Trial results for the Phase 4 study (NCT04513522) evaluating nivolumab with ipilimumab in participants with untreated advanced kidney cancer were posted on ClinicalTrials.gov on 2025-07-11. The study, conducted in India, assessed the safety and efficacy of this combination regimen, detailing the incidence of high-grade immune-mediated adverse events.
Background
The study investigated the combination of nivolumab and ipilimumab for participants diagnosed with previously untreated advanced renal cell carcinoma (RCC) or metastatic RCC (mRCC). Renal cell carcinoma is a significant malignancy, and advanced or metastatic forms often present therapeutic challenges, making the evaluation of new treatment regimens crucial.
Trial design
The study (NCT04513522) was a Phase 4, interventional trial that enrolled 101 participants. It focused on individuals with Kidney Neoplasms, specifically intermediate and poor-risk participants with previously untreated advanced or metastatic renal cell carcinoma in India. The interventions studied were the combination of nivolumab and ipilimumab, administered to assess their safety and efficacy in this patient population.
Key results
The trial reported on the "Total Number of Participants Experiencing High Grade Immune-Mediated Adverse Events (IMAE)" for the Nivolumab + Ipilimumab treatment group. A total of 12 distinct measurements for high-grade immune-mediated adverse events were reported. For these specific event types, the individual counts of participants experiencing such events ranged from 0 to 2 participants. The reported counts for these measurements were 2, 1, 2, 1, 0, 0, 0, 0, 0, 0, 0, and 0 participants, indicating that a limited number of participants experienced high-grade IMAEs across the various categories assessed.
What this means
The results from this Phase 4 study provide important safety data for the combination of nivolumab and ipilimumab in untreated advanced kidney cancer patients in India. The observed low numbers of high-grade immune-mediated adverse events suggest that this regimen may have a manageable safety profile within this specific patient cohort. These findings contribute to the understanding of the safety landscape for this immunotherapy combination in a real-world setting, which is particularly valuable for guiding clinical decisions in regions like India where the study was conducted. While these safety results are encouraging, a comprehensive assessment would also consider efficacy outcomes, which were part of the study's purpose.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04513522, titled "A Study to Evaluate the Safety and Efficacy of Nivolumab With Ipilimumab in Participants With Untreated Advanced Kidney Cancer Conducted in India," were posted on 2025-07-11 on clinicaltrials.gov.