Folate Receptor-Alpha Positive Platinum-Resistant High-Grade Serous Epithelial Ovarian CancerNCT07687602
A Study to Evaluate Adverse Events and Change in Disease Activity of Mirvetuximab Soravtansine-gynx in Adults With Folate Receptor-Alpha Positive, Platinum-Resistant Ovarian Cancer in a Real-World Setting
An observational study of Folate Receptor-Alpha Positive Platinum-Resistant High-Grade Serous Epithelial Ovarian Cancer and Folate Receptor-Alpha Positive Platinum-Resistant Fallopian Tube Cancer, run by AbbVie.
Trial summary
Epithelial ovarian cancer, which includes fallopian tube and primary peritoneal cancers, is a lethal disease with 3,221 new cases reported in 2021 in Korea. The purpose of this study is to evaluate the adverse events and change in disease activity of mirvetuximab soravtansine-gynx (MIRV) in participants with folate… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Folate Receptor-Alpha Positive Platinum-Resistant High-Grade Serous Epithelial Ovarian Cancer, Folate Receptor-Alpha Positive Platinum-Resistant Fallopian Tube Cancer, Folate Receptor-Alpha Positive Platinum-Resistant Primary Peritoneal Cancer
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2026to Aug 2031
- 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: Adult participants who started treatment with MIRV according to the approved product label in South Korea.
Who may be able to join
- Folate receptor-alpha (FRα) positive (>=75% of cells with >=2+ staining intensity) platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens, according to the approved product label
Who cannot join
- Participants who are contraindicated from approved label of mirvetuximab soravtansine-gynx (MIRV).
- Participants who are currently participating in a clinical trial of another investigational drug.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Mirvetuximab Soravtansine-gynx in Patients With Folate Receptor-Alpha Positive, Platinum-Resistant, High-grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Epithelial ovarian cancer, which includes fallopian tube and primary peritoneal cancers, is a lethal disease with 3,221 new cases reported in 2021 in Korea. The purpose of this study is to evaluate the adverse events and change in disease activity of mirvetuximab soravtansine-gynx (MIRV) in participants with folate receptor-alpha (FRα) positive, platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. This study will evaluate the patient outcome in a routine clinical practice setting in South Korea.
MIRV is an antibody drug conjugate for high grade serious epithelial ovarian cancer in participants who have received one to three prior systemic treatment regimens. Participants with FRα positive platinum-resistant ovarian cancer who started treatment with MIRV according to the approved product label in Korea will be enrolled. Around 69 participants will be enrolled in the study in South Korea.
Read more
Participants will receive MIRV according to the approved local label. Participants will be followed for up to 62 months.
There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice.
- Conditions
- Folate Receptor-Alpha Positive Platinum-Resistant High-Grade Serous Epithelial Ovarian Cancer, Folate Receptor-Alpha Positive Platinum-Resistant Fallopian Tube Cancer, Folate Receptor-Alpha Positive Platinum-Resistant Primary Peritoneal Cancer
- Keywords
- Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer Mirvetuximab Soravtansine-gynx MIRV Elahere
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mirvetuximab Soravtansine-gynx | Participants will receive Mirvetuximab Soravtansine-gynx according to the Korean approved label and at the discretion of the treating physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AE)s
AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Measured: Up to Approximately Up to 62 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start30 Jun 2026 (estimated)
- Primary completionAug 2031 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Folate Receptor-Alpha Positive Platinum-Resistant High-Grade Serous Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687602
- Sponsor's protocol ID
- P25-646
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Mirvetuximab Soravtansine-gynx in Patients With Folate Receptor-Alpha Positive, Platinum-Resistant, High-grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT07687602
- Acronym / sponsor ID
- P25-646
- Conditions
- Folate Receptor-Alpha Positive Platinum-Resistant High-Grade Serous Epithelial Ovarian Cancer, Folate Receptor-Alpha Positive Platinum-Resistant Fallopian Tube Cancer, Folate Receptor-Alpha Positive Platinum-Resistant Primary Peritoneal Cancer
- Keywords
- Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer Mirvetuximab Soravtansine-gynx MIRV Elahere
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- Aug 2031 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 7 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.
Epithelial ovarian cancer, which includes fallopian tube and primary peritoneal cancers, is a lethal disease with 3,221 new cases reported in 2021 in Korea. The purpose of this study is to evaluate the adverse events and change in disease activity of mirvetuximab soravtansine-gynx (MIRV) in participants with folate receptor-alpha (FRα) positive, platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. This study will evaluate the patient outcome in a routine clinical practice setting in South Korea.
MIRV is an antibody drug conjugate for high grade serious epithelial ovarian cancer in participants who have received one to three prior systemic treatment regimens. Participants with FRα positive platinum-resistant ovarian cancer who started treatment with MIRV according to the approved product label in Korea will be enrolled. Around 69 participants will be enrolled in the study in South Korea.
Participants will receive MIRV according to the approved local label. Participants will be followed for up to 62 months.
There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mirvetuximab Soravtansine-gynx | – | –Participants will receive Mirvetuximab Soravtansine-gynx according to the Korean approved label and at the discretion of the treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants who started treatment with MIRV according to the approved product label in South Korea.
Key inclusion criteria (1 listed)
- Folate receptor-alpha (FRα) positive (>=75% of cells with >=2+ staining intensity) platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens, according to the approved product label
Key exclusion criteria (2 listed)
- Participants who are contraindicated from approved label of mirvetuximab soravtansine-gynx (MIRV).
- Participants who are currently participating in a clinical trial of another investigational drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Adverse Events (AE)s
Time frame: Up to Approximately Up to 62 Months
AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
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 7 Jul 2026.
Related trials for Folate Receptor-Alpha Positive Platinum-Resistant High-Grade Serous Epithelial Ovarian Cancer
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Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
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.
ABBVIE INC. study director
AbbVie
Questions about this trial
What is this clinical trial studying?
An observational study of Folate Receptor-Alpha Positive Platinum-Resistant High-Grade Serous Epithelial Ovarian Cancer and Folate Receptor-Alpha Positive Platinum-Resistant Fallopian Tube Cancer, run by AbbVie.
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 1 inclusion and 2 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 7 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?
Contact DaYoung Hwang (844-663-3742, dayoung.hwang@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AE)s (time frame: Up to Approximately Up to 62 Months). 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 7 Jul 2026.