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

Sponsor
Bristol-Myers Squibb
Study ID
NCT04513522
Phase
PHASE4
Status
Completed

Conditions

  • Kidney Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Ipilimumab — BIOLOGICAL
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
Dec 17, 2020
Status verified
Jul 2025
Primary completion
Jan 4, 2024
Completion
Jan 4, 2024

Study Design

Enrollment
101 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab + ipilimumab

Primary Outcome Measure

Total Number of Participants Experiencing High Grade Immune-Mediated Adverse Events (IMAE) [ Time Frame: 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. ]

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