A Real-world Study of Mirvetuximab Soravtansine (MIRV) in Ovarian Cancer Patients of Expression of Folate Receptor α（FRα）
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorNING LI-GYN
About this trial
Mirvetuximab soravtansine (MIRV) is an antibody-drug conjugate approved for the treatment of ovarian cancer. However, real-world data on its safety and effectiveness in routine clinical practice are limited, especially in the Chinese patient population. MIRAS is a multicenter, prospective，observational, real-word study of MIRV in patients of advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer with expression of FRα.This study aims to evaluate the real-world safety and efficacy of MIRV in patients with advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer that expresses FRα. Data will be collected from medical records of patients who received MIRV as part of their routine clinical care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients aged ≥18 years.
Patients must have histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
Patients must have PD on or after the most recent anti-cancer therapy.
Patients must have FRα expression confirmed by VENTANA FOLR1 (≥ 25% of tumor cells with intensity ≥ 2 + after FRα staining).
Disqualifiers
Participation in other clinical studies during the same period.
Patient with known prior hypersensitivity to monoclonal antibody therapy or maytansinoids, or to study drug and/or any of its excipients.
Patients with active or chronic corneal disorders, history of corneal transplant, or active ocular conditions requiring ongoing treatment/monitoring such as uncontrolled glaucoma, wet age-related macular degeneration requiring treatment with intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema and/or monocular vision.
Patients with prior treatment with MIRV or other FRα-targeting agents. (Only for patients in prospective cohort)
Trial population
Patients with advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer with expression of FRα
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Mirvetuximab Soravtansine (MIRV)
DrugThe recommended dose of MIRV is 6 mg/kg based on adjusted ideal body weight (AIBW), administered intravenously on Day 1 of each 21-day cycle. Investigators may adjust the starting dose based on the patient's actual clinical condition. Premedication including antipyretics, antihistamines, corticosteroids, and antiemetics is administered prior to each infusion to reduce infusion-related reactions and gastrointestinal adverse events. Prophylactic corticosteroid eye drops and artificial tears are used to manage ocular toxicity. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first. Dose reductions (to 5 mg/kg or 4 mg/kg AIBW) are permitted for management of adverse events per protocol-specified criteria.
Treatment groups
400 Participants
are divided into 1 treatment groupGroup A: All enrolled patients receiving MIRV-based therapy1 intervention
Trial outcomes
Primary outcomes
1
Incidence of grade ≥ 3 treatment-related adverse events (TRAEs)
Incidence of grade 3 or higher treatment-related adverse events (TRAEs) assessed by the investigator
Time frame
From first dose to 30 days after last dose of MIRVSecondary outcomes
1
Investigator-assessed objective response rate (ORR)
objective response rate defined as the proportion of patients with confirmed complete response (CR) or partial response (PR) per RECIST v1.1, assessed by investigators, with responses confirmed at least 4 weeks after initial response
Time frame
From first dose until disease progression, up to approximately 24 months2
Investigator-assessed duration of response (DOR)
DOR defined as the time from first documented CR or PR (whichever occurs first) to disease progression according to RECIST v1.1 or death, whichever occurs first, assessed by investigators.
Time frame
From first documented response to disease progression or death, up to approximately 24 months.3
Investigator-assessed progression-free survival (PFS)
PFS defined as the time from the first dose to the first documented disease progression（PD）or death due to any cause, whichever occurs first, during the tumor assessment follow-up visit.
Time frame
From first dose to disease progression or death, up to approximately 24 months.4
Overall survival (OS)
OS defined as the time from the first dose to death due to any cause (for patients who have been lost to follow-up prior to death, the time of last follow-up is usually used as the time of death).
Time frame
From first dose to death from any cause, up to approximately 36 months.Other outcomes
1
MIRV Treatment Patterns
Treatment patterns including patient characteristics at baseline, combination therapy regimens, and starting dose distribution.
Time frame
Baseline and throughout treatment period.2
Progression-Free Survival 2 (PFS2) and Subsequent Therapy
Subsequent therapy after progression on MIRV and progression-free survival 2 (PFS2), defined as the time from first dose to progression on subsequent therapy or death.
Time frame
From first dose to progression on subsequent therapy or death, up to approximately 36 months.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
NING LI-GYN
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor institution
Source ClinicalTrials.gov
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