Mirvetuximab Soravtansine Monotherapy in Platinum-Sensitive Epithelial, Peritoneal, and Fallopian… (NCT05041257) | Clinical Trial Compass
CompletedPhase 2
Mirvetuximab Soravtansine Monotherapy in Platinum-Sensitive Epithelial, Peritoneal, and Fallopian Tube Cancers
United States79 participantsStarted 2021-10-19
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Participants ≥ 18 years of age
✓. Participants must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
✓. Participants must have a confirmed diagnosis of high-grade serous epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer
✓. Participants 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
✓. Participants must have progressed radiographically on or after their most recent line of anticancer therapy
✓. Participants must have at least 1 lesion that meets the definition of measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (radiologically measured by the Investigator)
✓. Participants 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
✓. Participant's tumor must be positive for FRα expression as defined by the Ventana FOLR1 Assay
Exclusion criteria
✕. Participants with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/ borderline ovarian tumor
What they're measuring
1
Objective Response Rate (ORR) Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1])
. Participants with prior wide-field radiotherapy (RT) affecting at least 20% of the bone marrow
✕. Participants with \> Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE)
✕. Participants 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
✕. Participants with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:
✕. Active hepatitis B or C infection (whether or not on active antiviral therapy)