Sarasota Memorial Hospital | Clinical Research Center
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About
This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine (MIRV) vs. IC chemotherapy in participants with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Participants will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. The FRα positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay.
Full description
Participants will be randomized to either MIRV or IC chemotherapy (paclitaxel, PEGylated liposomal doxorubicin, or topotecan).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Female participants ≥ 18 years of age
Participants must have a confirmed diagnosis of high-grade serious epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
Participants must have platinum-resistant disease:
Participants must have progressed radiographically on or after their most recent line of therapy
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 (FOLR-2.1) CDx assay
Participants must have at least one lesion that meets the definition of measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (radiologically measured by the Investigator)
Participants must have received at least 1 but no more than 3 prior systemic lines of anticancer therapy, and for whom single-agent therapy is appropriate as the next line of treatment:
Participant must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
Time from prior therapy:
Participants must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities
Major surgery must be completed at least 4 weeks prior to first dose and have recovered or stabilized from the side effects of prior surgery
Participants must have adequate hematologic, liver and kidney functions defined as:
Participants or their legally authorized representative 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 study drug and for at least 3 months after the last dose of MIRV or at least 6 months after the last dose of paclitaxel, pegylated liposomal doxorubicin, or topotecan
WCBP must have a negative pregnancy test within 4 days prior to the first dose of study drug
Exclusion criteria
Participants with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade or borderline ovarian tumor
Participants 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
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) v5.0
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:
Participants with history of multiple sclerosis or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome)
Participants with clinically significant cardiac disease including, but not limited to, any one of the following:
Participants assigned to PLD stratum only: Left ventricular ejection fraction (LVEF) below the institutional limit of normal as measured by echocardiography (ECHO) or multigated acquisition (MUGA) scan
Participants with a history of hemorrhagic or ischemic stroke within six months prior to randomization
Participants with a history of cirrhotic liver disease (Child-Pugh Class B or C)
Participants with a previous clinical diagnosis of non-infectious interstitial lung disease (ILD), including noninfectious pneumonitis
Participants with required use of folate-containing supplements (for example, folate deficiency)
Participants with prior hypersensitivity to monoclonal antibodies
Women who are pregnant or lactating
Participants with prior treatment with MIRV or other FRα-targeting agents
Participants with untreated or symptomatic central nervous system (CNS) metastases
Participants with a history of other malignancy within 3 years prior to randomization. Note: does not include tumors with a negligible risk for metastasis or death (for example, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast
Prior known hypersensitivity reactions to study drugs and/or any of their excipients
People who are detained through a court or administrative decision, receiving psychiatric care against their will, adults who are the subject of a legal protection order (under tutorship/curatorship), people who are unable to express their consent, and people who are subject to a legal guardianship order
Simultaneous participation in another research study, in countries or localities where this is the health authority guidance
Primary purpose
Allocation
Interventional model
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453 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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