International Trial of the Efficacy and Safety of BCD-100 in Patients With Melanoma

Summary

An International Multicenter Open-label Randomized Trial of the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of BCD-100 (JSC BIOCAD, Russia) as Monotherapy in Patients with Unresectable/Metastatic Melanoma.

Timeline

Start

2017-08-31

Primary completion

2018-08-29

Completion

2021-01

Publications

• Demidov L, Kharkevich G, Petenko N, Moiseenko V, Protsenko S, Semiglazova T, Zimina A, Kovalenko N, Fadeeva N, Kirtbaya D, Belogortsev I, Tantsyrev D, Odintsova S, Nesterova A, Vorontsova K, Makarycheva Y, Linkova Y, Zinkina-Orikhan A, Siliutina A, Sorokina I, Liaptseva D, Chistyakov V, Lutsky A. A phase III study to access the safety and efficacy of prolgolimab 250 mg fixed dose administered every 3 weeks versus prolgolimab 1 mg/kg every 2 weeks in patients with metastatic melanoma (FLAT). Front Oncol. 2024 Sep 4;14:1385685. doi: 10.3389/fonc.2024.1385685. eCollection 2024.
• Tjulandin S, Demidov L, Moiseyenko V, Protsenko S, Semiglazova T, Odintsova S, Zukov R, Lazarev S, Makarova Y, Nechaeva M, Sakaeva D, Andreev A, Tarasova A, Fadeyeva N, Shustova M, Kuryshev I. Novel PD-1 inhibitor prolgolimab: expanding non-resectable/metastatic melanoma therapy choice. Eur J Cancer. 2021 May;149:222-232. doi: 10.1016/j.ejca.2021.02.030. Epub 2021 Apr 17.

Drugs

Indications