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Immunomodulating Agents

BCD-217 followed by prolgolimab 1 mg/kg monotherapy.

Subject recieves BCD-217 0.2 mL/kg, which is equivalent to 1 mg/kg nurulimab + 3 mg/kg prolgolimab, as an intravenous infusion once every 3 weeks (Q3W) simultaneously with placebo, a total of 4 intravenous infusions. Beginning with the 5th infusion, subjects are switched to prolgolimab 1 mg/kg monotherapy once every 2 weeks (Q2W).

BCD-217

Subject recieves prolgolimab 3 mg/kg as an intravenous infusion once every 3 weeks (Q3W) simultaneously with placebo, a total of 4 intravenous infusions. Beginning with the 5th infusion, subjects are switched to prolgolimab 1 mg/kg monotherapy once every 2 weeks (Q2W).

BCD-100

Placebo

Anna A Siliutina, MD PhD

Fedor B Kriukov, MD PhD

Igor A Sharf

Vitalii S Volkov

Vasilii N Belyakovskii

Dmitrii P Norik

Nikolaii B Ermakov

Svetlana A Demidova

Natalia I Ivanova

Aleksei L Obukhov

Amit Bhargava, MD

M S Athiyamaan, MD

Prabhat G Bhargava, MD

Ajay O Mehta, MD

Rajnish Nagarkar, MD

Bhushan Nemade, MD

Sameer Rastogi, MD

Chetanavata Deshmukh, MD

Rakesh Neve, MD

Vaibhav Amale, MD

Kaushal Patel, MD

Anshul Agrawal, MD

Natalya V Fadeeva, MD, PhD

Victoria V Chistyakova

Yana S Chapko, MD

Sergei A Kolomiets

Oleg A Gladkov

Olga V Kurchenkova

Mariia V Smagina

Sufia Z Safina, MD

Artur Z Azanov

Vera A Vaschenko

Igor O Belogortsev

Leo Demidov

Igor A Utiashev

Elena V Poddubskaya

Elena F Satirova

Anastasiia S Mochalova

Daniil L Stroyakovsky, MD, PhD

Marina A Lyadova

Mikhail Yu Fedyanin

Irina S Shumskaya

Artem A Zeidlits

Vadim V Kozlov

Natalia A Falaleeva

Anastasiya V Zimina

Svetlana A Protsenko

Svetlana V Odintsova, MD

Julia V Semiletova

Ivan V Rikov

Sergei V Orlov

Timur T Agishev

Andrei V Kutkovich

Ivan S Sardaryan

Timur T Andabekov, PhD in Medicine

Artem N Poltoratski

Konstantin D Pen'kov

Mikhail V Kopp

Vladimir Moiseenko, MD

Pavel Skopin, PhD

DmitriI V Kirtbaya

Dmitrii V Gladishev

Nadezhda V Kovalenko, MD

Nikolay V Kislov

The aim of study is to investigate the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of BCD-217 followed by prolgolimab monotherapy versus prolgolimab monotherapy as first-line therapy in subjects with unresectable or metastatic melanoma.

This study is designed as a phase III, randomized, double-blind, placebo-controlled study.

After the stratification procedure, subjects are randomized in a 1:1 ratio into 2 groups:

* BCD-217 + placebo (4 doses) → prolgolimab (BCD-217 group)
* Prolgolimab + placebo (4 doses) → prolgolimab (BCD-100 monotherapy group)

A Clinical Study of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma

A Double-Blind Placebo-Controlled Comparative Randomized Clinical Study of the Efficacy and Safety of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma

Biocad

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Clinical Study of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma	NCT05732805	Melanoma Melanoma (Skin) Melanoma Stage ... Melanoma Stage ... Melanoma Unrese... Melanoma Metast... Melanoma Advanc...	BCD-217 BCD-100 Placebo	18 Years -	Biocad
A Clinical Study of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma	NCT05732805	Melanoma Melanoma (Skin) Melanoma Stage ... Melanoma Stage ... Melanoma Unrese... Melanoma Metast... Melanoma Advanc...	BCD-217 BCD-100 Placebo	18 Years -	Biocad

Spots Global Cancer Trial Database for melanoma unresectable