EUCTR2020-000179-19-BG进行中（未招募）1 期
SORAYA: A Phase 3, Single Arm Study of Mirvetuximab Soravtansine in Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor-Alpha Expression - SORAYA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 110
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 of the 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 Note: 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 anticancer therapy
- •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 FOLRI Assay
- •7.Patients must have at least 1 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, including at least 1 line of therapy containing bevacizumab, and for whom single-agent therapy is appropriate as the next line of treatment:
- •a.Adjuvant ± neoadjuvant considered 1 line of therapy
- •b.Maintenance therapy (eg, bevacizumab, PARP inhibitors) will be considered 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 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.Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
- •10.Patients must have completed prior therapy within the specified times below:
- •a.Systemic antineoplastic therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to first dose of mirvetuximab soravtansine
- •b.Focal radiation completed at least 2 weeks prior to first dose of mirvetuximab soravtansine
- •11.Patients must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities (except alopecia)
- •12.Patients must have completed any major surgery at least 4 weeks prior to first dose of mirvetuximab soravtansine 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 10^9/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
- •d.Serum creatinine = 1.5 x upper limit of normal (ULN)
- •e.Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3.0 x ULN
- •f.Serum bilirubin = 1.5 x ULN (patients with d
排除标准
- •1.Male patients
- •2.Patients with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumor
- •3. 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
- •4.Patients with prior wide-field radiotherapy (RT) affecting at least 20% of the bone marrow
- •5.Patients with > Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE)
- •6.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
- •7.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 therapy)
- •b.Human immunodeficiency virus (HIV) infection
- •c. Active cytomegalovirus infection
- •d.Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of mirvetuximab soravtansine Note: testing at screening is not required for the above infections unless clinically indicated
- •8.Patients with a history of multiple sclerosis (MS) or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome)
- •9.Patients with clinically significant cardiac disease including, but not limited to, any 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 > class II)
- •d.Uncontrolled = Grade 3 hypertension (per CTCAE)
- •e.Uncontrolled cardiac arrhythmias
- •10.Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment
- •11.Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)
- •12.Patients with a previous clinical diagnosis of noninfectious interstitial lung disease (ILD), including noninfectious pneumonitis
- •13.Patients requiring use of folate-containing supplements (eg, folate deficiency)
- •14.Patients with prior hypersensitivity to monoclonal antibodies (mAb)
- •15.Women who are pregnant or breastfeeding
- •16.Patients who received prior treatment with mirvetuximab soravtansine 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 enrollment
- •Note: patients with tumors with a negligible risk for metastasis or death (eg, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible
- •19. Prior known hypersensitivity reactions to study drugs and/or any of their excipients
研究者
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