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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 11
- 主要终点
- Total Number of Participants Experiencing High Grade Immune-Mediated Adverse Events (IMAE)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Nivolumab + ipilimumab
干预措施: Nivolumab (Biological)
Nivolumab + ipilimumab
干预措施: Ipilimumab (Biological)
结局指标
主要结局
Total Number of Participants Experiencing High Grade Immune-Mediated Adverse Events (IMAE)
时间窗: 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.
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.
次要结局
- Time to Onset of High Grade Immune-Mediated Adverse Event (IMAE)(From first dose until onset of IMAE (up to approximately 15 months))
- Time to Resolution of High Grade Immune-Mediated Adverse Event (IMAE)(From first dose until resolution of IMAE (up to approximately 15 months))
- The Number of Participants Who Received Immune-Modulating Medication(From first dose up to 100 days after last dose (up to approximately 15 months))
- Objective Response Rate (ORR)(From first dose up to 100 days after last dose (up to approximately 15 months))
- Duration of Response (DoR)(From first documented response (CR or PR) up to first documented progression or death due to any cause, whichever occurs first (up to approximately 3 years))
- Time to Response (TTR)(From first dose to the date of CR or PR (up to approximately 15 months))