ATHENA (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)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,097
- 试验地点
- 237
- 主要终点
- Monotherapy Arm B and Arm D: Investigator Assessed Progression-free Survival (PFS)
研究概览
简要总结
This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-Blind; only the safety cohort will be open label.
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
- •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
- •Patients must be 20 years of age to consent in Japan, Taiwan and South Korea; in all other participating countries patients must be 18 years of age to consent
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 or active pneumonitis
- •Active, known or suspected autoimmune disease
- •Condition requiring active systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications
研究组 & 干预措施
Japanese Open-label Safety Cohort
Oral rucaparib + IV nivolumab
干预措施: Nivolumab (Drug)
Arm A
Oral rucaparib + intravenous (IV) nivolumab
干预措施: Rucaparib (Drug)
Arm A
Oral rucaparib + intravenous (IV) nivolumab
干预措施: Nivolumab (Drug)
Arm B
Oral rucaparib + IV placebo
干预措施: Rucaparib (Drug)
Arm B
Oral rucaparib + IV placebo
干预措施: Placebo IV Infusion (Drug)
Arm C
Oral placebo + IV nivolumab
干预措施: Nivolumab (Drug)
Arm C
Oral placebo + IV nivolumab
干预措施: Placebo Oral Tablet (Drug)
Arm D
Oral placebo + IV placebo
干预措施: Placebo Oral Tablet (Drug)
Arm D
Oral placebo + IV placebo
干预措施: Placebo IV Infusion (Drug)
Japanese Open-label Safety Cohort
Oral rucaparib + IV nivolumab
干预措施: Rucaparib (Drug)
结局指标
主要结局
Monotherapy Arm B and Arm D: Investigator Assessed Progression-free Survival (PFS)
时间窗: From randomization until disease progression (up to the primary data analysis at approximately 39 months)
PFS by investigator was defined as the time from randomization to disease progression, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
Monotherapy Arm B and Arm D: Investigator Assessed PFS
时间窗: From randomization until disease progression (up to the primary data analysis at approximately 39 months)
PFS by investigator was defined as the time from randomization to disease progression, according to RECIST v1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
Combination Therapy Arm A and Arm B: Investigator Assessed PFS
时间窗: From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months)
PFS by investigator was defined as the time from randomization to disease progression, according to RECIST v1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
次要结局
- Monotherapy Arm B and Arm D: Blinded Independent Central Review (BICR) PFS(From randomization until disease progression (up to the primary data analysis at approximately 39 months))
- Monotherapy Arm B and Arm D: BICR PFS(From randomization until disease progression (up to the primary data analysis at approximately 39 months))
- Combination Therapy Arm A and Arm B: BICR PFS(From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months))
- Monotherapy Arm B and Arm D: Overall Survival (OS)(From randomization until death due to any cause (up to the primary data analysis at approximately 36 months))
- Monotherapy Arm B and Arm D: OS(From randomization until death due to any cause (up to the primary data analysis at approximately 40 months))
- Combination Therapy Arm A and Arm B: OS(From randomization until death due to any cause (up to the combination therapy interim analysis at approximately 72 months))
- Monotherapy Arm B and Arm D: Objective Response Rate (ORR)(From randomization until disease progression (up to the primary data analysis at approximately 39 months))
- Monotherapy Arm B and Arm D: ORR(From randomization until disease progression (up to the primary data analysis at approximately 39 months))
- Combination Therapy Arm A and Arm B: ORR(From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months))
- Monotherapy Arm B and Arm D: Duration of Response (DOR)(From first confirmed response until disease progression (up to the primary data analysis at approximately 30 months))
- Monotherapy Arm B and Arm D: DOR(From first confirmed response until disease progression (up to the primary data analysis at approximately 33 months))
- Combination Therapy Arm A and Arm B: DOR(From first confirmed response until disease progression (up to the combination therapy interim analysis at approximately 60 months))