Platinum-Resistant FRα-Positive Ovarian CancerMIRELANCT07896421
Real-World Study of Mirvetuximab Soravtansine in Adult Participants With Platinum-Resistant FRα-Positive Ovarian, Fallopian Tube, and Peritoneal Cancer
An observational study of Platinum-Resistant FRα-Positive Ovarian Cancer and Platinum-Resistant FRα-Positive Fallopian Tube Cancer, run by AbbVie at 1 site in Austria.
Trial summary
Epithelial ovarian cancer, which includes fallopian tube and primary peritoneal cancer, is the deadliest gynecologic malignant neoplasm. The goal of this observational study is to collect real-world data on treatment patterns, clinical effectiveness, participant characteristics, biomarker testing, and health-related… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Platinum-Resistant FRα-Positive Ovarian Cancer, Platinum-Resistant FRα-Positive Fallopian Tube Cancer, Platinum-Resistant FRα-Positive Peritoneal Cancer
- How many people
- 500 participants
- Where
- 1 siteAustria
- Study dates
- 21 Oct 2026to Apr 2030
- 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 with FRα positive status, platinum resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer treated with mirvetuximab soravtansine according to local label.
Who may be able to join
- Participants scheduled to be treated with mirvetuximab soravtansine in accordance with the local label, with treatment decision made independently before study enrollment
- Signed informed consent and willingness to comply with study requirements including patient-reported outcome data collection
Who cannot join
- Any condition included in the contraindications section of the approved local mirvetuximab soravtansine label
- Participation in a concurrent interventional clinical trial from enrollment throughout the study
- Unwillingness or inability to comply with study requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medizinische Universitaet Wien /ID# 282657
Vienna, 1090
About this study
Official title: Multi-country Real-World Observational Study of MIrvetuximab Soravtansine in Treating Platinum-REsistant FRALphA Positive Ovarian, Fallopian Tube, and Peritoneal Cancer- MIRELA
Epithelial ovarian cancer, which includes fallopian tube and primary peritoneal cancer, is the deadliest gynecologic malignant neoplasm. The goal of this observational study is to collect real-world data on treatment patterns, clinical effectiveness, participant characteristics, biomarker testing, and health-related quality of life in participants with FRα-positive platinum-resistant ovarian, fallopian tube, and peritoneal cancer receiving mirvetuximab soravtansine.
Mirvetuximab soravtansine (MIRV) is an approved antibody-drug conjugate being studied for the treatment of FRα-positive platinum-resistant ovarian, fallopian tube, and peritoneal cancer. Adult participants with FRα-positive platinum-resistant cancer who have received 1-3 prior treatment lines and are scheduled to receive MIRV as monotherapy will be enrolled. Approximately 500 participants will be enrolled at sites globally.
Read more
Participants will receive intravenous infusions of mirvetuximab soravtansine as monotherapy according to the local product label and treating physician's decision. The total study duration per participant may be up to 18 months of follow-up.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
- Conditions
- Platinum-Resistant FRα-Positive Ovarian Cancer, Platinum-Resistant FRα-Positive Fallopian Tube Cancer, Platinum-Resistant FRα-Positive Peritoneal Cancer
- Keywords
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Platinum-Resistant, Mirvetuximab Soravtansine, MIRV, FRα-Positive
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Mirvetuximab Soravtansine (MIRV) | Participants with FRα positive platinum-resistant ovarian, primary peritoneal or fallopian tube cancer and are scheduled to receive treatment with MIRV in accordance with the local label of the participating country. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Duration of MIRV Among Participants With Platinum-Resistant FRα-Positive Ovarian Cancer
Treatment duration of MIRV is defined as (the maximum end date of MIRV dosing date - the minimum start date of MIRV +21).
Measured: Up to approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start21 Oct 2026 (estimated)
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platinum-Resistant FRα-Positive 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
- 500 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
- NCT07896421
- Sponsor's protocol ID
- P26-294
- Acronym
- MIRELA
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-country Real-World Observational Study of MIrvetuximab Soravtansine in Treating Platinum-REsistant FRALphA Positive Ovarian, Fallopian Tube, and Peritoneal Cancer- MIRELA
- ClinicalTrials.gov ID
- NCT07896421
- Acronym / sponsor ID
- MIRELA / P26-294
- Conditions
- Platinum-Resistant FRα-Positive Ovarian Cancer, Platinum-Resistant FRα-Positive Fallopian Tube Cancer, Platinum-Resistant FRα-Positive Peritoneal Cancer
- Keywords
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Platinum-Resistant, Mirvetuximab Soravtansine, MIRV, FRα-Positive
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2026 (estimated)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 27 Oct 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 cancer, is the deadliest gynecologic malignant neoplasm. The goal of this observational study is to collect real-world data on treatment patterns, clinical effectiveness, participant characteristics, biomarker testing, and health-related quality of life in participants with FRα-positive platinum-resistant ovarian, fallopian tube, and peritoneal cancer receiving mirvetuximab soravtansine.
Mirvetuximab soravtansine (MIRV) is an approved antibody-drug conjugate being studied for the treatment of FRα-positive platinum-resistant ovarian, fallopian tube, and peritoneal cancer. Adult participants with FRα-positive platinum-resistant cancer who have received 1-3 prior treatment lines and are scheduled to receive MIRV as monotherapy will be enrolled. Approximately 500 participants will be enrolled at sites globally.
Participants will receive intravenous infusions of mirvetuximab soravtansine as monotherapy according to the local product label and treating physician's decision. The total study duration per participant may be up to 18 months of follow-up.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mirvetuximab Soravtansine (MIRV) | – | –Participants with FRα positive platinum-resistant ovarian, primary peritoneal or fallopian tube cancer and are scheduled to receive treatment with MIRV in accordance with the local label of the participating country. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with FRα positive status, platinum resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer treated with mirvetuximab soravtansine according to local label.
Key inclusion criteria (2 listed)
- Participants scheduled to be treated with mirvetuximab soravtansine in accordance with the local label, with treatment decision made independently before study enrollment
- Signed informed consent and willingness to comply with study requirements including patient-reported outcome data collection
Key exclusion criteria (3 listed)
- Any condition included in the contraindications section of the approved local mirvetuximab soravtansine label
- Participation in a concurrent interventional clinical trial from enrollment throughout the study
- Unwillingness or inability to comply with study requirements
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
Treatment Duration of MIRV Among Participants With Platinum-Resistant FRα-Positive Ovarian Cancer
Time frame: Up to approximately 18 months
Treatment duration of MIRV is defined as (the maximum end date of MIRV dosing date - the minimum start date of MIRV +21).
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 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Platinum-Resistant FRα-Positive Ovarian Cancer
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
Not yet recruitingObservational study
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
Folate Receptor-Alpha Positive Platinum-Resistant High-Grade Serous Epithelial Ovarian Cancer, Folate Receptor-Alpha Positive Platinum-Resistant Fallopian Tube 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Platinum-Resistant FRα-Positive Ovarian Cancer and Platinum-Resistant FRα-Positive Fallopian Tube Cancer, run by AbbVie at 1 site in Austria.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Farah Khallaf (+1 (630) 2636202, farah.khallaf@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Duration of MIRV Among Participants With Platinum-Resistant FRα-Positive Ovarian Cancer (time frame: Up to approximately 18 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 27 Oct 2026.