A Real-world Study of Mirvetuximab Soravtansine (MIRV) in Ovarian Cancer Patients of Expression of Folate Receptor α（FRα） (MIRAS)
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）
研究概览
详细说明
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.
研究类型
注册 (估计的)
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
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 0-2.
- All toxicities (except alopecia) associated with prior therapy must have recovered to ≤ grade 1 per common terminology criteria for adverse events （CTCAE）v5.0.
- 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.
Exclusion Criteria:
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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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.
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The recommended dose of MIRV is 6 mg/kg based on adjusted ideal body weight (AIBW), administered intravenously on Day 1 of each 21-day cycle.
Investigators may adjust the starting dose based on the patient's actual clinical condition.
Premedication including antipyretics, antihistamines, corticosteroids, and antiemetics is administered prior to each infusion to reduce infusion-related reactions and gastrointestinal adverse events.
Prophylactic corticosteroid eye drops and artificial tears are used to manage ocular toxicity.
Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Dose reductions (to 5 mg/kg or 4 mg/kg AIBW) are permitted for management of adverse events per protocol-specified criteria.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of grade ≥ 3 treatment-related adverse events (TRAEs)
大体时间：From first dose to 30 days after last dose of MIRV
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Incidence of grade 3 or higher treatment-related adverse events (TRAEs) assessed by the investigator
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From first dose to 30 days after last dose of MIRV
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Investigator-assessed duration of response (DOR)
大体时间：From first documented response to disease progression or death, up to approximately 24 months.
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DOR defined as the time from first documented CR or PR (whichever occurs first) to disease progression according to RECIST v1.1 or death, whichever occurs first, assessed by investigators.
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From first documented response to disease progression or death, up to approximately 24 months.
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Overall survival (OS)
大体时间：From first dose to death from any cause, up to approximately 36 months.
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OS defined as the time from the first dose to death due to any cause (for patients who have been lost to follow-up prior to death, the time of last follow-up is usually used as the time of death).
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From first dose to death from any cause, up to approximately 36 months.
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Incidence, severity and duration of treatment emergent adverse events (TEAEs) and TRAEs
大体时间：From first dose to 30 days after last dose of MIRV.
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Incidence, severity, duration, and dose modifications of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) assessed by investigators per CTCAE v5.0.
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From first dose to 30 days after last dose of MIRV.
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Investigator-assessed objective response rate (ORR)
大体时间：From first dose until disease progression, up to approximately 24 months
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objective response rate defined as the proportion of patients with confirmed complete response (CR) or partial response (PR) per RECIST v1.1, assessed by investigators, with responses confirmed at least 4 weeks after initial response
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From first dose until disease progression, up to approximately 24 months
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Investigator-assessed progression-free survival (PFS)
大体时间：From first dose to disease progression or death, up to approximately 24 months.
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PFS defined as the time from the first dose to the first documented disease progression（PD）or death due to any cause, whichever occurs first, during the tumor assessment follow-up visit.
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From first dose to disease progression or death, up to approximately 24 months.
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CA125 response
大体时间：From first dose until disease progression, assessed per GCIG criteria, up to approximately 24 months.
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CA125 response defined as a change in serum CA125 levels according to Gynecologic Cancer Intergroup (GCIG) criteria.
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From first dose until disease progression, assessed per GCIG criteria, up to approximately 24 months.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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MIRV Treatment Patterns
大体时间：Baseline and throughout treatment period.
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Treatment patterns including patient characteristics at baseline, combination therapy regimens, and starting dose distribution.
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Baseline and throughout treatment period.
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Progression-Free Survival 2 (PFS2) and Subsequent Therapy
大体时间：From first dose to progression on subsequent therapy or death, up to approximately 36 months.
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Subsequent therapy after progression on MIRV and progression-free survival 2 (PFS2), defined as the time from first dose to progression on subsequent therapy or death.
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From first dose to progression on subsequent therapy or death, up to approximately 36 months.
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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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