A Study to Evaluate the Safety and Efficacy of Nivolumab With Ipilimumab in Participants With Untreated Advanced Kidney Cancer Conducted in India
NCT ID: NCT04513522
Last Updated: 2025-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
101 participants
INTERVENTIONAL
2020-12-17
2024-01-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nivolumab + ipilimumab
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Interventions
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Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Qualifies as intermediate or poor risk by meeting at least one of the prognostic factors as per the International Metastatic RCC Database Consortium (IMDC) criteria
* Indian participants with Indian ethnicity living in India
* No prior systemic therapy for RCC
* Measurable disease lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Exclusion Criteria
* Major surgery less than 28 days prior to the first dose of study treatment
* Participants with an autoimmune disease, or any other condition, requiring systemic treatment with either corticosteroids or other immunosuppressive medications
18 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0005
Ahmedabad, Gujarat, India
Local Institution - 0011
Trivandrum, Kerala, India
Local Institution - 0013
Mumbai, Maharashtra, India
Local Institution - 0001
Mumbai, Maharashtra, India
Local Institution - 0007
New Delhi, National Capital Territory of Delhi, India
Local Institution - 0006
Bangalore, , India
Local Institution - 0017
Delhi, , India
Local Institution - 0002
Karnataka, , India
Local Institution - 0019
Kolkata, , India
Local Institution - 0016
Mumbai, , India
Local Institution - 0012
Pune, , India
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA209-7C9
Identifier Type: -
Identifier Source: org_study_id
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