2023-509711-83-00招募中3 期
A Phase 3, Randomized, Open-Label Study of Nivolumab Combined with Cabozantinib versus Sunitinib in Participants with Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 265
- 试验地点
- 23
- 主要终点
- Progression Free Survival (PFS) per blinded independent central review (BICR) of Arm A versus Arm C in all randomized participants
研究概览
简要总结
The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in the treatment of Kidney cancer in patients with previously untreated, advanced, or cancer that has spread
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid features
- •Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
- •No prior systemic therapy for RCC with the following exception: i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy
排除标准
- •Any active CNS metastases
- •Any active, known or suspected autoimmune disease
- •Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
结局指标
主要结局
Progression Free Survival (PFS) per blinded independent central review (BICR) of Arm A versus Arm C in all randomized participants
Progression Free Survival (PFS) per blinded independent central review (BICR) of Arm A versus Arm C in all randomized participants
次要结局
- Overall Survival (OS) of Arm A versus Arm C
- Objective Response Rate (ORR)
- Incidence of adverse events (AEs)
- Incidence of Serious Adverse Events (SAEs)
研究者
GSM-CT
Scientific
Bristol Myers Squibb International Corporation
研究点 (23)
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