Beaumont Hospital | Cancer Clinical Trials and Research Unit
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About
PICCOLO (IMGN853-0419) is a Phase 2 multicenter, open label study designed to evaluate the safety and efficacy of Mirvetuximab Soravtansine in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression.
Full description
Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to the tumor cells carrying a tumor-associated protein called folate receptor alpha (FRα). It is being developed for the treatment of subjects with recurrent platinum-sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression. Patients will have had at least 2 prior lines of therapy. These will include at least 2 lines of platinum-containing therapy or 1 line with a documented platinum allergy. FRα positivity will be defined by the Ventana FOLR1 (FOLR1- 2.1) CDx assay (Ventana FOLR1 Assay)
Enrollment
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Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
Patients ≥ 18 years of age
Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
Patients must have a confirmed diagnosis of high-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer
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
Patients must have progressed radiographically on or after their most recent line of anticancer therapy
Patients must have at least 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the Investigator)
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 FRα positivity
Patient's tumor must be positive for FRα expression as defined by the Ventana FOLR1 Assay
Prior anticancer therapy
Patients must have completed prior therapy within the specified times below:
Patients must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities (except alopecia)
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
Patients must have adequate hematologic, liver and kidney functions defined as:
Patients must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements
Women of childbearing potential (WCBP) must agree to use highly effective contraceptive method(s) while on MIRV and for at least 3 months after the last dose
WCBP must have a negative pregnancy test within the 4 days prior to the first dose of MIRV
Key Exclusion Criteria-
Patients with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumor
Patients with prior wide-field radiotherapy (RT) affecting at least 20% of the bone marrow
Patients with > Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE)
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
Patients with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:
Note: Testing at screening is not required for the above infections unless clinically indicated.
Patients with a history of multiple sclerosis (MS) or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome)
Patients with clinically significant cardiac disease including, but not limited to, any of the following:
Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment
Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)
Patients with a previous clinical diagnosis of noninfectious interstitial lung disease (ILD), including noninfectious pneumonitis
Patients requiring use of folate-containing supplements (eg, folate deficiency)
Patients with prior hypersensitivity to monoclonal antibodies (mAb)
Women who are pregnant or breastfeeding
Patients who received prior treatment with MIRV or other FRα-targeting agents
Patients with untreated or symptomatic central nervous system (CNS) metastases
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.
Prior known hypersensitivity reactions to study drugs and/or any of their excipients
Primary purpose
Allocation
Interventional model
Masking
79 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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