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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

411

Participants

Timeline

Start Date

April 5, 2023

Primary Completion Date

January 31, 2027

Study Completion Date

June 30, 2027

Conditions
Melanoma Stage IIIMelanoma (Skin)
Interventions
BIOLOGICAL

BCD-217

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

BIOLOGICAL

anti-PD1

anti-PD1 agent in the adjuvant setting

PROCEDURE

Excision of the primary lesion

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

PROCEDURE

Regional lymphadenectomy

Regional lymphadenectomy will be performed per standard of care.

Trial Locations (36)

150054

Regional Clinical Oncology Hospital, Yaroslavl

156005

"Regional Goverment Budgetary Healthcare State Kostroma Oncology Center", Kostroma

190013

"JSC Modern Medical Technologies", Saint Petersburg

197758

Saint-Petersburg Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological), Saint Petersburg

220013

"Healthcare Institution Minsk City Clinical Cancer Center", Minsk

350040

Clinical Oncologic Dispensary No. 1, Krasnodar

354057

Clinical Oncologic Dispensary No. 2, Sochi

454087

"State Budgetary Healthcare Institution Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine,", Chelyabinsk

603006

"Nizhny Novgorod Region State Budgetary Healthcare Facility Clinical Diagnostics Center", Nizhny Novgorod

Unknown

"State Institution Republican Scientific and Practical Center of Oncology and Medical Radiology named after A.I. N.N. Alexandrov", Lesnoy

"State Institution Mogilev Regional Oncological Dispensary", Mogilev

"Healthcare Institution Vitebsk Regional Clinical Oncology Center", Vitebsk

State budgetary healthcare institution Leningrad Regional Clinical Hospital, Gatchina

"State Autonomous Health Institution Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigal", Kazan'

"State budgetary health care institution Kuzbass clinical oncological dispensary named after M.S. Rappoport", Kemerovo

"State Budgetary Institution of Healthcare Leningrad Regional Clinical Oncological Dispensary named after V.I. L.D. Romana", Kuz'molovskiy

"Russian Cancer Research Center named after N.N. Blokhin of the Ministry of Health of the Russian Federation", Moscow

Branch of Hadassah Medical LTD Limited Liability Company, Moscow

Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University), Moscow

"Joint Stock Company K31 City", Moscow

"JSC Medsi Group", Moscow

Moscow City Oncology Hospital No. 62, Moscow

"State budgetary health care institution of the city of Moscow City Clinical Oncology Hospital No. 1 of the Department of Health of the City of Moscow", Moscow

"LLC DobroMed", Novosibirsk

"State Budgetary Healthcare Institution Novosibirsk Regional Clinical Oncology Center of the Novosibirsk Region", Novosibirsk

"Federal State Budgetary Institution National Medical Research Center for Radiology of the Ministry of Health of the Russian Federation", Obninsk

"Budgetary healthcare institution of the Omsk region Clinical oncological dispensary", Omsk

City Hospital #40, Kurortny district, Saint Petersburg

"Federal State Budgetary Educational Institution of Higher Education Saint Petersburg State University", Saint Petersburg

"Limited Liability Company American Medical Clinic", Saint Petersburg

"Limited Liability Company Oncological Research Center", Saint Petersburg

"Limited Liability Company Strategic Medical Systems", Saint Petersburg

N.N. Petrov National Medicine Research Center of oncology, Saint Petersburg

Private Medical Institution Evromedservis, Saint Petersburg

"Federal State Educational Institution of Higher Professional Education Mordovia State University N.P. Ogareva ", Saransk

"State Health Care Institution Volgograd Regional Clinical Oncology Dispensary № 1", Volgograd

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biocad

INDUSTRY