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All Drugs and Chemicals

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

Melanoma, Cutaneous Malignant

Antineoplastic Agents

Pembrolizumab

Subjects will receive 2 cycles of BCD-217 neoadjuvant therapy, followed by index lymph node removal.

Subjects with pathological complete (pCR) and near complete response (pnCR) (Group 1A): excision of the primary lesion (if not previously performed) without regional lymphadenectomy, followed by up to 12 months of anti-PD1 agent in the adjuvant setting.

Subjects will receive 2 cycles of BCD-217 neoadjuvant therapy, followed by index lymph node removal.

Subjects with a pathological partial response (pPR) or non-responders (pNR) to neoadjuvant therapy (Group 1B): excision of the primary lesion (if not performed earlier), regional lymphadenectomy, then up to 12 months of adjuvant therapy with anti-PD1 agent.

Subjects start treatment with excision of the primary lesion (if not previously performed), regional lymphadenectomy followed by adjuvant therapy with anti-PD1 agent (up to 12 months). This approach is considered the standard therapy for patients in the target population.

BCD-217 (anti-CTLA4 agent nurulimab + anti-PD1) once every 3 weeks in the neoadjuvant setting

anti-PD1

Excision of the primary lesion will be performed per standard of care.

Excision of the primary lesion

Regional lymphadenectomy will be performed per standard of care.

Regional lymphadenectomy

Julia M Makarova, MD

Dmitry V Kirtbaya, MD

Nikolay V Kislov, MD, PhD

Natalya V Fadeeva, PhD in Medicine

Anastasiia V Zimina

Vladimir M Moiseenko, MD, PhD

Timur T Andabecov

This study is an open-label, randomized, comparative phase III study, which will include subjects with resectable stage III skin melanoma (up to 3 resectable transient metastases are acceptable).

In both study groups, adjuvant therapy is possible until melanoma progresses to unresectable stage III-IV, unacceptable toxicity, withdrawal of ICF or the end of the therapy period (12 months).

In case of postoperative relapse of the disease, at the decision of the investigator and if the lesion is resectable, radical surgical treatment can be carried out (R0 - resection) in accordance with current clinical guidelines without withdrawing the patient from the study.

A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma

A Randomized Study of the Efficacy and Safety of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) Versus Standard Adjuvant Therapy With Pembrolizumab in Patients With Resectable Stage III Skin Melanoma.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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 Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma	NCT05751928	Melanoma Stage ... Melanoma (Skin)	BCD-217 anti-PD1 Excision of the... Regional lympha...	18 Years -	Biocad
A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma	NCT05751928	Melanoma Stage ... Melanoma (Skin)	BCD-217 anti-PD1 Excision of the... Regional lympha...	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

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