An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib (NCT05887609) | Clinical Trial Compass
RecruitingPhase 2
An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib
United States53 participantsStarted 2023-10-03
Plain-language summary
The Principal Investigator hypothesizes the combination of MIRV and Olaparib is an effective, and tolerable, maintenance therapy strategy in platinum sensitive recurrent ovarian cancer.
Who can participate
Age range
18 Years – 100 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Provision to sign and date the consent form
* Stated willingness to comply with all study procedures and be available for the duration of the study
* Be a woman aged ≥18 years of age
* Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
* Patients must have a confirmed diagnosis of high-grade serous or endometrioid EOC, primary peritoneal cancer, or fallopian tube cancer
* Patients must have platinum-sensitive disease defined as radiographic progression greater than 6 months from last dose of prior platinum therapy (not inclusive of current/most recent platinum therapy)
* Patients must have had documented complete or partial response, or stable disease, as defined by RECIST 1.1, from last line of platinum therapy
* Patients must have available archival tissue block or slides to confirm FRalpha positivity
* Patients' tumor must have FRalpha high or medium expression
* Prior anticancer therapy:
* Patients must have received at least one prior platinum-based chemotherapy regimen for platinum sensitive recurrent disease.
* Most recent prior chemotherapy regimen must have consisted of at least 4 completed cycles and no more than 8 completed cycles
* Most recent prior chemotherapy regimen must have been platinum based
* Patients must have had testing for BRCA mutation (tumor or germline) and, if positive, must have received a prior PARP inhibitor as either treatment or maintenance therapy
* Neoadjuvant +/…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To measure progression free survival (PFS) with the use of MIRV combined with Olaparib in women with recurrent platinum sensitive ovarian, peritoneal, and fallopian tube cancer.
Timeframe: Through study completion, average of 12 months