Spots Global Cancer Trial Database for A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma
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Trial Identification
Brief Title: A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma
Official Title: 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 ID: NCT05751928
Study Description
Brief Summary: 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).
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
State Institution "Republican Scientific and Practical Center of Oncology and Medical Radiology named after A.I. N.N. Alexandrov", Lesnoy, , Belarus
Healthcare Institution "Minsk City Clinical Cancer Center", Minsk, , Belarus
State Institution "Mogilev Regional Oncological Dispensary", Mogilev, , Belarus
Healthcare Institution "Vitebsk Regional Clinical Oncology Center", Vitebsk, , Belarus
Clinical Oncologic Dispensary No. 1, Krasnodar, Krasnodar Kari, Russian Federation
Clinical Oncologic Dispensary No. 2, Sochi, Krasnodar Territory, Russian Federation
Regional Clinical Oncology Hospital, Yaroslavl, Yaroslavskaya Oblast, Russian Federation
State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine",, Chelyabinsk, , Russian Federation
State budgetary healthcare institution Leningrad Regional Clinical Hospital, Gatchina, , Russian Federation
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, , Russian Federation
State budgetary health care institution "Kuzbass clinical oncological dispensary named after M.S. Rappoport", Kemerovo, , Russian Federation
Regional Goverment Budgetary Healthcare State "Kostroma Oncology Center", Kostroma, , Russian Federation
State Budgetary Institution of Healthcare "Leningrad Regional Clinical Oncological Dispensary named after V.I. L.D. Romana", Kuz'molovskiy, , Russian Federation
"Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation, Moscow, , Russian Federation
Branch of Hadassah Medical LTD Limited Liability Company, Moscow, , Russian Federation
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, , Russian Federation
Joint Stock Company "K31 City", Moscow, , Russian Federation
JSC "Medsi Group", Moscow, , Russian Federation
Moscow City Oncology Hospital No. 62, Moscow, , Russian Federation
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, , Russian Federation
Nizhny Novgorod Region State Budgetary Healthcare Facility "Clinical Diagnostics Center", Nizhny Novgorod, , Russian Federation
LLC "DobroMed", Novosibirsk, , Russian Federation
State Budgetary Healthcare Institution "Novosibirsk Regional Clinical Oncology Center" of the Novosibirsk Region, Novosibirsk, , Russian Federation
Federal State Budgetary Institution "National Medical Research Center for Radiology" of the Ministry of Health of the Russian Federation, Obninsk, , Russian Federation
Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary", Omsk, , Russian Federation
JSC "Modern Medical Technologies", Saint Petersburg, , Russian Federation
Saint-Petersburg Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological), Saint Petersburg, , Russian Federation
Federal State Budgetary Educational Institution of Higher Education "Saint Petersburg State University", Saint Petersburg, , Russian Federation
Limited Liability Company "American Medical Clinic", Saint Petersburg, , Russian Federation
Limited Liability Company "Oncological Research Center", Saint Petersburg, , Russian Federation
Limited Liability Company "Strategic Medical Systems", Saint Petersburg, , Russian Federation
N.N. Petrov National Medicine Research Center of oncology, Saint Petersburg, , Russian Federation
Private Medical Institution Evromedservis, Saint Petersburg, , Russian Federation
Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva ", Saransk, , Russian Federation
City Hospital #40, Kurortny district, St. Petersburg, , Russian Federation
State Health Care Institution "Volgograd Regional Clinical Oncology Dispensary № 1", Volgograd, , Russian Federation
Contact Details
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