JPRN-jRCT2031210397进行中（未招募）2 期
Phase II study of pembrolizumab and bevacizumab in combination with platinum-based chemotherapy followed by pembrolizumab, bevacizumab and olaparib in patients with platinum-sensitive recurrent ovarian cancer
Hasegawa Kosei0 个研究点目标入组 26 人开始时间: 2021年10月29日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •1. Participant is at least 20 years of age on the day of signing informed consent with histologically confirmed epithelial ovarian cancer (excluding borderline ovarian tumor) excluding mucinous carcinoma.
- •2. Participant has received one or two regimen of PBC (3 cycles or more) as prior therapy with clinical CR or PR after the last PBC.
- •3. Participant has documentation of progressive disease at least 6 months from completion of last PBC (platinum-sensitive).
- •4. Participant with measurable disease based on RECIST 1.1 at screening
- •5. Participant is able to provide a core or excisional biopsy of a tumor for testing of PD-L1 status, etc.
- •6. Participant with Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1 at the screening
- •7. Participant has a life expectancy of at least 12 weeks as determined by the investigators.
- •8. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- •a. Not a woman of childbearing potential (WOCBP), or
- •b. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 210 days after the last dose of study treatment.
- •9. Participant has provided written informed consent for the study (legally acceptable representative is acceptable if applicable).
- •10. Participant has adequate organ function.
排除标准
- •1. A WOCBP who has a positive urine pregnancy test at screening. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •2. Participant has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
- •3. Participant has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to the first dose of study drug.
- •4. Participant has received prior radiotherapy within 2 weeks of the first dose of study drug.
- •5. Participant has received major surgery within 4 weeks prior to the first dose of study drug.
- •6. Participant has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
- •7. Participant is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study drug.
- •8. Participant has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- •9. Participant has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- •10. Participant has known active CNS metastases and/or carcinomatous meningitis.
- •11. Participant has severe hypersensitivity ( >=Grade 3) to the study treatment and/or any of its excipients.
- •12. Participant has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
- •13. Participant has a history of (non-infectious) pneumonitis/interstitial lung disease that required treatment with steroids or has current pneumonitis/interstitial lung disease.
- •14. Participant has an active infection requiring systemic therapy.
- •15. Participant has a known history of Human Immunodeficiency Virus (HIV) infection.
- •16. 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.
- •17. Participant has received colony-stimulating factors (granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 2 weeks prior to the first dose of study drug.
- •18. Participant has clinically serious cardiovascular/cerebrovascular diseases (eg, cerebrovascular accident/stroke [less than 6 month prior to enrollment], myocardial infarction [less than 6 month prior to enrollment], uncontrolled and potentially reversible cardiac conditions [unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >500 msec, electrolyte disturbances, hypertension defined as systolic >150 mmHg or diastolic >90 mmHg etc.] or participant has congenital long QT syndrome).
- •19. Participant has known abdominal fistula, gastrointestinal fistula or gastrointestinal perforation and/or higher risks of bleeding.
- •20. Participant has either myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML.
- •21. Participant is currently receiving either strong (eg, itraconazole
研究者
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