The BCD-217-2/OCTAVA clinical study will assess the main safety and efficacy parameters of BCD-217 after administration of BCD-217 and subsequent administration of Forteсa® in comparison with Forteca® alone in patients with unresectable or metastatic melanoma who:
Are diagnosed with untreated unresectable stage III melanoma or untreated metastatic (stage IV) melanoma based on histological examination of the tumor tissue.
Have had the tumor tissue examined and/or provided their consent to a biopsy.
Have provided their consent to the evaluation of the PD-L1 status and BRAF V600 mutation status at a central laboratory.
Have a life expectancy of not less than 12 weeks, as estimated by the total tumor burden.
Have 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 radiotherapy, surgery for the underlying disease at screening.
Previous use of any systemic anticancer drugs for unresectable or metastatic melanoma.1
Previous use of checkpoint inhibitors (e.g., anti-CTLA-4 and/or anti-PD-1/PD-L1/PD-L2 drugs).
Previous use of BRAF and MEK protein kinase inhibitors.
Ocular melanoma.
Mucosal melanoma.
CNS metastases.
Impossibility to determine the PD-L1 status and/or BRAF status.
Radiotherapy, chemotherapy, immunotherapy 4 weeks or less before the expected administration of BCD-217.
Surgical treatment 28 days or less before the expected administration of BCD-217.
Other concomitant diseases or conditions that may affect the safety of BCD-217 or preclude any of the necessary study procedures.
This study will be conducted in study centers of different cities in Russia and the Republic of Belarus: Moscow, Saint Petersburg, Novosibirsk, Omsk, Barnaul, Chelyabinsk, Saransk, Kostroma, Yaroslavl, Arkhangelsk, Sochi, Nizhny Novgorod, Pyatigorsk, Minsk, Brest, and Vitebsk.
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.
Authorization of the Ministry of Health of the Russian Federation for this clinical study, No. 438 dated July 07, 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. 49/1221/2022 dated September 14, 2022, and the list of approved study centers have been published in the State Register of Clinical Studies of the Republic of Belarus.
Patients who have received neoadjuvant and adjuvant treatment for early melanoma that was completed at least 6 weeks before enrollment in the BCD-217-2/OCTAVA study can participate in this study.