Real-World check: can a targeted ovarian cancer drug deliver outside clinical trials?
NCT ID NCT07690332
First seen Jul 08, 2026 · Last updated Jul 24, 2026 · Updated 2 times
Summary
This study tracks the safety and effectiveness of mirvetuximab soravtansine (MIRV), a drug that targets a protein called folate receptor alpha on cancer cells, in patients with advanced ovarian, fallopian tube, or primary peritoneal cancer. Researchers will observe 400 patients receiving MIRV as part of their routine care, focusing on side effects and how well the drug shrinks tumors. The goal is to see if the drug's benefits seen in clinical trials hold up in real-world settings, especially in Chinese patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mirvetuximab soravtansine (MIRV, Elahere)
- What this could lead to
- If successful, this study could confirm that MIRV works well and is safe in everyday clinical practice, especially for Chinese patients with advanced ovarian cancer.
- What could go wrong
- This is an observational study, not a controlled trial, so results may be less definitive. Side effects like eye problems, infusion reactions, and gastrointestinal issues are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer with expression of FRα
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 common terminology criteria for adverse events (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 informed consent form(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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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