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Active (not recruiting) Phase 3 NCT03141177

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

Phase 3 – large-scale trial before approval
Conditions: Renal Cell Carcinoma

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
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
Who can participate
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
Locations 18
Argentina (1)
Local Institution - 0046
CABA , Buenos Aires
Australia (1)
Local Institution - 0002
North Ryde , New South Wales
Brazil (1)
Local Institution - 0057
Belo Horizonte , Minas Gerais
Chile (1)
Local Institution - 0045
Santiago , Santiago Metropolitan
Czech Republic (1)
Local Institution - 0034
Hradec Králové
Germany (1)
Local Institution - 0013
Aachen
Greece (1)
Local Institution - 0082
Athens
Israel (1)
Local Institution - 0072
Haifa
Italy (1)
Local Institution - 0054
Arezzo
Japan (1)
Local Institution - 0148
Akita , Akita
Mexico (1)
Local Institution - 0108
Zapopan , Jalisco
Poland (1)
Local Institution - 0084
Biała Podlaska
Romania (1)
Local Institution - 0021
Cluj-Napoca
Russia (1)
Local Institution - 0020
Moscow
Spain (1)
Local Institution - 0125
Barcelona
Turkey (1)
Local Institution - 0107
Ankara
United Kingdom (1)
Local Institution - 0111
London
United States (1)
Local Institution - 0077
Daphne , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
23.07.2017
Completion date
16.01.2026
Registry ID
NCT03141177
Source
anzctr
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