Phase 3 Ovarian Cancer Trial, Recruiting

Written by an AI model from the 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 diagnosed with uterine carcinosarcoma (also called Malignant Mixed Mullerian Tumor) that has come back or continued to grow.
• The diagnosis must have been confirmed by a specialist pathologist looking at tissue from the original tumor or a later biopsy.
• A stored tissue sample from the original diagnosis (or from when the cancer returned) must be available.
• The cancer must be measurable and shown to be growing according to standard imaging guidelines (RECIST 1.1).
• People whose cancer did not respond to, or came back after, at least one chemotherapy treatment that included platinum-based drugs.
• People who have had exactly one chemotherapy treatment plan for this cancer (which may have included radiation alongside chemotherapy, or follow-up maintenance therapy).
• People who are not currently being treated for an active infection with antibiotics.
• Any hormone therapy aimed at the cancer must have been stopped at least one week before starting the trial (hormone replacement therapy for other reasons may continue).
• People who are generally well enough to carry out light activity and care for themselves (ECOG Performance Status of 0 or 1 — confirm with trial site what this means for a specific situation).
• People with a life expectancy of more than 2 months.
• People whose blood counts meet minimum levels: platelets at or above 100,000/mm³, neutrophils (a type of white blood cell) at or above 1,500/mm³, and haemoglobin above 9 g/dL.
• People whose liver and kidney function tests fall within acceptable ranges as determined by blood tests (confirm specific values with trial site).
• People whose blood clotting results are within acceptable ranges, or who are on blood thinners with their levels kept within the intended treatment range.
• People with normal blood pressure, or whose blood pressure is well controlled (systolic at or below 140 mmHg and/or diastolic at or below 90 mmHg).
• People taking corticosteroid medication, provided the dose has been stable and at or below 10 mg/day (prednisone equivalent) for at least 4 weeks before starting the trial.
• People who agree not to donate blood during the trial or for 90 days after the last dose of the study treatment.
• People who are not able to become pregnant, or people of childbearing potential who have a negative pregnancy test within 72 hours before starting the treatment and who agree to use highly effective contraception from screening through to 4 months after the last dose.
• People who agree not to breastfeed during the trial and for 4 months after the last dose.
• People who are able to swallow and take oral (by mouth) medications.
• Women aged 18 or older at the time of signing the consent form.
• People who have read and signed the approved consent form agreeing to take part.
• For participants in France only: people who are affiliated with, or covered by, a French social security scheme.

Who may not be able to join:

• People who are already enrolled in another interventional clinical trial (trials involving only biological samples may be considered with sponsor approval — confirm with trial site).
• People who have previously been treated with niraparib, any other PARP inhibitor drug, or any PD-1/PD-L1 immunotherapy drug.
• People who have received investigational therapy, immunotherapy, chemotherapy, or biological therapy within the past 4 weeks (or within a period covering at least 5 half-lives of the drug, whichever is longer), or radiotherapy within the past 4 weeks before starting the trial.
• People who have had major surgery within 3 weeks before starting the trial, or who have not yet recovered from surgery.
• People who have already received more than 3 separate cytotoxic (cell-killing) chemotherapy treatments for this cancer.
• People who still have ongoing significant side effects (greater than Grade 1) from previous treatment.
• People with serious heart or blood vessel conditions, including uncontrolled high blood pressure, a heart attack or unstable chest pain within the past 6 months, significant heart rhythm problems, moderate or severe heart failure, significant circulation problems in the limbs, or a stroke within the past 6 months.
• People with other serious ongoing illnesses that, in the doctor's judgement, would make participation unsafe — including serious neurological, psychiatric, infectious, liver, kidney, or digestive conditions, or significant abnormal blood test results.
• People experiencing bowel obstruction that requires intravenous nutrition or fluids, or any digestive condition (including difficulty swallowing) that would prevent proper absorption of the study drugs.
• People who had a severe (Grade 3 or higher) immune-related reaction to a previous immunotherapy treatment.
• People who have received radiation therapy covering more than 20% of the bone marrow within 2 weeks before starting the trial, or any radiation within 1 week before starting.
• People who have a condition that weakens the immune system, or who have been taking steroid medication at more than 10 mg/day (prednisone equivalent) or other immune-suppressing drugs within the 7 days before starting the trial.
• People living with HIV may be excluded unless they meet specific requirements around viral load, CD4 cell count, and stable HIV treatment — these requirements are detailed and would need to be assessed by the trial site directly.
• People with active hepatitis B or hepatitis C infection.
• People with an active autoimmune disease that has required systemic medical treatment (such as immune-suppressing drugs) within the past 2 years. Replacement hormone therapies (such as thyroid medication or insulin) are not considered systemic treatment for this purpose.
• People with a history of interstitial lung disease (scarring or inflammation of the lungs).
• People who have received a live vaccine within 30 days before starting the trial.
• People who have received a blood transfusion (platelets or red blood cells) within 4 weeks before starting the trial.
• People who have received growth factor injections (such as G-CSF or erythropoietin) within 4 weeks before starting the trial.
• People with a known history of myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML).
• People with cancer that has spread to the brain and is causing symptoms, or cancer affecting the membranes around the brain and spinal cord.
• People who have had another invasive cancer within the past 3 years, or who currently have another invasive cancer, with the exception of certain non-melanoma skin cancers. People whose prior cancer treatment would conflict with this trial are also ineligible.
• People with a known serious allergic reaction to the study drugs or their ingredients.
• People for whom psychological, family, social, or geographical factors could make it difficult to follow the trial schedule and requirements.
• People currently under psychiatric care or admitted to a health or social care institution.
• People whose freedom is restricted by a legal or administrative decision.
• People under a legal protection measure or who are unable to give their own consent.

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