A Phase 2, Open-label Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 5
- 主要终点
- Objective Response Rate (ORR) by RECIST v1.1 as Assessed by the Investigator
研究概览
简要总结
This is an open label Phase 2, 2-stage, 2-cohort study to evaluate rucaparib in combination with nivolumab in patients with high-grade serous or endometroid ovarian cancer.
Patients entering the following cohorts must have BRCA mutational status confirmed by a central lab:
- Cohort A1: No BRCA mutation in tumor; high level of LOH (loss of heterozygosity)
- Cohort A2: BRCA mutation in tumor
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
- •≥ 18 years of age
- •Adequate organ function
- •Life expectancy ≥ 16 weeks
- •Women of childbearing potential must have a negative serum pregnancy test
- •High-grade serous or endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer
- •Received 1 or 2 prior regimens, including ≥ 1 prior platinum-based therapy and have platinum-sensitive disease
- •Relapsed/progressive disease (confirmed by radiologic assessment)
- •Willing and able to have a biopsy of tumor at screening and after 4 weeks of treatment.
- •Measurable disease (RECIST v1.1)- Cohort A1 only
- •ECOG performance status of 0 to 1
- •General Exclusion Criteria
- •Active second malignancy
- •Central nervous system brain metastases
- •Evidence of interstitial lung disease, active pneumonitis, myocarditis, or history of myocarditis.
- •Active, known or suspected autoimmune disease (eg, autoimmune hepatitis).
- •Condition requiring systemic treatment with either corticosteroids
- •Prior treatment with a PARP inhibitor or immune checkpoint inhibitor.
- •Non-epithelial tumors (pure sarcomas) or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors. Mixed Mullerian tumors/carcinosarcomas are allowed.
排除标准
- 未提供
研究组 & 干预措施
Cohort A: Ovarian Cancer Cohort
Oral rucaparib and Intravenous (IV) nivolumab (combination therapy)
- Cohort A1
- Cohort A2
干预措施: Rucaparib (Drug)
Cohort A: Ovarian Cancer Cohort
Oral rucaparib and Intravenous (IV) nivolumab (combination therapy)
- Cohort A1
- Cohort A2
干预措施: Nivolumab (Drug)
结局指标
主要结局
Objective Response Rate (ORR) by RECIST v1.1 as Assessed by the Investigator
时间窗: From enrollment until disease progression (up to approximately 2 years)
Objective response rate (ORR) is defined as the percentage of patients with a best confirmed response of complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by the investigator.
The Effect of Rucaparib on the Immune Microenvironment
时间窗: From enrollment to primary completion of study (up to approximately 2 years)
Change in expression of the immune marker PD-L1 pre and post-rucaparib treatment; Cohort A2 only
次要结局
- ORR by RECIST v1.1 and Gynecological Cancer InterGroup (GCIG) Cancer Antigen 125 (CA-125 Criteria)(For patients with measurable disease, every 8 weeks after the start of combination treatment for 3 years, then every 24 weeks thereafter until disease progression or up to 25 months. Study data collection expected to last for 2 years.)
- Progression-free Survival (PFS)(From randomization until disease progression (up to approximately 2 years))
- Duration of Response (DOR)(For patients with measurable disease, every 12 weeks after the start of combination treatment for 3 years, then every 24 weeks thereafter until disease progression. Study data collection expected to last for 2 years)