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 have been confirmed by tissue testing to have Stage III or Stage IV ovarian cancer (specific types including high-grade serous, endometrioid, carcinosarcoma, mixed Müllerian with high-grade serous component, clear cell, or low-grade serous), primary peritoneal cancer, or fallopian tube cancer.
• People whose doctors consider them suitable for carboplatin and paclitaxel chemotherapy given before planned surgery to remove tumours.
• People whose blood test results show a specific ratio of two cancer markers (CA-125 and CEA) of 25 or above — or, if the ratio is below 25, testing has ruled out other cancers such as breast or bowel cancer (confirm with trial site).
• People who are female and aged 18 or older at the time of signing the consent form.
• People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or restricted only in physically demanding activity), assessed within 7 days before joining.
• People who are not pregnant, not breastfeeding, and either cannot become pregnant, or agree to use reliable contraception during treatment and for at least 120 days after the last dose of pembrolizumab or olaparib, and at least 210 days after the last dose of chemotherapy.
• People who provide written agreement to take part in the study (a separate option exists to also consent to future research, but this is not required).
• People whose recent blood test results (taken within 7 days of joining) show that the kidneys, liver, blood cells, and clotting are all functioning within the acceptable ranges specified by the trial.

Who may not be able to join:

• People whose ovarian tumour type is mucinous, germ cell, or borderline.
• People who have had non-infection-related lung inflammation (pneumonitis) that needed steroid treatment, or who currently have pneumonitis.
• People who have a blood or bone marrow disorder called myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML), or who show signs suggestive of these conditions.
• People who have another cancer that is growing or has needed active treatment within the past 3 years — though certain skin cancers or pre-cancerous conditions that have been treated with curative intent may still be eligible (confirm with trial site).
• People with active cancer spread to the brain or the lining around the brain, unless the brain metastases were previously treated (not with chemotherapy), are stable on scans, cause no symptoms, and steroids have not been used to manage those symptoms in the 14 days before joining (confirm with trial site).
• People who have an immune system deficiency, are taking steroid medicines at doses above 10 mg of prednisone (or equivalent) daily, or are receiving other immune-suppressing treatments within 7 days before joining.
• People who have an autoimmune disease (where the immune system attacks the body) that has needed systemic medical treatment within the past 2 years — note that standard hormone replacement therapies are not considered systemic treatment.
• People with a known history of active tuberculosis (TB).
• People who currently have an active infection that requires systemic treatment (such as antibiotics given through a drip or tablets).
• People who are in poor overall health due to a serious uncontrolled medical condition or uncontrolled infection.
• People who had surgery to treat borderline ovarian tumours, early-stage ovarian cancer, or fallopian tube cancer less than 6 months before screening.
• People with a known psychiatric illness or substance use disorder that would make it difficult to follow the study requirements.
• People with a known history of HIV infection.
• People with known active hepatitis B or hepatitis C infection.
• People who have already received treatment for advanced or metastatic ovarian cancer, including radiation therapy or any systemic anti-cancer treatment such as chemotherapy, hormone therapy, immunotherapy, or investigational therapy.
• People who have had a severe allergic reaction (Grade 3 or above) to pembrolizumab, olaparib, carboplatin, paclitaxel, or any ingredient in these medicines.
• People whose heart tracing (ECG) at rest shows uncontrolled or potentially reversible heart problems, or who have a hereditary condition called congenital long QT syndrome.
• People who have received an organ transplant, a bone marrow transplant from another person, or a double umbilical cord blood transplant.
• People who have previously been treated with olaparib or any other PARP inhibitor medicine.
• People with a known allergy to any ingredient in olaparib.
• People who are currently taking certain medicines that strongly or moderately affect how the body processes olaparib (specific examples include itraconazole, clarithromycin, ciprofloxacin, fluconazole, and others), if those medicines cannot be stopped for the duration of the study (confirm with trial site for the full list).
• People currently taking certain medicines that reduce olaparib's effectiveness in the body (such as phenobarbital, phenytoin, rifampicin, St John's Wort, and others), if those medicines cannot be stopped for the duration of the study (confirm with trial site for the full list).
• People who received a whole blood transfusion within the 120 days before joining, or packed red blood cells or platelet transfusions within 28 days of the first study treatment dose, or certain blood-stimulating injections (such as G-CSF or erythropoietin) within 28 days of the first dose.
• People who are unable to swallow tablets or capsules, or who have a digestive condition that affects how medicines are absorbed (such as removal of the stomach, partial bowel blockage, or malabsorption).
• People considered to be at serious medical risk due to uncontrolled conditions such as severe heart rhythm problems, a heart attack within the past 3 months, uncontrolled seizures, unstable spinal cord compression, or serious lung disease on imaging.
• People with uncontrolled high blood pressure (above 140/90 mmHg on two separate readings at least one hour apart) — this applies specifically to those who would receive bevacizumab as part of the trial.
• People with a current clinically significant bowel blockage, abdominal fistula, or bowel perforation related to their cancer — this applies specifically to those who would receive bevacizumab.
• People with a history of significant bleeding, coughing up blood, or active gastrointestinal bleeding within 6 months before joining — this applies specifically to those who would receive bevacizumab.
• People who are currently taking part in, or have taken part in, another clinical trial involving an experimental treatment or device within 4 weeks of the planned first dose.
• People who the investigator believes are unlikely to be able to follow the study's procedures and requirements.

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