Phase 4
Completed N=101
A Study to Evaluate the Safety and Efficacy of Nivolumab With Ipilimumab in Participants With Untreated Advanced Kidney Cancer Conducted in India
Source: ClinicalTrials.gov NCT04513522 ↗Enrolled (actual)
101
Serious AEs
36.6%
Results posted
Jul 2025
Primary outcomePrimary: Total Number of Participants Experiencing High Grade Immune-Mediated Adverse Events (IMAE) — 2; 1; 2; 1 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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 (RCC) or metastatic RCC (mRCC) in India.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Participants Experiencing High Grade Immune-Mediated Adverse Events (IMAE) |
2; 1; 2; 1; 0; 0 | — |
| SECONDARY Time to Onset of High Grade Immune-Mediated Adverse Event (IMAE) |
9.9; 7.29; 20.00; 29.21 | — |
| SECONDARY Time to Resolution of High Grade Immune-Mediated Adverse Event (IMAE) |
1.1; 10.07 | — |
| SECONDARY The Number of Participants Who Received Immune-Modulating Medication |
38 | — |
| SECONDARY Objective Response Rate (ORR) |
37.6 | — |
| SECONDARY Time to Response (TTR) |
2.79 | — |
| SECONDARY Duration of Response (DoR) |
NA | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04513522). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.