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 are willing and able to sign a consent form and follow all study procedures for the full duration of the trial
• Women aged 18 years or older
• People who are in good enough general health to be active and able to care for themselves, with only minor limitations on physical activity (measured by a standard scale called ECOG Performance Status 0 or 1)
• People who have a confirmed diagnosis of a specific type of ovarian, primary peritoneal, or fallopian tube cancer (high-grade serous or endometrioid type)
• People whose cancer responded to or stayed stable after platinum-based chemotherapy, and whose cancer did not come back until more than 6 months after their last platinum treatment (not counting the most recent course)
• People whose cancer showed a complete response, partial response, or stable disease during their most recent platinum-based chemotherapy, as measured by standard imaging criteria (RECIST 1.1)
• People who have tissue samples available (stored tumour blocks or slides) that confirm their tumour has a medium or high level of a protein called folate receptor alpha (FRα)
• People who have received at least one prior platinum-based chemotherapy regimen for their cancer after it returned
• People whose most recent chemotherapy regimen was platinum-based and consisted of between 4 and 8 completed cycles
• People who have been tested for BRCA gene mutations, and if positive, have already received a type of treatment called a PARP inhibitor at some point
• People who start trial treatment within 8 weeks of their last dose of previous chemotherapy
• People whose blood counts, liver function, and kidney function meet specific healthy ranges as determined by blood tests (confirm with trial site for exact values)

Who may not be able to join:

• People whose ovarian tumour is of a specific type not covered by this trial, including clear cell, mucinous, sarcomatous, low-grade/borderline, germ cell, or sex-cord stromal types
• People whose cancer got worse during their most recent chemotherapy regimen (stable disease is acceptable)
• People who have received systemic chemotherapy or radiotherapy (other than for pain relief) within 3 weeks before starting the trial
• People with active or chronic eye conditions affecting the cornea, or ongoing eye problems such as uncontrolled glaucoma, certain forms of macular degeneration, active diabetic eye disease, or vision in only one eye
• People with a blood or bone marrow condition called myelodysplastic syndrome or acute myeloid leukaemia, or signs suggesting these conditions
• People with serious, uncontrolled medical conditions or active uncontrolled infections, including uncontrolled seizures, unstable spinal cord compression, certain psychiatric conditions, active hepatitis B or C, HIV, active cytomegalovirus infection, or a need for intravenous antibiotics within 2 weeks before starting treatment
• People with a history of multiple sclerosis or other nerve-damaging diseases, or Lambert-Eaton syndrome
• People with significant heart problems, including a heart attack within the past 6 months, uncontrolled irregular heartbeat, unstable chest pain, uncontrolled heart failure, severe uncontrolled high blood pressure, or a condition called superior vena cava syndrome
• People who have had a stroke or bleeding in the brain within the past 6 months
• People with advanced liver scarring (cirrhosis classified as Child-Pugh Class B or C)
• People with a history of non-infectious lung disease (such as interstitial lung disease or non-infectious pneumonitis), or extensive lung changes seen on a specialised scan (HRCT)
• People who still have significant side effects (above a moderate level) from previous cancer treatment, not including hair loss
• People who need to take folate supplements (for example, due to folate deficiency)
• People currently taking certain medications that strongly or moderately affect how the body processes drugs (specific enzyme inhibitors or inducers, including some antibiotics, antifungals, anticonvulsants, and herbal remedies such as St John's Wort) — a washout period may be required (confirm with trial site)
• People with a history of serious allergic reactions to monoclonal antibody treatments
• People who have previously received a bone marrow or cord blood transplant from a donor
• Women who are pregnant or breastfeeding, or who are unwilling to use highly effective contraception during the study and for at least 3 months after the last dose of one study drug (MIRV) and 6 months after the last dose of the other (Olaparib)
• People who have already been treated with MIRV or any other treatment that targets the folate receptor alpha (FRα) protein
• People with a stent in the small intestine (duodenum), or digestive conditions that would affect the absorption of tablets, including an inability to swallow oral medication
• People with untreated or symptomatic cancer spread to the brain or central nervous system
• People who have had another cancer diagnosis within the past 3 years (note: some low-risk skin cancers or cervical/breast carcinoma in situ may still be eligible — confirm with trial site)
• People with a known serious allergic reaction to any of the study drugs or their ingredients
• People who have had a surgical procedure within 2 weeks before starting treatment, or who have not fully recovered from a major operation
• People who are unable to comply with study procedures and follow-up visits
• People considered by the treating doctor to be otherwise unsuitable for the trial

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