Fallopian Tube Cancers, Ovarian Cancer, Primary Peritoneal Cancer
Conditions
Brief summary
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 Mirvetuximab Soravtansine in patients of Advanced Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer with expression of Folate Receptor α.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 folate receptor alpha (FRα). Data will be collected from medical records of patients who received MIRV as part of their routine clinical care.
Detailed description
This prospective, multicenter, observational cohort study aims to evaluate the real-world safety and effectiveness of mirvetuximab soravtansine (MIRV) in patients with advanced ovarian cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer with folate receptor alpha (FRα) expression. Approximately 400 patients are planned to be enrolled from approximately 40 centers in China. On Day 1 of each 21-day cycle (every 3 weeks, Q3W), all patients will receive mirvetuximab soravtansine at a dose of 6 mg/kg based on adjusted ideal body weight (AIBW), either as monotherapy or in combination with other anticancer agents per clinical guideline recommendations. The starting dose may be adjusted by the investigator based on the patient's actual clinical condition. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, loss to follow-up, death, or other protocol-specified events requiring treatment discontinuation, whichever occurs first. The screening period is up to 28 days. Safety assessments, including laboratory tests, ECOG performance status, vital signs, physical examinations, ophthalmologic examinations, adverse events, and concomitant medications, will be conducted every 3 weeks (± 1 week) during treatment. Tumor imaging assessments by CT or MRI per RECIST v1.1 will be performed every 2-3 cycles (± 7 days) to evaluate treatment response. Serum CA125 will be assessed within 14 days prior to the first dose, before each MIRV administration, and at each tumor imaging assessment (± 4 days). For patients who permanently discontinue MIRV treatment, an end-of-treatment visit will be conducted within 7 days, followed by a safety follow-up visit 30 days (± 2 to +14 days) after the last dose. Survival follow-up will be conducted every 3 months (± 1 month) thereafter until death, loss to follow-up, withdrawal of survival follow-up consent, or end of study, whichever occurs first. All data will be collected from routine clinical practice, entered into an electronic data capture (EDC) system, and analyzed using descriptive statistics. Time-to-event endpoints will be estimated using the Kaplan-Meier method. No additional interventions or study-mandated procedures are required beyond standard of care. This study is strictly observational and does not involve any investigational new drug application (IND) with the U.S. FDA.
Interventions
The 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.
Sponsors
NING LI-GYN
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who meet all of the following inclusion criteria are eligible to participate in the study: 1. Female patients aged ≥18 years. 2. Patients must have histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. 3. Patients must have PD on or after the most recent anti-cancer therapy. 4. Patients must have FRα expression confirmed by VENTANA FOLR1 (≥ 25% of tumor cells with intensity ≥ 2 + after FRα staining). 5. Patients must have normal major organ function and be suitable for MIRV monotherapy or combination therapy according to clinical recommendations 6. Patients must have at least 1 evaluable lesion per RECIST v1.1 (radiologically assessed by the investigator). 7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score must be 0-2. 8. All toxicities (except alopecia) associated with prior therapy must have recovered to ≤ Grade 1 per CTCAE v5.0. 9. Patients must have had completed any major surgery at least 4 weeks prior to the first dose of MIRV, and have recovered or stabilized from postoperative complications of prior surgery. 10. Patients must have expected survival of at least 12 weeks as assessed by the investigator. 11. Patients must sign ICF, and willingness and ability to comply with the study protocol, including scheduled treatment, regular follow-up, and examinations.
Exclusion criteria
* Patients who meet any of the following criteria may not be enrolled in the study: 1. Participation in other clinical studies during the same period. 2. Patient with known prior hypersensitivity to monoclonal antibody therapy or maytansinoids, or to study drug and/or any of its excipients. 3. 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. 4. Patients with prior treatment with MIRV or other FRα-targeting agents. (Only for patients in prospective cohort) 5. Pregnant or breast-feeding females. Women of childbearing potential must agree to use highly effective contraception while using study drug and for at least 7 months after the last dose of MIRV. 6. Current participation in any interventional study other than routine clinical practice. 7. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Grade ≥ 3 Treatment-Related Adverse Events (TRAEs) | From first dose to 30 days after last dose of MIRV | Incidence of Grade 3 or higher treatment-related adverse events (TRAEs) assessed by the investigator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator-assessed objective response rate (ORR) | From first dose until disease progression, up to approximately 24 months | 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 |
| Investigator-assessed duration of response (DOR) | From first documented response to disease progression or death, up to approximately 24 months. | 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. |
| Investigator-assessed progression-free survival (PFS) | From first dose to disease progression or death, up to approximately 24 months. | PFS defined as the time from the first dose to the first documented PD or death due to any cause, whichever occurs first, during the tumor assessment follow-up visit. |
| Overall survival (OS) | From first dose to death from any cause, up to approximately 36 months. | 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). |
| CA125 response | From first dose until disease progression, assessed per GCIG criteria, up to approximately 24 months. | CA125 response defined as a reduction in serum CA125 levels according to Gynecologic Cancer Intergroup (GCIG) criteria. |
| Incidence, severity and duration of treatment emergent adverse events (TEAEs) and TRAEs | From first dose to 30 days after last dose of MIRV. | Incidence, severity, duration, and dose modifications of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) assessed by investigators per CTCAE v5.0. |
Outcome results
None listed