NCT04230954终止2 期
A Phase II Study of Cabozantinib (XL184) Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
Drug: Cabozantinib Drug: Pembrolizumab
详细描述
This study is a multi-center, single arm, open label trial to evaluate the efficacy and safety of Cabozantinib (XL184) plus Pembrolizumab in recurrent, persistent and/or metastatic cervical cancer with PD-L1 tumor positivity.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Recurrent or persistent cervical cancer after prior systemic chemotherapy for which there is no curative intent option
- •Documented histologic cervical cancer (acceptable histologies: squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma)
- •Patients must have PD-L1 tumor positivity as defined as CPS>/= 1
- •Age greater than 18 and ECOG performance status of <= 2
- •Adequate organ and marrow function
排除标准
- •Prior treatment with cabozantinib or pembrolizumab
- •Receipt of any type of small molecule kinase inhibitor
- •Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy
- •Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment
- •Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery
- •Anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel)
- •Uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: Cardiovascular disorders: Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias Uncontrolled hypertension despite optimal antihypertensive treatment, stroke
- •Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation
- •Clinically significant hematuria, hematemesis, or hemoptysis of > 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before first dose
- •Active autoimmune disease requiring systemic therapy within the past 2 years
- •Active infection requiring systemic therapy within the past month
- •History of immunodeficiency
研究组 & 干预措施
Cabozantinib (XL 184) Plus Pembrolizumab
Experimental
A Phase II Study of Cabozantinib (XL 184)Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer
干预措施: Cabozantinib 40 MG oral once a day (Drug)
Cabozantinib (XL 184) Plus Pembrolizumab
Experimental
A Phase II Study of Cabozantinib (XL 184)Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer
干预措施: Pembrolizumab 200 mg IV every 3 weeks (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: Up to 24 months
Six months progression free survival as defined by RECIST v1.1 measured from signed written consent to the date of first documented tumor progression using RECIST v1.1, or death due to any cause or 24 months after the end of study treatment.
次要结局
- Overall Response Rate(Up to 24 months)
- Cervical Cancer Quality of Life(Up to 6 Months)
- Overall Survival(Up to 24 months)
- Incidence of Emergent Adverse Events(Up to 6 Months)
研究者
研究点 (1)
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