A Real-world Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (MIRV) in Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer With Expression of Folate Receptor α（FRα）
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 主要终点
- Incidence of Grade ≥ 3 Treatment-Related Adverse Events (TRAEs)
研究概览
简要总结
Mirvetuximab soravtansine (MIRV) is an antibody-drug conjugate approved for the treatment of ovarian cancer. However, real-world data on its safety and effectiveness in routine clinical practice are limited, especially in the Chinese patient population. MIRAS is a multicenter, prospective，observational, real-word study of MIRV in patients of advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer with expression of FRα.This study aims to evaluate the real-world safety and efficacy of MIRV in patients with advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer that expresses FRα. Data will be collected from medical records of patients who received MIRV as part of their routine clinical care.
详细描述
This prospective, multicenter, observational cohort study aims to evaluate the real-world safety and effectiveness of MIRV in patients with advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer with FRα expression.
Approximately 400 patients are planned to be enrolled from approximately 40 centers in China. On Day 1 of each 21-day cycle (every 3 weeks, Q3W), all patients will receive MIRV at a dose of 6 mg/kg based on adjusted ideal body weight (AIBW), either as monotherapy or in combination with other anticancer agents per clinical guideline recommendations. The starting dose may be adjusted by the investigator based on the patient's actual clinical condition. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, loss to follow-up, death, or other protocol-specified events requiring treatment discontinuation, whichever occurs first.
The screening period is up to 28 days. Safety assessments, including laboratory tests, eastern cooperative oncology group（ECOG）performance status, vital signs, physical examinations, ophthalmologic examinations, adverse events, and concomitant medications, will be conducted every 3 weeks (± 1 week) during treatment. Tumor imaging assessments by computed tomography(CT ) or magnetic resonance imaging（MRI）per response evaluation criteria in solid tumors v1.1（RECIST v1.1） will be performed every 2-3 cycles (± 7 days) to evaluate treatment response. Serum carbohydrate antigen 125（CA125）will be assessed within 14 days prior to the first dose, before each MIRV administration, and at each tumor imaging assessment (± 4 days).
For patients who permanently discontinue MIRV treatment, an end-of-treatment visit will be conducted within 7 days, followed by a safety follow-up visit 30 days (± 2 to +14 days) after the last dose. Survival follow-up will be conducted every 3 months (± 1 month) thereafter until death, loss to follow-up, withdrawal of survival follow-up consent, or end of study, whichever occurs first.
All data will be collected from routine clinical practice, entered into an electronic data capture (EDC) system, and analyzed using descriptive statistics. Time-to-event endpoints will be estimated using the Kaplan-Meier method. No additional interventions or study-mandated procedures are required beyond standard of care. This study is strictly observational and does not involve any investigational new drug application (IND) with the U.S. FDA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients who meet all of the following inclusion criteria are eligible to participate in the study:
- •Female patients aged ≥18 years.
- •Patients must have histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
- •Patients must have PD on or after the most recent anti-cancer therapy.
- •Patients must have FRα expression confirmed by VENTANA FOLR1 (≥ 25% of tumor cells with intensity ≥ 2 + after FRα staining).
- •Patients must have normal major organ function and be suitable for MIRV monotherapy or combination therapy according to clinical recommendations
- •Patients must have at least 1 evaluable lesion per RECIST v1.1 (radiologically assessed by the investigator).
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) score must be 0-
- •All toxicities (except alopecia) associated with prior therapy must have recovered to ≤ grade 1 per common terminology criteria for adverse events （CTCAE）v5.
- •Patients must have had completed any major surgery at least 4 weeks prior to the first dose of MIRV, and have recovered or stabilized from postoperative complications of prior surgery.
- •Patients must have expected survival of at least 12 weeks as assessed by the investigator.
- •Patients must sign informed consent form（ICF）, and willingness and ability to comply with the study protocol, including scheduled treatment, regular follow-up, and examinations.
排除标准
- •Patients who meet any of the following criteria may not be enrolled in the study:
- •Participation in other clinical studies during the same period.
- •Patient with known prior hypersensitivity to monoclonal antibody therapy or maytansinoids, or to study drug and/or any of its excipients.
- •Patients with active or chronic corneal disorders, history of corneal transplant, or active ocular conditions requiring ongoing treatment/monitoring such as uncontrolled glaucoma, wet age-related macular degeneration requiring treatment with intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema and/or monocular vision.
- •Patients with prior treatment with MIRV or other FRα-targeting agents. (Only for patients in prospective cohort)
- •Pregnant or breast-feeding females. Women of childbearing potential must agree to use highly effective contraception while using study drug and for at least 7 months after the last dose of MIRV.
- •Current participation in any interventional study other than routine clinical practice.
- •Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study
研究组 & 干预措施
All enrolled patients receiving MIRV-based therapy
This cohort includes all enrolled patients with FRα-expressing advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer who receive MIRV-based therapy in routine clinical practice. Patients may receive MIRV as monotherapy or in combination with other anticancer agents per physician's discretion and clinical practice guidelines.
干预措施: Mirvetuximab Soravtansine (MIRV) (Drug)
结局指标
主要结局
Incidence of Grade ≥ 3 Treatment-Related Adverse Events (TRAEs)
时间窗: From first dose to 30 days after last dose of MIRV
Incidence of Grade 3 or higher treatment-related adverse events (TRAEs) assessed by the investigator
Incidence of grade ≥ 3 treatment-related adverse events (TRAEs)
时间窗: From first dose to 30 days after last dose of MIRV
Incidence of grade 3 or higher treatment-related adverse events (TRAEs) assessed by the investigator
次要结局
- Investigator-assessed duration of response (DOR)(From first documented response to disease progression or death, up to approximately 24 months.)
- Overall survival (OS)(From first dose to death from any cause, up to approximately 36 months.)
- Incidence, severity and duration of treatment emergent adverse events (TEAEs) and TRAEs(From first dose to 30 days after last dose of MIRV.)
- Investigator-assessed objective response rate (ORR)(From first dose until disease progression, up to approximately 24 months)
- Investigator-assessed progression-free survival (PFS)(From first dose to disease progression or death, up to approximately 24 months.)
- CA125 response(From first dose until disease progression, assessed per GCIG criteria, up to approximately 24 months.)
研究者
NING LI-GYN
Professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences