A Phase 1 Study to Compare Bempegaldesleukin Combined With Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI Alone in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (mRCC) (PIVOT IO 011)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 37
- 主要终点
- Incidence of changes in clinical laboratory results by severity: Hematology tests (Part 1)
研究概览
简要总结
The purpose of this study is in Part 1, to determine the safety of nivolumab, bempegaldesleukin (BEMPEG: NKTR-214), and Tyrosine Kinase Inhibitor (TKI) combination.
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
- •Histological confirmation of renal cell carcinoma (RCC) with clear cell component including participants who may also have sarcomatoid features
- •Advanced (not amenable to curative surgery or radiation therapy) or metastatic (American Joint Committee on Cancer (AJCC) Stage 4) RCC
- •No prior systemic therapy, including prior PD-L1 therapy, for RCC is allowed with the following exception:
- •i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC is allowed. Therapy must have included an agent that targets vascular endothelial growth factor (VEGF) pathway or VEGF receptors and recurrence must have occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy
- •Life Expectancy ≥ 12 weeks
- •Karnofsky Performance Status (KPS) of at least 70%
- •Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria
- •Males and females must agree to follow specific methods of contraception, if applicable
排除标准
- •Active CNS brain metastases or leptomeningeal metastases
- •Active, known or suspected autoimmune disease
- •Inadequately treated adrenal insufficiency
- •History of pulmonary embolism (PE), deep vein thrombosis (DVT), or prior clinically significant venous or non-CVA/TIA arterial thromboembolic event (eg, internal jugular vein thrombosis) within 3 months prior to treatment assignment (Part 1) and randomization (Part 2)
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Part 1A (Part 1): Nivolumab + Axitinib
干预措施: Nivolumab (Biological)
Part 1A (Part 1): Nivolumab + Axitinib
干预措施: Axitinib (Drug)
Part 1B (Part 1): Nivolumab + Cabozantinib
干预措施: Nivolumab (Biological)
Part 1B (Part 1): Nivolumab + Cabozantinib
干预措施: Cabozantinib (Drug)
结局指标
主要结局
Incidence of changes in clinical laboratory results by severity: Hematology tests (Part 1)
时间窗: Up to 2.5 years
Incidence of serious adverse events (SAEs) (Part 1)
时间窗: Up to 2.5 years
Incidence of AEs leading to discontinuation (Part 1)
时间窗: Up to 5 years
Incidence of adverse events (AEs) by severity (Part 1)
时间窗: Up to 2.5 years
Incidence of changes in clinical laboratory results by severity: Clinical Chemistry tests (Part 1)
时间窗: Up to 2.5 years
Incidence of dose-limiting toxicities (DLTs) (Part 1)
时间窗: Up to 2.5 years
Incidence of immune-mediated adverse events (imAEs) (Part 1)
时间窗: Up to 5 years
Incidence of changes in clinical laboratory results by severity: Urinalysis tests (Part 1)
时间窗: Up to 2.5 years
次要结局
未报告次要终点