A Phase Ib/III Randomized, Multicenter, Global Study of Volrustomig Plus Casdatifan or Volrustomig Monotherapy Versus Nivolumab Plus Ipilimumab as First-line Treatment for Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 9
- 试验地点
- 3
- 主要终点
- Number of participants with adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
This is a Phase Ib/III, randomized, multicenter, global study evaluating the efficacy and safety of volrustomig in combination with casdatifan for the first-line (1L) treatment of participants with advanced clear cell renal cell carcinoma (ccRCC).
The Phase III part of the study will no longer be conducted.
详细描述
The primary purpose of this study is to measure the efficacy and safety of volrustomig in combination with casdatifan in participants with advanced ccRCC (as 1L treatment).
The study was planned to comprise of 2 parts - Phase Ib and Phase III.
In Phase 1b part of the study, participants are planned to be randomized in a 1:1 ratio to receive either dose 1 or dose 2 of volrustomig in combination with casdatifan.
The Phase III part of the study will no longer be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None (Outcomes Assessor)
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
- •Histologically or cytologically confirmed RCC with clear cell component.
- •Advanced/metastatic RCC or recurrent disease that has not previously been treated with systemic therapy in the 1L setting.
- •Karnofsky Performance Status ≥ 70%.
- •Provision of acceptable tumor sample.
- •At least one lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements.
排除标准
- •History of leptomeningeal disease or spinal cord compression.
- •Symptomatic brain metastases.
- •Medical history of severe chronic obstructive pulmonary disease.
- •Active or prior documented autoimmune or inflammatory disorders.
- •Prior systemic therapy for advanced/metastatic RCC. Note - Other inclusion and exclusion criteria may apply as stated in the protocol.
研究组 & 干预措施
Arm 1B (Volrustomig Dose 2 + Casdatifan)
Participants will receive dose 2 of volrustomig in combination with casdatifan.
干预措施: Casdatifan (Drug)
Arm 1A (Volrustomig Dose 1 + Casdatifan)
Participants will receive dose 1 of volrustomig in combination with casdatifan.
干预措施: Casdatifan (Drug)
Arm 1A (Volrustomig Dose 1 + Casdatifan)
Participants will receive dose 1 of volrustomig in combination with casdatifan.
干预措施: Volrustomig (Drug)
Arm 1B (Volrustomig Dose 2 + Casdatifan)
Participants will receive dose 2 of volrustomig in combination with casdatifan.
干预措施: Volrustomig (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
时间窗: Up to Day 90 (+7) post last dose
Number of participants who received at least one dose of study treatment will be assessed.
次要结局
未报告次要终点