A Phase II Study Evaluating the Efficacy and Safety of Weekly Paclitaxel or Nab-Paclitaxel Combined With Pembrolizumab and Mirabegron in Patients With Recurrent Ovarian Cancer
概览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Obstetrics & Gynecology Hospital of Fudan University
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
概览
简要总结
The goal of this clinical trial is to learn if drug regimen weekly paclitaxel/nab-paclitaxel, pembrolizumab, and mirabegron works to treat relapsed ovarian cancer in adults. It will also learn about the safety of the drug regimen. The main questions it aims to answer are:
i) Does drug weekly paclitaxel/nab-paclitaxel, pembrolizumab, and mirabegron reduce tumor volume? ii) What medical problems do participants have when taking drug weekly paclitaxel/nab-paclitaxel, pembrolizumab, and mirabegron?
Participants will:
i) Take drug paclitaxel/nab-paclitaxel every week and pembrolizumab every 21 days with everyday mirabegron ii) Visit the clinic once every 2 months for checkups and tests iii) Keep a diary of their symptoms
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
盲法说明
This is a single-arm, open-label, Phase II interventional study designed to evaluate the efficacy and safety of weekly paclitaxel or nab-paclitaxel in combination with pembrolizumab and mirabegron in patients with recurrent ovarian cancer. All eligible participants will receive the same treatment regimen without randomization or masking. The study aims to assess treatment response, safety profile, and preliminary clinical benefit in this target population.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Has provided documented informed consent for the study.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
- •Has received a front line platinum-based regimen (administered via either intravenous or intraperitoneal route) per local standard of care or treatment guideline following the primary or interval debulking surgery with documented disease recurrence (note: Maintenance treatment following the front line treatment is permitted and counted together as part of the front line treatment).
- •Has a platinum-free interval (PFI) of \< 12 months if the last regimen received is a platinum-based, or a treatment-free interval (TFI) of \< 12 months if the last regimen received is a non-platinum-based.
- •Has measurable disease at baseline based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.
- •Has a life expectancy of ≥12 weeks.
- •Has provided a tumor tissue sample either collected from prior cytoreductive surgery or fresh newly obtained tumor tissue at screening.
- •Has adequate organ function.
- •Has not recovered from AEs to ≤ Grade 1 or prior treatment level due to a previously administered agent.
排除标准
- •Has nonepithelial cancers, borderline tumors, mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma.
- •Has received prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated antigen-4 \[CTLA-4\], tumor necrosis factor receptors OX-40 or CD137).
- •Has received prior systemic anticancer therapy including radiation therapy or maintenance therapy within 4 weeks before enrollment.
- •Has severe hypersensitivity (≥Grade 3) or uncontrolled hypertension to paclitaxel/nab-paclitaxel, pembrolizumab, mirabegron and any of their excipients.
- •Has undergone major surgery within 3 weeks before enrollment or has complications/sequelae that have not yet recovered.
- •Has a known additional malignancy that progressed or required active treatment within the last 5 years.
- •Is pregnant or breastfeeding.
- •Has a history of allogenic tissue/solid organ transplant.
- •Has a history of thrombotic disorders, hemorrhage, hemoptysis, or active gastrointestinal bleeding within 6 months before enrollment.
- •Has a history of active autoimmune disease.
研究组 & 干预措施
Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron
Participants receive weekly paclitaxel/nab-paclitaxel plus pembrolizumab via intravenous (IV) infusion plus on Day 1 of each 21-day cycle orally with daily mirabegron until intolerance or disease progression.
干预措施: Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Month 6
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR). ORR was defined as the percentage of participants who had a Complete Response (Disappearance of all target lesions) or a Partial Response (≥30% decrease in the sum of the longest diameter of target lesions) using RECIST 1.1 based on BICR.
次要结局
- Progression Free Survival (PFS) at 6 Months(Month 6)
- Overall Survival (OS) at 6 Months(Month 6)
- Progression Free Survival (PFS) at 12 Months(Month 12)
- Overall Survival (OS) at 12 Months(Month 12)
- Incidence of grade 3-4 Adverse Events (AEs)(up to 1 month after the end of treatment)
研究者
Xin Wu
Director
Obstetrics & Gynecology Hospital of Fudan University