Phase 2 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 give voluntary written consent to participate
• People aged 18 to 75 years
• People with an expected survival of at least 12 weeks
• People with advanced ovarian cancer (Stage III or IV) confirmed by laboratory tissue analysis
• People whose tumour has tested negative for a genetic marker called HRD (homologous recombination deficiency), based on local testing
• People with at least one of these high-risk features: visible remaining disease after primary surgery for Stage III cancer; having received chemotherapy before surgery; or having Stage IV disease
• People with at least one tumour that can be measured on a scan, meeting specific size requirements (confirm with trial site)
• People whose tumour tissue shows a protein called HER2 (at levels 1+, 2+, or 3+), with tumour tissue available for central laboratory confirmation
• People with a good general level of physical functioning, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activities)
• People whose blood counts and organ function meet specific minimum levels, tested within 14 days before joining (without recent blood transfusions or certain blood-boosting treatments)
• People whose urine protein levels are within acceptable limits
• People with a heart that is functioning adequately, based on an ultrasound scan showing the heart pumping at least 50% efficiency and no severe heart failure symptoms
• Women who are either surgically unable to become pregnant, post-menopausal, or using an approved contraceptive method from screening until 6 months after the last dose; with a negative pregnancy test within 7 days of the first dose and not breastfeeding
• People who are able and willing to attend all required study visits and follow-up procedures

Who may not be able to join:

• People with certain less common subtypes of ovarian cancer that are not considered high-risk
• People with cancer that has spread to the brain or the lining around the brain
• People who need intravenous fluids or nutrition, or who have evidence of a bowel blockage or bowel perforation
• People with nerve damage in the hands or feet rated Grade 2 or higher on a standard medical scale
• People with active bleeding or conditions that create a high risk of serious bleeding
• People who had tumour-removal surgery fewer than 28 days before the planned first dose of bevacizumab (one of the study drugs)
• People who have had another cancer within the past 5 years, except for certain skin cancers or cervical cancer in situ that have been fully treated
• People who had major surgery within 4 weeks before the first study dose and have not fully recovered
• People with large fluid build-up in the chest or abdomen that is causing symptoms or requiring medical treatment
• People who have received a live vaccine within 30 days before the first dose, or who plan to receive one during the study
• People who had a serious blood clot, stroke, heart attack, or similar event within the 12 months before screening (some minor exceptions may apply — confirm with trial site)
• People with uncontrolled ongoing conditions such as diabetes, advanced liver disease, lung inflammation, or severe chronic lung disease
• People with certain heart and blood vessel problems, including uncontrolled high blood pressure, certain abnormal heart rhythms, a recent heart attack or unstable angina, moderate-to-severe heart failure, or a stroke within 6 months (confirm with trial site for full details)
• People who had a serious infection requiring intravenous antibiotics or antifungal or antiviral medicines within 4 weeks before the first dose, or who have an unexplained fever above 38.5°C during screening
• People with active autoimmune diseases or immune system disorders (some stable conditions such as well-controlled thyroid disease or type 1 diabetes may be exceptions — confirm with trial site)
• People who have required systemic medicines to suppress the immune system for an autoimmune condition within the past 2 years (certain stable replacement therapies may be exceptions — confirm with trial site)
• People with active or poorly controlled infections, including HIV, active hepatitis B, active hepatitis C, active tuberculosis, or other uncontrolled infections above a certain severity level
• People currently participating in another clinical trial or who have received an experimental treatment within 4 weeks before the first dose
• People with a known allergy or intolerance to the study drugs or their ingredients
• People with a history of substance use that cannot be managed, or a psychiatric condition that may affect their ability to follow the study requirements
• People with any other condition that the trial doctor considers would make participation unsafe

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