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 range18 Years – 100 Years
SexFEMALE
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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 +/…
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