NCT04513522CompletedPhase 4
A Study to Evaluate the Safety and Efficacy of Nivolumab With Ipilimumab in Participants With Untreated Advanced Kidney Cancer Conducted in India
A Phase 4 Study of Nivolumab in Combination With Ipilimumab in Patients With Previously Untreated Advanced Renal Cell Carcinoma and Intermediate-or Poor-risk Factors Conducted in India
Source: ClinicalTrials.gov · Last updated 11 Jul 2025
Brief summary (registry, in English)
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 (RCC) or metastatic RCC (mRCC) in India.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 101 (actual)
- First submitted
- 13 Aug 2020
- Start date
- 17 Dec 2020
- Primary completion date
- 4 Jan 2024
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Kidney cancer
- NCT number
- NCT04513522
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 101
- From 17 Dec 2020 to the primary completion date, 4 Jan 2024
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- Participants with active, untreated, symptomatic central nervous system (CNS) metastases
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 0005 Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Local Institution - 0006 Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| Local Institution - 0017 Coordinator of this site? Confirm its status | Delhi | India | Unknown status |
| Local Institution - 0002 Coordinator of this site? Confirm its status | Karnataka | India | Unknown status |
| Local Institution - 0019 Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| Local Institution - 0013 Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| Local Institution - 0016 Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| Local Institution - 0001 Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| Local Institution - 0007 Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Local Institution - 0012 Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Local Institution - 0011 Coordinator of this site? Confirm its status | Trivandrum | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.