EUCTR2019-003509-80-PL进行中（未招募）1 期
MIRASOL: A Randomized, Open-label, Phase 3 Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor-Alpha Expression
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 430
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Female patients = 18 years of age
- •2. Patients must have a confirmed diagnosis of high-grade serous EOC,
- •primary peritoneal cancer, or fallopian tube cancer
- •3. Patients must have platinum-resistant disease
- •a. Patients who have only had 1 line of platinum based therapy must have received at least 4 cycles of platinum, must have had a response
- •(CR or PR) and then progressed between > 3 months and = 6 months after the date last dose of platinum
- •b. Patients who have received 2 or 3 lines of platinum therapy must have
- •progressed on or within 6 months after the date of the last dose of
- •platinum Note: Progression should be calculated from the date of the last administered
- •dose of platinum therapy to the date of the radiographic imaging
- •showing progression.; Patients who are platinum-refractory during
- •front-line treatment are excluded (see exclusion criteria)
- •4. Patients must have progressed radiographically on or after their most recent line of
- •Note: Progression must be determined radiographically and/or by CA-125 GCIG progression criteria
- •5. Patients must be willing to provide an archival tumor tissue block or
- •slides, or undergo procedure to obtain a new biopsy using a low risk,
- •medically routine procedure for immunohistochemistry (IHC)
- •confirmation of FRa positivity
- •6. Patient's tumor must be positive for FRa expression as defined by the
- •Ventana FOLR1 (FOLR-2.1) CDx assay
- •7. Patients must have at least one lesion that meets the definition of
- •measurable disease by RECIST v1.1 (radiologically measured by the
- •Investigator)
- •8. Patients must have received at least 1 but no more than 3 prior
- •systemic lines of anticancer therapy, and for whom single-agent therapy
- •is appropriate as the next line of treatment:
- •a. Adjuvant ± neoadjuvant considered one line of therapy
- •b. Maintenance therapy (eg, bevacizumab, PARP inhibitors) will be
- •considered as part of the preceding line of therapy (ie, not counted
- •independently)
- •c. Therapy changed due to toxicity in the absence of progression will be
- •considered as part of the same line (ie, not counted independently)
- •d. Hormonal therapy will be counted as a separate line of therapy unless
- •it was given as maintenance.
- •9. Patient must have an Eastern Cooperative Oncology Group
- •Performance Status (ECOG PS) of 0 or 1
- •10. Time from prior therapy:
- •a. Systemic antineoplastic therapy (5 half-lives or 4 weeks, whichever is
- •b. Focal radiation completed at least 2 weeks prior to first dose of study
- •11. Patients must have stabilized or recovered (Grade 1 or baseline)
- •from all prior therapy-related toxicities
- •12. Major surgery must be completed at least 4 weeks prior to first dose
- •and have recovered or stabilized from the side effects of prior surgery
- •13. Patients must have adequate hematologic, liver and kidney functions
- •defined as:
- •a. Absolute neutrophil count (ANC) = 1.5 x 109/L (1,500/µL) without G
- •CSF in the prior 10 days or long-acting WBC growth factors in the prior 20 days
- •b. Platelet count = 100 x 109/L (100,000/µL) without platelet
- •transfusion in the prior 10 days
- •c. Hemoglobin = 9.0 g/dL without packed red blood cell (PRBC) transfusion in the prior 21 days
- 另有 6 项未显示
排除标准
- •1. Patients with endometrioid, clear cell, mucinous, or sarcomatous
- •histology, mixed tumors containing any of the above histologies, or lowgrade
- •or borderline ovarian tumor
- •2. Patients with primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first
- •line platinum-containing chemotherapy
- •3. Patients with prior wide-field radiotherapy (RT) affecting at least 20% of the bone marrow
- •4. Patients with > Grade 1 peripheral neuropathy per Common
- •Terminology Criteria for Adverse Events (CTCAE)
- •5. Patients with active or chronic corneal disorders, history of corneal
- •transplantation, or active ocular conditions requiring ongoing
- •treatment/monitoring such as uncontrolled glaucoma, wet age-related
- •macular degeneration requiring intravitreal injections, active diabetic
- •retinopathy with macular edema, macular degeneration, presence of
- •papilledema, and /or monocular vision
- •6. Patients with serious concurrent illness or clinically relevant active
- •infection, including, but not limited to the following:
- •a. Active hepatitis B or C infection (whether or not on active antiviral
- •b. HIV infection
- •c. Active Cytomegalovirus infection
- •d. Any other concurrent infectious disease requiring IV antibiotics within
- •2 weeks before starting study drug
- •Note: Testing at screening is not required for the above infections unless
- •clinically indicated
- •7. Patients with history of multiple sclerosis or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome)
- •8. Patients with clinically significant cardiac disease including, but not
- •limited to, any one of the following:
- •a. Myocardial infarction = 6 months prior to first dose
- •b. Unstable angina pectoris
- •c. Uncontrolled congestive heart failure (New York Heart Association >
- •d. Uncontrolled = Grade 3 hypertension (per CTCAE)
- •e. Uncontrolled cardiac arrhythmias
- •9. Patients assigned to PLD stratum only:
- •Left ventricular ejection fraction (LVEF) below the institutional limit of
- •normal as measured by echocardiography (ECHO) or multigated
- •acquisition (MUGA) scan
- •10. Patients with a history of hemorrhagic or ischemic stroke within six
- •months prior to randomization
- •11. Patients with a history of cirrhotic liver disease (Child-Pugh Class B
- •12. Patients with a previous clinical diagnosis of non-infectious
- •interstitial lung disease (ILD), including noninfectious pneumonitis
- •13. Patients with required use of folate-containing supplements (eg, folate deficiency)
- •14. Patients with prior hypersensitivity to monoclonal antibodies
- •15. Women who are pregnant or lactating
- •16. Patients with prior treatment with MIRV or other FRa-targeting agents
- •17. Patients with untreated or symptomatic central nervous system
- •(CNS) metastases
- •18. Patients with a history of other malignancy within 3 years prior to
- •randomization
- •Note: does not include tumors with a negligible risk for metastasis or
- •death (eg, adequately controlled basal-cell carcinoma or squamous-cell
- 另有 8 项未显示
研究者
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