NCT04361370Enrolling By Invitation2 期
A Single-arm Phase II Study of Olaparib Maintenance With Pembrolizumab & Bevacizumab in BRCA Non-mutated Patients With Platinum-sensitive Recurrent Ovarian Cancer (OPEB-01)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- progression-free survival(6 months PFS rate)
研究概览
简要总结
This study is phase II, open label, clinical trial to determine the efficacy of Olaparib maintenance with Bevacizumab and Pembrolizumab by assessment progression-free survival(6 months PFS rate) in BRCA non-mutated patients with platinum-sensitive recurrent ovarian cancer.
详细描述
'This is a Phase II, open-label, non-randomized, multi-center study assessing the efficacy and safety of Olaparib maintenance with Bevacizumab and Pembrolizumab in subjects with platinum-sensitive who have received prior of platinum-based chemotherapy. The study will assess the effectiveness of progression-free survival(6 months PFS rate) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The subject will be treated to until disease progression as below:
- Maintenance : Olaparib 300mg (twice daily [BID])
- Pembrolizumab 200mg every 3 weeks (Q3W) from 2nd infusion for up to 35 infusions
- Bevacizumab 15mg/kg or 7.5mg/kg every 3 weeks (Q3W)
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant has histologically confirmed diagnosis of high-grade predominantly serous, endometrioid, carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC, primary peritoneal cancer, or fallopian tube cancer will be enrolled in this study (only up to 8 patients with clear cell carcinoma will be included and mucinous carcinoma will not be included).
- •Participant has received 2 previous courses of platinum-containing therapy, and has disease that was considered platinum sensitive following the penultimate (next to last) platinum course (more than 6 months' period between penultimate platinum regimen and progression of disease
- •Participant has responded to last the platinum regimen (complete or partial response), remains in response and is enrolled on study within 8 weeks of completion of the last platinum regimen
- •Participant is able to provide a newly obtained core or excisional biopsy of a tumor lesion for prospective testing of BRCA 1/2 and PD-L1 status prior to enrollment
- •Female participants who are at least 20 years of age and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Participant has adequate organ function as defined in the following:
- •ANC≥1500/µL
- •PLT≥100 000/µL
- •Hemoglobin≥9.0 g/dL or ≥5.6 mmol/L
- •Creatinine≤1.5 × ULN or calculated creatinine clearance≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN
- •Total bilirubin≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN
- •AST (SGOT) and ALT (SGPT)≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
- •International normalized ratio (INR) OR prothrombin time (PT), Activated partial thromboplastin time (aPTT)≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
排除标准
- •Participant has mucinous, germ cell, or borderline tumor of the ovary
- •Participant has a known or suspected deleterious mutation (germline or somatic) in either BRCA1 or BRCA2
- •Participant has a history of non-infectious pneumonitis that required treatment with steroids or currently has pneumonitis
- •Participant either has myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) or has features suggestive of MDS/AML
- •Participant has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- •Participant has known active CNS metastases and/or carcinomatous meningitis
- •Participant has a known history of active TB (Bacillus Tuberculosis)
- •Participant has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection
- •Participant has uncontrolled hypertension, defined as systolic > 140 mmHg or diastolic > 90 mmHg documented by 2 blood pressure readings taken at least 1 hour apart
- •Participant has a history of hemorrhage, hemoptysis or active gastrointestinal bleeding within 6 months prior to randomization
研究组 & 干预措施
Treatment group
Experimental
BRCA mutation wild type, non-mucinous , platinum-sensitive recurrent ovarian cancer
干预措施: Olaparib-Pembrolizumab-Bevacizumab (Drug)
结局指标
主要结局
progression-free survival(6 months PFS rate)
时间窗: 6 months
To determine the clinical effectiveness of the study treatment assessed using progression free survival(6months) according to RECIST v1.1 criteria (Investigator determined)
次要结局
- Overall survival (OS)(Up to 1year)
- Time to first subsequent treatment(or death)(The date of first documented first subsequent treatment or date of death, assessed up to 72 months)
- Time to second subsequent treatment(The date of first documented second subsequent treatment assessed up to 72 months)
- Time to tumour progression (TTP)(Up to 1year)
- progression-free survival(Up to 1year)
研究者
研究点 (1)
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