Phase 3b/4 Safety Trial of Nivolumab Combined With Ipilimumab in Subjects With Previously Untreated, Advanced or Metastatic RCC (CheckMate 920: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 920)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 211
- 试验地点
- 59
- 主要终点
- Number of Participants With High Grade (Grade 3-4) Immune Mediated Adverse Events (IMAEs)
研究概览
简要总结
To investigate the safety of Nivolumab in combination with Ipilimumab in subjects with previously untreated advanced or metastatic Renal Cell Cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Type of Participant and Target Disease Characteristics
- •Advanced or metastatic RCC
- •Histologically confirmed, previously untreated (treatment-naive) RCC
- •No prior systemic therapy for RCC except for one prior adjuvant or neoadjuvant therapy for completely resectable RCC
- •Measurable disease as per RECIST 1.
- •Subject must have extracranial metastasis as measurable disease
- •Karnofsky Performance Status (KPS) of at least 70% for Cohort 1, 2, and 3; KPS of 50-60% for Cohort 4
- •Tumor tissue need be received by the central vendor (block or unstained slides). Note: Fine Needle Aspiration (FNA)and bone metastases samples are not acceptable for submission.
排除标准
- •Medical Conditions
- •Subjects with any active autoimmune disease or a history of known autoimmune disease
- •Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
- •Known HIV or AIDS-related illness
- •Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection.
- •Prior/Concomitant Therapy
- •Prior systemic treatment in the metastatic setting with Vascular epithelial growth factor(VEGF) or VEGF receptor targeted therapy
- •Prior treatment with an anti-Programmed Death (PD) -1, anti-PD-L1, anti-PD-L2, anti-cluster of differentiation 137 (CD137), or anti-cytotoxic T-lymphocyte-associated antigen 4(CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. This includes the utilization of these agents in the neo-adjuvant or adjuvant setting.
- •Anti-cancer therapy less than 28 days prior to the first dose of study drug or palliative, focal radiation therapy less than 14 days prior to the first dose of study drug.
- •Other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
ccRCC KPS ≥ 70%
Clear-Cell Renal Cell Carcinoma (ccRCC) with Karnofsky Performance Status (KPS) ≥ 70%
干预措施: Ipilimumab (Drug)
ccRCC KPS ≥ 70%
Clear-Cell Renal Cell Carcinoma (ccRCC) with Karnofsky Performance Status (KPS) ≥ 70%
干预措施: Nivolumab (Drug)
Non-ccRCC, KPS ≥ 70%
Non Clear-Cell Renal Cell Carcinoma (nccRCC) with KPS ≥ 70%
干预措施: Nivolumab (Drug)
Non-ccRCC, KPS ≥ 70%
Non Clear-Cell Renal Cell Carcinoma (nccRCC) with KPS ≥ 70%
干预措施: Ipilimumab (Drug)
RCC with non-active Brain Mets, KPS ≥70%
Renal Cell Carcinoma (RCC) with non-active Brain Metastases, with KPS ≥70%
干预措施: Nivolumab (Drug)
RCC with non-active Brain Mets, KPS ≥70%
Renal Cell Carcinoma (RCC) with non-active Brain Metastases, with KPS ≥70%
干预措施: Ipilimumab (Drug)
any RCC with KPS 50%-60%
Renal Cell Carcinoma (RCC), regardless of any histology or existing non-active brain metastasis, with KPS 50%-60%
干预措施: Nivolumab (Drug)
any RCC with KPS 50%-60%
Renal Cell Carcinoma (RCC), regardless of any histology or existing non-active brain metastasis, with KPS 50%-60%
干预措施: Ipilimumab (Drug)
结局指标
主要结局
Number of Participants With High Grade (Grade 3-4) Immune Mediated Adverse Events (IMAEs)
时间窗: Approximately 39 Months
Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity
Number of Participants With High Grade (Grade 5) Immune Mediated Adverse Events (IMAEs)
时间窗: Approximately 39 Months
Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity
次要结局
- Number of Participants Who Received Hormone Replacement Therapy for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)(From first dose up to 100 days post last dose (up to approximately 29 months))
- Time to Response Rate (TRR)(From the date of first dose to first documented CR or PR, up to approximately 15 months)
- Median Progression Free Survival (PFS)(From first dose to the date of the first documented progressive disease, up to approximately 12 months)
- Number of Participants Who Received Immune Modulating Medication for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)(From first dose up to 100 days post last dose (up to approximately 29 months))
- Time to Onset of Grade 3-5 Immune Mediated Adverse Events (IMAEs)(From first dose to the earliest IMAE (grade 3-5) event onset date (up to approximately 116 weeks))
- Time to Resolution of Grade 3-5 Immune Mediated Adverse Events (IMAEs)(From the IMAE onset date to the IMAE end date, up to approximately 194 weeks)
- Number of Participants Who Received ≥ 40mg of Prednisone for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)(From first dose up to 100 days post last dose (up to approximately 29 months))
- Objective Response Rate (ORR)(From first dose up to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (up to approximately 26 months))
- Duration of Response (DOR)(From first confirmed response to the date of the first documented tumor progression or death, up to approximately 48 months)