Ovarian CancerMIRASNCT07690332
A Real-world Study of Mirvetuximab Soravtansine (MIRV) in Ovarian Cancer Patients of Expression of Folate Receptor α（FRα）
An observational study of Ovarian Cancer and Fallopian Tube Cancers, run by NING LI-GYN.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancers, Primary Peritoneal Cancer
- What is being tested?
- Mirvetuximab Soravtansine (MIRV)
- Type of treatment
- Injection or infusion
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2026to 30 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer with expression of FRα
Who may be able to join
- Patients who meet all of the following inclusion criteria are eligible to participate in the study:
- 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).
- Patients must have normal major organ function and be suitable for MIRV monotherapy or combination therapy according to clinical recommendations
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- Patients must have at least 1 evaluable lesion per RECIST v1.1 (radiologically assessed by the investigator).
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score must be 0-2.
- All toxicities (except alopecia) associated with prior therapy must have recovered to ≤ grade 1 per common terminology criteria for adverse events （CTCAE）v5.0.
- 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.
- Patients must have expected survival of at least 12 weeks as assessed by the investigator.
- Patients must sign informed consent form（ICF）, and willingness and ability to comply with the study protocol, including scheduled treatment, regular follow-up, and examinations.
Who cannot join
- Patients who meet any of the following criteria may not be enrolled in the study:
- 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)
- 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.
- Current participation in any interventional study other than routine clinical practice.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study
About this study
Official title: 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（FRα）
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.
Read the detailed description
This prospective, multicenter, observational cohort study aims to evaluate the real-world safety and effectiveness of MIRV in patients with advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer with 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 MIRV 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, eastern cooperative oncology group（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 computed tomography(CT ) or magnetic resonance imaging（MRI）per response evaluation criteria in solid tumors v1.1（RECIST v1.1） will be performed every 2-3 cycles (± 7 days) to evaluate treatment response. Serum carbohydrate antigen 125（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.
- Being tested
- Mirvetuximab Soravtansine (MIRV)
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirvetuximab Soravtansine (MIRV)Drug
Also called Elahere
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 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. Receives: Drug: Mirvetuximab Soravtansine (MIRV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade ≥ 3 treatment-related adverse events (TRAEs)
Incidence of grade 3 or higher treatment-related adverse events (TRAEs) assessed by the investigator
Measured: From first dose to 30 days after last dose of MIRV
Secondary outcomes (6)
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
Measured: From first dose until disease progression, up to approximately 24 months
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.
Measured: From first documented response to disease progression or death, up to approximately 24 months.
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.
Measured: From first dose to disease progression or death, up to approximately 24 months.
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).
Measured: From first dose to death from any cause, up to approximately 36 months.
CA125 response
CA125 response defined as a change in serum CA125 levels according to Gynecologic Cancer Intergroup (GCIG) criteria.
Measured: 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
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.
Measured: From first dose to 30 days after last dose of MIRV.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start20 Jul 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NING LI-GYN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, NING LI-GYN, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690332
- Sponsor's protocol ID
- MIRV-20260305
- Acronym
- MIRAS
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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（FRα）
- ClinicalTrials.gov ID
- NCT07690332
- Acronym / sponsor ID
- MIRAS / MIRV-20260305
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- NING LI-GYNUniversity, hospital or other
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective, multicenter, observational cohort study aims to evaluate the real-world safety and effectiveness of MIRV in patients with advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer with 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 MIRV 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, eastern cooperative oncology group（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 computed tomography(CT ) or magnetic resonance imaging（MRI）per response evaluation criteria in solid tumors v1.1（RECIST v1.1） will be performed every 2-3 cycles (± 7 days) to evaluate treatment response. Serum carbohydrate antigen 125（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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All enrolled patients receiving MIRV-based therapy | – | Drug: Mirvetuximab Soravtansine (MIRV)This cohort includes all enrolled patients with FRα-expressing advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer who receive 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer with expression of FRα
Key inclusion criteria (12 listed)
- Patients who meet all of the following inclusion criteria are eligible to participate in the study:
Key exclusion criteria (8 listed)
- Patients who meet any of the following criteria may not be enrolled in the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirvetuximab Soravtansine (MIRV)Also: ElahereThe 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. | Drug | All enrolled patients receiving MIRV-based therapy |
Primary outcome
Incidence of grade ≥ 3 treatment-related adverse events (TRAEs)
Time frame: 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
6 secondary outcomes
Investigator-assessed objective response rate (ORR)
Time frame: From first dose until disease progression, up to approximately 24 months
Investigator-assessed duration of response (DOR)
Time frame: From first documented response to disease progression or death, up to approximately 24 months.
Investigator-assessed progression-free survival (PFS)
Time frame: From first dose to disease progression or death, up to approximately 24 months.
Overall survival (OS)
Time frame: From first dose to death from any cause, up to approximately 36 months.
CA125 response
Time frame: 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
Time frame: From first dose to 30 days after last dose of MIRV.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Fallopian Tube Cancers, run by NING LI-GYN.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade ≥ 3 treatment-related adverse events (TRAEs) (time frame: From first dose to 30 days after last dose of MIRV). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.