A Study to Evaluate the Safety and Efficacy of Nivolumab With Ipilimumab in Participants With Untreated Advanced Kidney Cancer Conducted in India

Arms (1)

1. type

   EXPERIMENTAL

   label

   Nivolumab + ipilimumab

   interventionNames

   1. Biological: Nivolumab
   2. Biological: Ipilimumab

Primary outcomes (1)

1. measure

   Total Number of Participants Experiencing High Grade Immune-Mediated Adverse Events (IMAE)

   timeFrame

   From first dose until 100 days after the last dose or for a maximum of 52 weeks from the date of the first on-study dose of nivolumab, whichever occurs earlier.

   description

   IMAEs are a type of adverse event that occurs when the immune system reacts against the body's own tissues, including diarrhea/colitis, hepatitis, pneumonitis, nephritis and renal dysfunction, rash, and endocrine (adrenal insufficiency, hypophysitis, hypothyroidism/thyroiditis, hyperthyroidism, and diabetes mellitus). IMAE analyses includes events, regardless of causality, which occurred during the study and follow-up. Only participants who received immune-modulating medication for treatment of the event are reported, with the exception of endocrine events, which will be included regardless of treatment since these events are often managed without immunosuppression. High grade (Grade 3 to 4 and Grade 5) IMAEs are reported. IMAEs are graded on a scale from 1 to 5, in which Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events may require hospitalization; Grade 5 events are fatal.