Study on Maintenance Therapy with Mirvetuximab Soravtansine and Olaparib for Ovarian Cancer

Inclusion Criteria

• Must be able to sign a consent form and agree to follow all study procedures.
• Women aged 18 years or older.
• Must have a good performance status, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Must have a confirmed diagnosis of high-grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
• Cancer must be sensitive to platinum-based treatments, with progression occurring more than 6 months after the last platinum therapy.
• Must have shown a complete or partial response, or stable disease, after the last platinum therapy.
• Must have available tumor tissue to confirm FRalpha positivity.
• Tumor must have high or medium FRalpha expression.
• Must have received at least one prior platinum-based chemotherapy regimen for recurrent disease.
• Most recent chemotherapy must have been platinum-based, with 4 to 8 completed cycles.
• Must have been tested for BRCA mutation and, if positive, have received a prior PARP inhibitor.
• Must have adequate blood, liver, and kidney function as determined by specific medical tests.

Exclusion Criteria

• Have a type of ovarian tumor that is not included in the study, such as clear cell or mucinous tumors.
• Have cancer that progressed during the most recent chemotherapy regimen.
• Have received chemotherapy or radiotherapy within 3 weeks before starting the study treatment.
• Have active or chronic eye disorders requiring ongoing treatment.
• Have certain blood disorders like myelodysplastic syndrome or acute myeloid leukemia.
• Have serious, uncontrolled medical conditions or infections.
• Have a history of multiple sclerosis or other demyelinating diseases.
• Have significant heart disease or recent heart attack.
• Have had a stroke within 6 months before joining the study.
• Have severe liver disease.
• Have lung disease or conditions affecting the lungs.
• Have persistent side effects from previous cancer treatments.
• Require certain medications that interfere with the study drugs.
• Have a history of allergic reactions to similar drugs.
• Have had a bone marrow or double umbilical cord blood transplant.
• Are pregnant or breastfeeding, or not willing to use effective contraception during the study.
• Have received prior treatment with MIRV or similar agents.
• Have conditions that interfere with taking oral medication.
• Have untreated or symptomatic brain metastases.
• Have had another cancer within the last 3 years, except for certain skin or cervical cancers.
• Have had recent surgery and not fully recovered.
• Are unable to comply with study procedures.