial BCD-263-2/UNIVERSE, A Double-Blind, Randomized Efficacy and Safety Clinical Trial of BCD-263 and Opdivo® Used as Monotherapy in Subjects with Advanced Cutaneous Melanoma.
The purpose of this clinical trial is to demonstrate comparable efficacy and similar safety and immunogenicity profiles of BCD-263 and Opdivo following repeated intravenous administration in subjects with advanced unresectable or metastatic cutaneous melanoma who:
Are 18 years of age or older;
Have documented diagnosis (histological conclusion) of unresectable (stage III) or metastatic (stage IV) melanoma;
This study has exclusion criteria (criteria for non-eligibility for participation in a specific clinical trial), the full list of which will be communicated to the potential participant by the Investigator. In particular, exclusion criteria are:
Eye or mucosal melanoma;
Active metastases in the CNS and/or carcinomatous meningitis.
Indications for radical (surgical, radiation) therapy.
Previous systemic antineoplastic therapy for advanced unresectable or metastatic cutaneous melanoma. Patients who have been treated with neoadjuvant or adjuvant therapy using targeted or immunotherapy drugs may be included, provided that:
such therapy was completed at least 6 months prior to randomization,
there has been no disease recurrence during such therapy and within 6 months after its completion.
BCD-263-2/UNIVERSEA Double-Blind, Randomized Efficacy and Safety Clinical Trial of BCD-263 and Opdivo® Used as Monotherapy in Subjects with Advanced Cutaneous Melanoma, is being performed at study centers in the Russian Federation and the Republic of Belarus cities, such as Moscow, St. Petersburg, Novosibirsk, Omsk, Barnaul, Chelyabinsk, Saransk, Nizhny Novgorod, Tomsk, Rostov-on-Don, Ufa, Ivanovo, Volgograd, Izhevsk, Minsk, Brest and Gomel, etc.
You can ask questions about participation in the clinical trial, including clarifying the study center contact information, using the “Do you have any questions?” form.
The Investigator will inform the potential participant about other eligibility criteria and contraindications for participation in this clinical trial. Potential participants should review the complete trial information and consult with the Investigator and/or the attending physician.
Clinical trial authorization by the Ministry of Health of the Russian Federation No. 137 dated April 10, 2024 was published in the State Register of Medicines.