A Phase 3, Open-label, Multicenter, Randomized Study of BG-C9074 With Bevacizumab Versus Bevacizumab as First-line Maintenance Therapy for Patients With Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After First-line Platinum-based Chemotherapy Plus Bevacizumab (Starstone-Ovarian 301/GOG-3144/ENGOT-ov108/APGOT-OV29)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 主要终点
- Progression-Free survival (PFS) assessed by Blinded Independent Central Review (BICR)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of BG-C9074 with bevacizumab (Arm A) versus bevacizumab monotherapy (Arm B) in adults with epithelial ovarian, fallopian tube, or primary peritoneal cancers who have not progressed after firstline platinum-based chemotherapy plus bevacizumab.
详细描述
Ovarian cancer is a disease where abnormal cells in the ovaries or fallopian tubes grow out of control and form tumors. Common early signs include belly bloating, pelvic or back pain, feeling full quickly when eating, and frequent urination.
BG-C9074 is a targeted cancer medicine called an antibody-drug conjugate (ADC). ADC consists of an antibody linked to a drug that can kill cancer cells. The antibody part of BG-C9074 specifically attaches to a protein called B7-H4 that is found on the surface of cancer cells. After it attaches to B7-H4, BG-C9074 enters the cancer cell where the drug causes DNA damage and cell death. Bevacizumab is an approved medicine used to treat these cancers along with chemotherapy. It works by cutting off the blood supply that helps the tumor grow, which may help keep the cancer under better control.
The purpose of this study is to test if BG-C9074 is safe and effective in women with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer when it is given in combination with bevacizumab as a first-line maintenance treatment.
This study has 2 treatment groups. Participants will be randomly assigned (by chance, like flipping a coin) to receive one of the treatments listed below:
- Arm A: BG-C9074 + Bevacizumab
- Arm B: Bevacizumab
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
- 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
- •Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤
- •Participants must have a histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma (serous, endometrioid, or clear cell).
- •Participants are newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) stage III or IV and have received primary debulking surgery or interval debulking surgery.
- •Participants must have adequate organ function.
- •Women of childbearing potential must be willing to use a highly effective method of birth control and agree not to donate eggs (ova, oocytes) or freeze/store eggs for the duration of the study and for ≥ 7 months after the last dose of study treatment.
排除标准
- •Participants have ovarian, fallopian tube, or peritoneal cancer of nonepithelial origin.
- •Participants have either a germline or somatic BReast CAncer gene (BRCA) mutation as per local test.
- •Participants who will receive poly-adenosine diphosphate ribose polymerase (PARP) inhibitor as maintenance therapy per standard of care and investigator discretion.
- •Participants have a history of allergic reactions or hypersensitivity to the active ingredients and excipients of the drug products and other monoclonal antibodies.
- •Participants had previous transient ischemic attack, cerebrovascular accident, or subarachnoid hemorrhage within 6 months prior to randomization
- •Participants have evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy).
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Arm A: BG-C9074 + Bevacizumab
BG-C9074 will be administered first, followed by bevacizumab.
干预措施: Bevacizumab (Drug)
Arm A: BG-C9074 + Bevacizumab
BG-C9074 will be administered first, followed by bevacizumab.
干预措施: BG-C9074 (Drug)
Arm B: Bevacizumab
Bevacizumab will be administered alone.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Progression-Free survival (PFS) assessed by Blinded Independent Central Review (BICR)
时间窗: Up to 5 years
PFS is defined as the time from randomization to the date of disease progression by BICR based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death, whichever occurs first.
次要结局
- Overall Survival (OS)(Up to 5 years)
- PFS, as Assessed by Investigator(Up to 5 years)
- PFS2, as Assessed by Investigator(Up to 5 years)
- Time to Next Treatment(Up to 5 years)
- Number of Participants with Treatment-Emergent Adverse Events, Treatment-Related Adverse Events, and Serious Adverse Events(From first dose of study drug up to 30 days after last dose, up to 24 months)
- Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) - F17 Global Health Status/Quality of Life (GHS/QoL), Role Functioning, and Physical Functioning Domain Scores(Baseline and up to approximately 2 years)
- Change from Baseline in EORTC QLQ -Ovarian Cancer Module (OV28) Abdominal/GI Symptoms Domain Score(Baseline and up to approximately 2 years)
- Time to Deterioration (TTD) of GHS/QoL, Role Functioning, and Physical Functioning Domain Scores as Measured via EORTC QLQ - F17(Up to 5 years)
- Time to deterioration (TTD) of Abdominal/GI Symptoms as Measured via EORTC QLQ - OV28(Up to 5 years)