Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Rare Diseases

Death

Melanoma

Melanoma, Cutaneous Malignant

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Immunomodulating Agents

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

BCD-217

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

Fedor B Kriukov, MD PhD

Anna A Siliutina, MD PhD

Nikolaii B Ermakov

Svetlana A Demidova

Natalia I Ivanova

Aleksei L Obukhov

Julia M Makarova, MD

Dmitry V Kirtbaya, MD

Nikolay V Kislov, MD, PhD

Natalya V Fadeeva, PhD in Medicine

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

Irina S Shumskaya

Artem A Zeidlits

Vadim V Kozlov

Natalia A Falaleeva

Anastasiia V Zimina

Svetlana V Odintsova, MD

Vladimir M Moiseenko, MD, PhD

Julia V Semiletova

Andrei V Kutkovich

Timur T Andabecov

Ivan S Sardaryan

Artem N Poltoratski

Konstantin D Pen'kov

Pavel Skopin, PhD

Dmitrii V Gladishev

Nadezhda V Kovalenko, MD

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.

Biocad

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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

Spots Global Cancer Trial Database for excision of the primary lesion