Phase 2 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 who have been diagnosed with suspected advanced-stage ovarian cancer that has not yet been treated, and who are planned to have a keyhole surgery (laparoscopy) to confirm the diagnosis and plan treatment
• People who are willing and able to follow the study schedule, including attending all planned visits and examinations throughout the study
• People who are willing to provide tissue samples collected during keyhole surgery and during their main surgery, as well as repeated blood samples for research purposes
• People who are willing to provide tissue samples preserved in a standard laboratory way (FFPE) from both surgeries
• People aged 18 or older
• People who are able to understand and sign a consent form agreeing to take part, including all study requirements
• People who have signed and dated consent forms for both the biomarker/genetic research part and the treatment part of the study, before any study procedures begin
• People who have a good general level of physical functioning (rated 0 or 1 on a standard scale used by doctors to measure how well a person can carry out daily activities) (confirm with trial site)
• People who are expected to live for at least 16 weeks
• People who are able to swallow tablets or capsules
• People who are postmenopausal, or people of childbearing potential who have a negative pregnancy test within 28 days before starting treatment and again confirmed before the first dose — postmenopausal may be defined in several ways, including not having had a period for at least one year after stopping hormone treatments, having hormone levels in the postmenopausal range, having had ovaries removed by surgery, or having had menopause caused by chemotherapy or radiation (confirm with trial site for which definition applies)
• People of childbearing potential who agree to use two highly effective forms of contraception together from the time of signing the consent form, throughout treatment, and for at least 6 months after the last dose — or who agree to completely abstain from sexual intercourse during this time
• People whose cancer has been confirmed as advanced-stage (FIGO stage IIB, III, or IV) high-grade ovarian, fallopian tube, or primary peritoneal cancer of certain types (not mucinous or clear cell), or people with a known BRCA gene mutation regardless of cancer cell type (confirm with trial site)
• People who are planned to have primary debulking surgery (main surgery to remove the tumour) after the laparoscopy has confirmed the diagnosis
• People who weigh more than 30 kg
• People whose blood test results show that their organs and bone marrow are working within acceptable levels, tested within 28 days before starting treatment — including healthy red blood cells, white blood cells, platelets, liver, and kidney function (confirm with trial site for specific values)
• People who have successfully provided the required blood and tissue samples as part of the study

Who may not be able to join:

• People whose disease requires urgent surgery right away
• People with another serious uncontrolled medical condition that could make it difficult to follow the study requirements
• People with significant uncontrolled symptoms, such as a large amount of fluid in the abdomen, breathlessness during activity, pain requiring strong opioid pain relief, or signs of bowel blockage
• People with uncontrolled ongoing illness, including active infection, uncontrolled heart failure, a heart attack within the past 3 months, uncontrolled high blood pressure, unstable chest pain, abnormal heart rhythms, lung disease, uncontrolled seizures, unstable spinal cord compression, a condition called superior vena cava syndrome, serious bowel conditions causing ongoing diarrhoea, or mental health or personal circumstances that would make it very difficult to follow the study
• People who have had another type of cancer within the past 5 years, unless it was successfully treated with no signs of return — some exceptions apply, such as certain types of skin cancer, treated cervical cancer in situ, certain early-stage breast cancers, or early-stage womb cancer (confirm with trial site)
• People whose resting heart tracing (ECG) shows uncontrolled heart problems, such as unstable reduced blood flow to the heart, uncontrolled irregular heartbeat, heart failure, a specific measurement of the heart's electrical activity being too prolonged, or a condition called congenital long QT syndrome
• People who still have side effects of grade 2 or higher from previous cancer treatment, with some exceptions such as hair loss or skin colour changes (confirm with trial site)
• People who have or show signs of a blood disorder called myelodysplastic syndrome or acute myeloid leukaemia
• People with cancer that has spread to the brain or who have spinal cord compression
• People with cancer that has spread to the lining of the brain or spinal cord
• People considered at high medical risk due to serious uncontrolled illness, non-cancer-related disease, or active uncontrolled infection
• People who are unable to swallow tablets or capsules, or who have bowel conditions likely to prevent the study medication from being properly absorbed — including people on tube feeding or with short bowel syndrome
• People with a weakened immune system, including people known to be HIV positive
• People with a history of a primary immune deficiency disorder
• People with active tuberculosis, active hepatitis B, or active hepatitis C (some people with past resolved hepatitis B or negative hepatitis C RNA test results may still be eligible — confirm with trial site)
• People with a general health status rated 2 or above on the standard doctor's scale, or whose overall condition may make it difficult to follow the study
• People with a known allergy or sensitivity to any of the study drugs or their ingredients
• People who have previously received any treatment for ovarian, fallopian tube, or primary peritoneal cancer
• People who have received chemotherapy or radiotherapy (other than for pain relief) within 3 weeks before starting the study
• People who are currently receiving any other chemotherapy, experimental treatment, biological treatment, or hormonal cancer treatment at the same time — use of hormonal therapy for non-cancer reasons (such as menopause hormone therapy) is permitted
• People who are planned to receive chemotherapy before surgery (neoadjuvant chemotherapy), or whose cancer was found to be unable to be surgically removed at laparoscopy
• People taking certain medications that affect how the body processes the study drug olaparib — including some antifungals, antibiotics, and other medicines (confirm with trial site for the full list and required stop periods before joining)
• People taking certain other medications that can speed up the breakdown of olaparib in the body, including some epilepsy medications and St John's Wort (confirm with trial site for the full list and required stop periods)
• People who have had major surgery within 2 weeks before starting the study, or who have not fully recovered from recent major surgery
• People who have previously received an organ transplant from another person
• People who have previously had a bone marrow or cord blood transplant from another person
• People with a known allergy to the study drug olaparib or its ingredients
• People who have previously been treated with olaparib or any other PARP inhibitor drug
• People who have received a whole blood transfusion within the 120 days before joining the study (transfusions of packed red blood cells or platelets may be acceptable — confirm with trial site)
• People who are pregnant or breastfeeding, or people of reproductive potential who are not willing to use effective contraception from screening until 6 months after the last dose of study treatment
• People who are involved in planning or running this study
• People who have taken part in another clinical trial with an experimental treatment within the last 3 months
• People who are currently enrolled in another interventional clinical trial
• People who have previously been enrolled in this same study
• People whom the trial doctor believes are unlikely to be able to follow the study requirements

Additional criteria that apply only to people joining the group receiving durvalumab (Cohort B):

• People who received their last cancer treatment less than 28 days before starting the study (a longer wait may be needed in some cases — confirm with trial site)
• People still experiencing side effects of grade 2 or higher from previous cancer treatment, with some exceptions (confirm with trial site)
• People with active or previously documented autoimmune or inflammatory conditions such as inflammatory bowel disease, lupus, rheumatoid arthritis, sarcoidosis, and others — some exceptions apply, including stable thyroid conditions managed with hormone replacement, vitiligo, hair loss, certain skin conditions not needing systemic treatment, and bowel conditions managed by diet alone (confirm with trial site)
• People with a heart tracing (ECG) showing a specific measurement called QTcF of 470 ms or above, averaged across three readings
• People who have received a live vaccine within 30 days before starting the study
• People who have previously been enrolled in a clinical trial of durvalumab, regardless of which treatment group they were in
• People who have previously received certain immunotherapy drugs (anti-PD-1, anti-PD-L1, or anti-CTLA-4 treatments) and who had serious immune-related side effects, had those side effects lead to permanently stopping the immunotherapy, or who required additional immunosuppressive treatment beyond steroids (confirm with trial site for full details)
• People who have used immunosuppressive medications within 14 days before starting durvalumab, with some exceptions such as low-dose steroids, inhaled or topical steroids, or steroids used to prevent allergic reactions to scans
• People who are planned to receive chemotherapy before surgery
• People with signs of bowel blockage

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