EUCTR2017-004557-17-CZ进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy - ATHENA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Newly diagnosed advanced (FIGO stage III-IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer
- •Completed cytoreductive surgery, including at least a bilateral salpingo-oophorectomy and partial omentectomy, either prior to chemotherapy (primary surgery) or following neoadjuvant chemotherapy (interval debulking)
- •Completed first-line platinum-based chemotherapy and surgery with a response, in the opinion of the Investigator
- •Sufficient tumor tissue for planned analysis
- •ECOG performance status of 0 or 1
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 650
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 350
排除标准
- •Pure sarcomas or borderline tumors or mucinous tumors
- •Active second malignancy
- •Known central nervous system brain metastases
- •Any prior treatment for ovarian cancer, other than the first-line platinum regimen
- •Evidence of interstitial lung disease, active pneumonitis, myocarditis or a history of myocarditis
- •Active, known or suspected autoimmune disease (e.g. autoimmune hepatitis)
- •Condition requiring active systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications
研究者
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