EUCTR2021-003592-34-DE进行中（未招募）1 期
PICCOLO: A Phase 2, Single Arm Study of Mirvetuximab Soravtansine in Recurrent Platinum-Sensitive, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor-Alpha Expression
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
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. Patients = 18 years of age
- •2. Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
- •3. Patients must have a confirmed diagnosis of high-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer
- •4. Patients must have platinum-sensitive disease defined as radiographic progression greater than 6 months from last dose of most recent platinum therapy
- •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
- •5. Patients must have progressed radiographically on or after their most recent line of anticancer therapy
- •6. Patients must have at least 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the Investigator)
- •7. 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
- •8. Patient’s tumor must be positive for FRa expression as defined by the Ventana FOLR1 Assay
- •9. Prior anticancer therapy
- •a. Patients must have received at least 2 prior systemic lines of platinum therapy and be considered by the Investigator as appropriate for single-agent non-platinum therapy (documentation required eg, high risk of hypersensitivity reaction; risk of further cumulative toxicity with additional platinum, including but not limited to myelosuppression, neuropathy, renal insufficiency or other)
- •Note: Patients who have had a documented platinum allergy may have had only 1 prior line of platinum
- •b. Patients may have received up to but no more than 1 prior independent non-platinum cytotoxic therapy
- •c. Patients must have had testing for BRCA mutation (tumor or germline) and, if positive, must have received a prior poly (ADP-ribose) polymerase (PARP) inhibitor as either treatment or maintenance therapy
- •d. Neoadjuvant ± adjuvant therapies are considered 1 line of therapy
- •e. Maintenance therapy (eg, bevacizumab, PARP inhibitors) will be considered part of the preceding line of therapy (ie, not counted independently)
- •f. Therapy changed due to toxicity in the absence of progression will be considered part of the same line (ie, not counted independently)
- •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 MIRV
- •b. Focal radiation completed at least 2 weeks prior to first dose of MIRV
- •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 MIRV and have recovered or stabilized from the side effects of prior surgery prior to first dose of MIRV
- •13. Patients must have adequate hematologic, liver and kidney functions defined as:
- •a. Absolute neutrophil count (ANC) = 1.5 x 10^9/L (1500/µL) without granulocyte colony-stimulating factor (G-CSF) in the prior 10 days or long-acting white blood cell (WBC) growth factors in the prior 20 days
- •b. Platelet count = 100 x 10^9/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 aminotransfe
排除标准
- •1. Patients with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumor
- •2. Patients with prior wide-field radiotherapy (RT) affecting at least 20% of the bone marrow
- •3. Patients with > Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE)
- •4. 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
- •5. 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. HIV infection
- •c. Active cytomegalovirus infection
- •d. Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of MIRV
- •Note: Testing at screening is not required for the above infections unless clinically indicated.
- •6. Patients with a history of multiple sclerosis (MS) or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome)
- •7. 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
- •8. Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment
- •9. Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)
- •10. Patients with a previous clinical diagnosis of noninfectious interstitial lung disease (ILD), including noninfectious pneumonitis
- •11. Patients requiring use of folate-containing supplements (eg, folate deficiency)
- •12. Patients with prior hypersensitivity to monoclonal antibodies (mAb)
- •13. Women who are pregnant or breastfeeding
- •14. Patients who received prior treatment with MIRV or other FRa-targeting agents
- •15. Patients with untreated or symptomatic central nervous system (CNS) metastases
- •16. 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.
- •17. Prior known hypersensitivity reactions to study drugs and/or any of their excipients
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