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A Real-World Study of Mirvetuximab Soravtansine (MIRV) in Ovarian Cancer Patients of Expression of Folate Receptor α (MIRAS)

1. července 2026 aktualizováno: NING LI-GYN

A Real-World Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (MIRV) in Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer With Expression of Folate Receptor α

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

400

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer With Expression of Folate Receptor α

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
All Enrolled Patients Receiving MIRV-Based Therapy
This cohort includes all enrolled patients with FRα-expressing advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer who receive mirvetuximab soravtansine (MIRV)-based therapy in routine clinical practice. Patients may receive MIRV as monotherapy or in combination with other anticancer agents per physician's discretion and clinical practice guidelines.
Lék: Mirvetuximab Soravtansine (MIRV)
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.
Ostatní jména:
  • Elahere

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Incidence of Grade ≥ 3 Treatment-Related Adverse Events (TRAEs)
Časové okno: 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
From first dose to 30 days after last dose of MIRV

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Investigator-assessed objective response rate (ORR)
Časové okno: 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
From first dose until disease progression, up to approximately 24 months
Investigator-assessed duration of response (DOR)
Časové okno: 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.
From first documented response to disease progression or death, up to approximately 24 months.
Investigator-assessed progression-free survival (PFS)
Časové okno: 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.
From first dose to disease progression or death, up to approximately 24 months.
Overall survival (OS)
Časové okno: 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).
From first dose to death from any cause, up to approximately 36 months.
CA125 response
Časové okno: 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.
From first dose until disease progression, assessed per GCIG criteria, up to approximately 24 months.
Incidence, severity and duration of treatment emergent adverse events (TEAEs) and TRAEs
Časové okno: 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.
From first dose to 30 days after last dose of MIRV.

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
MIRV Treatment Patterns
Časové okno: Baseline and throughout treatment period.
Treatment patterns including patient characteristics at baseline, combination therapy regimens, and starting dose distribution.
Baseline and throughout treatment period.
Progression-Free Survival 2 (PFS2) and Subsequent Therapy
Časové okno: From first dose to progression on subsequent therapy or death, up to approximately 36 months.
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.
From first dose to progression on subsequent therapy or death, up to approximately 36 months.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

NING LI-GYN

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

20. července 2026

Primární dokončení (Odhadovaný)

30. září 2028

Dokončení studie (Odhadovaný)

30. září 2028

Termíny zápisu do studia

První předloženo

1. července 2026

První předloženo, které splnilo kritéria kontroly kvality

1. července 2026

První zveřejněno (Aktuální)

8. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

1. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • MIRV-20260305

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Mirvetuximab Soravtansine (MIRV)

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Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

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Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

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