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Активно (без набиране) Фаза 3 NCT03141177

A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Фаза 3 – широко изпитване преди одобрение
Заболявания: Renal Cell Carcinoma

Спонсор: Bristol-Myers Squibb

Налично на: БГ
Обобщение
The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal cell carcinoma
Кой може да участва
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid features * Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC * No prior systemic therapy for RCC with the following exception: i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy Exclusion Criteria: * Any active CNS metastases * Any active, known or suspected autoimmune disease * Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization * Participants who have received a live/attenuated vaccine within 30 days of first treatment Other protocol defined inclusion/exclusion criteria could apply
Места на провеждане 18
Argentina (1)
Local Institution - 0046
CABA , Buenos Aires
Австралия (1)
Local Institution - 0002
North Ryde , New South Wales
Бразилия (1)
Local Institution - 0057
Belo Horizonte , Minas Gerais
Chile (1)
Local Institution - 0045
Santiago , Santiago Metropolitan
Чехия (1)
Local Institution - 0034
Hradec Králové
Германия (1)
Local Institution - 0013
Aachen
Гърция (1)
Local Institution - 0082
Athens
Израел (1)
Local Institution - 0072
Haifa
Италия (1)
Local Institution - 0054
Arezzo
Япония (1)
Local Institution - 0148
Akita , Akita
Mexico (1)
Local Institution - 0108
Zapopan , Jalisco
Полша (1)
Local Institution - 0084
Biała Podlaska
Румъния (1)
Local Institution - 0021
Cluj-Napoca
Russia (1)
Local Institution - 0020
Moscow
Испания (1)
Local Institution - 0125
Barcelona
Турция (1)
Local Institution - 0107
Ankara
Великобритания (1)
Local Institution - 0111
London
САЩ (1)
Local Institution - 0077
Daphne , Alabama
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
23.07.2017
Крайна дата
16.01.2026
Регистрационен номер
NCT03141177
Източник
anzctr
Запитване за медицински туризъм

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