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 have been diagnosed with a specific type of ovarian, fallopian tube, or primary peritoneal cancer (high grade serous or endometrioid type) that has reached an advanced stage (FIGO stage III or IV), confirmed by CT scan or MRI.
• People who have been recommended to receive platinum-based chemotherapy before surgery (3–4 cycles), with or without an additional drug called bevacizumab, and who are planned to have interval surgery to remove as much cancer as possible, followed by more chemotherapy and a maintenance drug called niraparib.
• People with stage IV disease whose cancer outside the abdomen has either completely responded to treatment on pre-surgery scans, or whose doctor considers it surgically removable.
• People whose tumour has tested positive for a genetic feature called HRD/LOH, or who carry certain gene mutations (such as BRCA, RAD51C, RAD51D, BRIP1, or BARD) — these results must be available before joining the trial.
• People whose surgery successfully removed all visible cancer, or left behind no more than 1.0 cm of visible disease.
• People whose blood counts, kidney, liver, and nerve function meet specific minimum levels set by the trial (confirm with trial site for exact values).
• People with an overall health and activity level rated as 0 or 1 on the standard medical performance scale (meaning fully active or able to carry out light work).
• People aged over 18 years.
• People with a life expectancy of more than 3 months.
• People who could potentially become pregnant must have a negative pregnancy blood test within 28 days before surgery, and must use a highly effective form of contraception during the study and for 6 months after the last dose of niraparib, as well as agree to monthly pregnancy tests while on niraparib. People who have not had a menstrual period for more than 1 year, or who have been surgically sterilised, are considered not at risk of pregnancy.
• People whose blood pressure is normal or well controlled with treatment (systolic no higher than 140 mmHg and diastolic no higher than 90 mmHg) before starting niraparib.
• People who are taking corticosteroid medications, provided their dose has been stable for at least 4 weeks before joining the trial.
• People who agree not to donate blood during the study or for 90 days after the last dose of study treatment.
• People living with HIV may be eligible if their immune cell count and viral load meet specific levels, they have not had certain serious HIV-related infections or cancers recently, and they have been on approved HIV treatment for at least 4 weeks before enrolling (confirm with trial site).
• People who have signed an informed consent form, or whose legal representative has done so on their behalf.

Who may not be able to join:

• People whose ovarian cancer is of a different type, such as low-grade serous, clear cell, mucinous, non-epithelial, or borderline tumour types.
• People who have received any previous treatment for ovarian cancer other than the first 3–4 cycles of platinum-based chemotherapy before surgery (prior bevacizumab alongside that chemotherapy is permitted, but must be stopped at least 28 days before surgery).
• People whose tumour has tested negative for the HRD/LOH genetic feature.
• People who are not suitable for interval surgery because their cancer continued to grow during chemotherapy, as confirmed by a CT scan or MRI taken within 35 days of the planned surgery.
• People who are not suitable for interval surgery due to other existing health conditions, as assessed by the treating doctor.
• People with stage IV disease whose cancer outside the abdomen has not fully responded to pre-surgery treatment and is not considered surgically removable.
• People with a history of certain blood cancers (Myelodysplastic Syndrome or Acute Myeloid Leukaemia).
• People who are pregnant or breastfeeding.
• People who have had a serious infection requiring intravenous antibiotics within 2 weeks of the planned trial start date.
• People with other serious or uncontrolled medical conditions.
• People whose cancer has spread to the brain or central nervous system.
• People with uncontrolled insulin-dependent diabetes or a pre-existing kidney condition.
• People who have experienced hearing loss as a result of previous platinum-based chemotherapy.
• People with a history of a condition called Posterior Reversible Encephalopathy Syndrome (PRES), which is a rare neurological condition (confirm with trial site).
• People with active liver or bile duct disease (certain stable or minor liver conditions may be acceptable — confirm with trial site).
• People with significant digestive system problems that affect how the body absorbs medication, or who have had major stomach or bowel surgery unrelated to ovarian cancer.
• People with significant heart or blood vessel problems, including uncontrolled high blood pressure, a heart attack or unstable chest pain within the past 6 months, certain heart rhythm problems, moderate-to-severe heart failure, significant circulation problems in the limbs, or a stroke within the past 6 months.
• People with an elevated risk of bleeding, including those who have had a major injury or major surgery in the past 28 days, or a bleed in the brain or a serious haemorrhage in the past 3 months.
• People with active hepatitis B infection, unless it is stably managed with specific antiviral medications that will continue throughout the study.
• People who have received an experimental treatment within 4 weeks (or within 5 half-lives of that treatment, whichever is longer) before joining the trial.
• People who have received a live vaccine within 30 days before joining the trial (non-live COVID-19 vaccines are permitted at any time).
• People who have been diagnosed with or treated for another invasive cancer within the past 2 years, with some exceptions such as certain skin cancers, cervical cancer in situ, or DCIS that has been fully treated.
• People who have received radiation therapy covering more than 20% of the bone marrow within 2 weeks before joining, or any radiation therapy within 1 week before joining.

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