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

Immunogen Biopharma (Ireland) Limited0 个研究点目标入组 75 人开始时间: 2022年9月21日最近更新: 2022年10月17日

适应症

试验速览

阶段: 2 期
状态: 进行中（未招募）
发起方
入组人数: 75

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

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:
•9.1. 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
•9.2. Patients may have received up to but no more than 1 prior independent non-platinum cytotoxic therapy
•9.3. 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
•9.4. Neoadjuvant ± adjuvant therapies are considered 1 line of therapy
•9.5. Maintenance therapy (eg, bevacizumab, PARP inhibitors) will be considered part of the preceding line of therapy (ie, not counted independently)
•9.6. 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:
•10.1. Systemic antineoplastic therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to first dose of MIRV
•10.2. 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:
•13.1. Absolute neutrophil count (ANC) = 1.5 x 10^9/L (1500/µL) without granulocyte colony-stimula

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 infectionc. Active cytomegalovirus infectiond. 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:
•7.1. Myocardial infarction = 6 months prior to first dose
•7.2. Unstable angina pectoris
•7.3. Uncontrolled congestive heart failure (New York Heart Association > class II)
•7.4. Uncontrolled = Grade 3 hypertension (per CTCAE)
•7.5. 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

研究者

发起方

Immunogen Biopharma (Ireland) Limited

相似试验

进行中（未招募）

1 期

A study to test mirvetuximab soravtansine in women with platinum sensitive, advanced epithelial ovarian, primary peritoneal, or fallopian tube cancers.Recurrent Platinum-Sensitive, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor-Alpha ExpressionMedDRA version: 21.0Level: PTClassification code 10061269Term: Malignant peritoneal neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10061328Term: Ovarian epithelial cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10016180Term: Fallopian tube cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2021-003592-34-DEImmunoGen, Inc.75

进行中（未招募）

1 期

EUCTR2021-003592-34-ITIMMUNOGEN, INC.75

进行中（未招募）

1 期

A study to test mirvetuximab soravtansine in women with platinum sensitive, advanced epithelial ovarian, primary peritoneal, or fallopian tube cancers.

EUCTR2021-003592-34-BEImmunoGen, Inc.75

已完成

2 期

Mirvetuximab Soravtansine Monotherapy in Platinum-Sensitive Epithelial, Peritoneal, and Fallopian Tube CancersPeritoneal CancerFallopian Tube CancerOvarian Cancer

NCT05041257AbbVie79

进行中（未招募）

1 期

A study to test mirvetuximab soravtansine in women with platinum-resistant, advanced epithelial ovarian, primary peritoneal, or fallopian tube cancersAdvanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor-Alpha ExpressionMedDRA version: 20.0Level: PTClassification code 10061328Term: Ovarian epithelial cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10016180Term: Fallopian tube cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10061269Term: Malignant peritoneal neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2020-000179-19-ITIMMUNOGEN, INC.110