Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of Nivolumab With Ipilimumab in Participants With Untreated Advanced Kidney Cancer Conducted in India
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Kidney Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the safety and efficacy of nivolumab combined with ipilimumab in intermediate and poor-risk participants with previously untreated advanced renal cell carcinoma ...
Eligibility Criteria
Inclusion
- Histological confirmation of renal cell carcinoma (RCC) with clear cell component including participants who may have sarcomatoid features
- 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
- Participants with active, untreated, symptomatic central nervous system (CNS) metastases
- 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
- Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
December 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2024
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04513522
Start Date
December 17 2020
End Date
January 4 2024
Last Update
July 11 2025
Active Locations (11)
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1
Local Institution - 0005
Ahmedabad, Gujarat, India, 380054
2
Local Institution - 0011
Trivandrum, Kerala, India, 695011
3
Local Institution - 0013
Mumbai, Maharashtra, India, 400 057
4
Local Institution - 0001
Mumbai, Maharashtra, India, 400012