jRCT2080224597已完成3 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
pharmaand GmbH/ CMIC Co., Ltd.1 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study, parallel assignment
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- Female
入选标准
- •Have newly diagnosed, advanced (FIGO stage III-IV),high-grade 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.
- •Have sufficient tumor tissue for planned analyses.
- •Have an ECOG performance status of 0 to 1.
排除标准
- •1.Pure sarcomas or borderline tumors or mucinous tumors.
- •2.Active second malignancy
- •3.Known central nervous system brain metastases.
- •4.Any prior treatment for ovarian cancer, other than the first-line platinum regimen,
- •5.Evidence of interstitial lung disease, active pneumonitis,
- •6.Active, known or suspected autoimmune disease
- •7.Condition requiring active systemic treatment with either corticosteroids (more than 10 mg daily prednisone equivalent) or other immunosuppressive medications
结局指标
主要结局
-
efficacy Investigator assessed Progression-free survival (PFS)
次要结局
- PFS by RECIST
- Objective response rate (ORR) and Duration of response (DOR)
- Number of participants with treatment-emergent Adverse events (AEs)
- Number of participants with serious AEs
- Number of participants with laboratory abnormalities
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
European Randomised Trial of Ovarian Cancer Screening IICancerISRCTN79217590Cancer Research UK (CRUK) (UK)
终止
不适用
Improving communication about treatment options for asymptomatic ovarian cancer patients with rising cancer antigen 125 (CA-125): A randomised controlled trial of a Decision AidCommunication about treatment options and decision making for women with asymptomatic ovarian cancer and rising CA-125 levels.Cancer - Ovarian and primary peritonealACTRN12609001035213Centre for Medical Psychology and Evidence-based Decision-making178
已完成
不适用
orth Thames CA125 study in advanced ovarian cancerOvarian cancerCancerISRCTN75843298K Co-ordinating Committee for Cancer Research (UKCCCR)237
已完成
3 期
Phase III Randomized Trial of Maintenance Pegylated Liposomal Doxorubicin (PLD)/ Carboplatin versus without in Patients with Advanced Ovarian CancerAdvanced ovarian cancerCancer - Ovarian and primary peritonealACTRN12607000329460Chang Gung Memorial Hospital122
进行中（未招募）
1 期
A study to test efficacy of Rucaparib in patients with Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal CancerRelapsed, BRCA-Mutant, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal CancerMedDRA version: 20.0Level: PTClassification code 10038977Term: Retroperitoneal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10061328Term: Ovarian epithelial cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10016180Term: Fallopian tube cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-000816-14-PLClovis Oncology, Inc.345