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 aged 18 to 84 years old.
• People who are able to understand and sign a consent form agreeing to take part in the study.
• People for whom the treating doctor determines that a single-drug treatment is the appropriate next step.
• People who have previously been treated with a drug called bevacizumab.
• People with a confirmed diagnosis of platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, where "platinum-resistant" means the cancer came back within 6 months of receiving certain chemotherapy drugs containing platinum.
• People who have at least one tumour spot that can be measured using standard imaging guidelines (called RECIST v1.1).
• People who have received at least one but no more than three prior rounds of cancer treatment, and whose cancer got worse during or shortly after their most recent treatment (specific rules apply depending on how many prior treatments were received — confirm with trial site).
• People with certain inherited or acquired gene mutations (BRCA1 or BRCA2) who have already received a type of treatment called a PARP inhibitor.
• People who have usable veins in both arms, or who are willing to have a temporary line placed for a blood collection procedure called apheresis.
• People who are able to sit or lie down with limited movement for around 6 hours during the apheresis procedure.
• People who have previously been tested for a protein called FRα; if that test was positive, the treating doctor must have offered treatment with a drug called mirvetuximab soravtansine-gynx before enrolment.
• People of childbearing potential who agree to use effective contraception during the study and for up to 7 months after treatment ends.
• People with a good general level of physical functioning, rated 0 or 1 on a standard scale (called ECOG performance status).
• People who have fully recovered from any major surgery at least 4 weeks before starting study treatment.
• People whose blood, liver, and kidney test results meet the minimum levels required by the study (confirm specific values with trial site).
• People with a previous or current other cancer whose history or treatment is not expected to interfere with this study.
• People with a known history of heart disease or past treatment with heart-affecting drugs, who are assessed as being in a satisfactory heart function category (Class 2B or better on the NYHA scale).
• People with an expected survival of more than 16 weeks.
• People who are willing and able to follow the study procedures and attend all required visits.

Who may not be able to join:

• People whose cancer is of a specific tumour type, including clear cell, mucinous, sarcomatous, mixed tumours containing those types, or low-grade or borderline ovarian tumours.
• People whose cancer has spread to areas outside the abdomen and pelvis, such as the brain, lungs, or bones.
• People who have received certain anti-cancer drugs or experimental treatments within 2 weeks before the cell infusion, or immunotherapy within 4 weeks before, or who have not yet recovered from side effects of those treatments (confirm timing details with trial site).
• People who currently have, or have a history of, a bowel obstruction, or who are considered at high risk of bowel obstruction.
• People who are unable to eat enough by mouth and require nutrition through a drip or are dependent on intravenous fluids.
• People who have or have had a build-up of fluid in the abdomen (ascites).
• People currently taking part in another clinical trial involving an experimental treatment.
• People who have received a transplanted solid organ (such as a kidney or liver).
• People with another cancer that is currently active or being treated, or who have had another cancer within the past 2 years (some exceptions apply for certain low-risk skin cancers or cancers that have been cured — confirm with trial site).
• People with a known severe allergic reaction to sulfa-containing medications used in this study.
• People with a known allergy to a substance called dimethyl sulfoxide (DMSO).
• People who previously had to permanently stop an immune therapy due to serious immune-related side effects, or who needed intensive or long-term immune-suppressing treatment to manage those side effects (an exception may apply for well-controlled hormone-related side effects — confirm with trial site).
• People with certain autoimmune conditions, including inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), rheumatoid arthritis, lupus, scleroderma, autoimmune vasculitis, or certain nerve conditions of autoimmune origin (people with Hashimoto's thyroid condition may still be eligible — confirm with trial site).
• People who have been taking high-dose steroid medication (more than 10 mg of prednisone or equivalent) for at least 4 weeks before the cell infusion (confirm timing with trial site).
• People with serious uncontrolled illnesses, including active infections, unstable heart conditions, uncontrolled heart rhythm problems, or mental health or social situations that would make it difficult to follow the study requirements.
• People who are HIV-positive.
• People with active, uncontrolled hepatitis B or C, known non-infectious lung inflammation, or any history of a lung condition called interstitial lung disease.
• People who have received a live vaccine within 30 days before starting study treatment (confirm timing with trial site).

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