Phase 3 Ovarian Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are at least 18 years old and meet the legal age of consent in the country where the trial is taking place.
• People who have been diagnosed with a specific type of ovarian cancer (including primary peritoneal or fallopian tube cancer), confirmed by laboratory testing, with one of the following cancer types: high grade serous, high grade endometrioid, clear cell carcinoma, or carcinosarcoma — and whose cancer has stopped responding to platinum-based chemotherapy (confirm with trial site for exact definition of "platinum-resistance").
• People who have received at least 1 but no more than 4 prior rounds of cancer treatment (with specific rules about how prior treatments are counted — confirm with trial site).
• People who have previously been treated with certain standard therapies (mirvetuximab soravtansine, bevacizumab, and/or a PARP inhibitor), unless there was a documented medical reason those treatments could not be used, or they were not available or funded in the person's country.
• People who have at least one measurable area of cancer that can be tracked on scans, as assessed by the trial doctor.
• People who have provided a suitable tumor tissue sample for central laboratory testing of certain protein markers (B7-H4, folate receptor alpha, and PD-L1), with specific requirements varying depending on the country (confirm with trial site).
• People who are eligible to receive at least one of the standard treatment options offered in the trial's comparison group, as determined by their doctor.
• Women who are not pregnant and not breastfeeding, and who either cannot become pregnant or who agree to use a highly effective form of contraception (with a failure rate of less than 1% per year) starting 30 days before treatment begins, throughout the trial, and for at least 8 months after the last dose — and who agree not to donate eggs during this time.
• Women who could potentially become pregnant must have a negative pregnancy test within 24 hours before the first dose of treatment.
• People who are well enough to carry out everyday activities with little or no limitation, based on a standard medical assessment scale (ECOG performance status of 0 or 1).
• People whose heart, liver, kidneys, and other organs are functioning adequately, as determined by the trial doctor.
• People who are able to understand and sign an informed consent form.

Who may not be able to join:

• People whose cancer did not respond at all to their very first platinum-based chemotherapy, or whose cancer progressed within 3 months of finishing that first treatment.
• People who have had another cancer (other than the one being studied) that was active or required treatment within the past 3 years — with exceptions for certain minor skin cancers or cancers considered fully cured by the treating doctor.
• People who have a known allergy or sensitivity to any of the study drugs or their ingredients.
• People who have untreated cancer that has spread to the brain or central nervous system, or brain/central nervous system metastases that are growing or causing new symptoms (people with previously treated and stable brain metastases who have been off steroid treatment for at least 14 days may still be considered — confirm with trial site).
• People who currently have, or have a history of, inflamed or scarred lung tissue (interstitial lung disease or pneumonitis).
• People who are still experiencing side effects from previous cancer treatment that have not returned to a mild level (Grade 1 or below), with some exceptions such as hair loss, certain nerve-related side effects (Grade 2 neuropathy), or hormone conditions managed with replacement therapy.
• People with serious unstable medical conditions, infections, or serious psychiatric conditions that could affect their safety or ability to follow the trial requirements.
• People assigned to receive the pembrolizumab-containing treatment option who have previously had a severe immune-related reaction (Grade 3 or higher) from immunotherapy, or certain serious nerve, skin, or heart reactions of any severity from prior immunotherapy.
• People assigned to receive bevacizumab as part of their treatment who have a history of uncontrolled high blood pressure, blood clots in arteries, certain bowel problems, abnormal connections between organs (fistulas), poor wound healing, certain bleeding conditions, significant kidney protein loss, or jaw bone problems.
• People who have had major surgery within 28 days before starting the trial, or targeted radiation therapy within 21 days before starting.
• People who have received an experimental (investigational) treatment within 30 days before starting the trial.
• People who have received chemotherapy, immunotherapy, hormone therapy, targeted therapy, or other anti-cancer drugs within 30 days (or 5 half-lives of the drug, whichever is shorter) before starting the trial, or who would need to continue these treatments during the trial.
• People who have ever previously been treated with a type of chemotherapy called topoisomerase I inhibitors (such as topotecan), or certain antibody-drug combinations (ADCs) with a similar mechanism, or any treatment specifically targeting the B7-H4 protein.
• People who have received a live vaccine within 30 days before starting the trial.
• People who have had a blood transfusion or received certain blood-stimulating medications within 14 days before starting the trial.
• People assigned to receive a specific chemotherapy drug called PLD whose heart pumping function is below a certain level on testing (confirm with trial site for the specific threshold).

Important: Always verify eligibility with the trial site directly before applying.