Phase 2 Mesothelioma 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 aged 18 or older.
• People with a confirmed diagnosis of malignant peritoneal mesothelioma (a cancer affecting the lining of the abdomen) who have not yet received any treatment for it. Note: certain slow-growing subtypes (well-differentiated papillary mesothelioma and multicystic mesothelioma) are not eligible.
• People whose cancer can be measured on scans according to standard criteria (called RECIST v1.1).
• People who are in good enough general health to carry out light daily activities, as measured by a standard performance scale (ECOG score of 0 or 1).
• People whose blood cell counts, kidney function, and liver function meet minimum levels as determined by blood tests (confirm specific thresholds with the trial site).
• People whose urine protein levels are within acceptable limits on testing.
• People living with HIV who are on effective treatment and have had an undetectable viral load within the past 6 months.
• People with chronic hepatitis B who are on suppressive therapy and have an undetectable viral load.
• People who have previously had hepatitis C and were successfully treated and cured, or who are currently being treated for hepatitis C with an undetectable viral load.
• People with a history of autoimmune thyroid disease who are stable on thyroid hormone replacement therapy.
• People with well-controlled Type 1 diabetes managed with insulin.
• People with certain skin conditions (eczema, psoriasis, lichen simplex chronicus, or vitiligo affecting the skin only) may be eligible, provided the rash covers less than 10% of the body, is well controlled with only mild topical treatments, and has not required stronger treatments in the past 12 months.
• People who are not pregnant and not breastfeeding. Women of childbearing potential must have a negative pregnancy test within 28 days before registering for the trial.
• People of reproductive potential (both men and women) who agree to use an effective method of contraception throughout the trial, due to potential harm to a developing baby from the treatment used.
• People who received a live vaccine within 30 days of starting treatment may still be eligible at the doctor's discretion. Flu vaccines and COVID-19 vaccines are permitted.
• People who have had cancer spread to the brain (CNS metastases), provided it has been treated with local treatment (such as surgery or radiation) and any steroid medication has been reduced to a low maintenance dose.

Who may not be able to join:

• People who have already received systemic (whole-body) treatment for peritoneal mesothelioma, or who are currently receiving radiotherapy.
• People with a serious psychiatric condition that would prevent them from giving informed consent.
• People with serious uncontrolled medical conditions such as uncontrolled infection, uncontrolled diabetes, or significant heart disease that the treating doctor considers would make the trial too risky.
• People who are pregnant or breastfeeding.
• People with an active or past autoimmune disease or immune system disorder (such as lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, or similar conditions), with some exceptions listed above.
• People with a history of certain lung conditions, including idiopathic pulmonary fibrosis, organising pneumonia, drug-related lung inflammation, or active lung inflammation seen on a recent chest scan.
• People who have had an organ transplant or bone marrow/stem cell transplant from a donor.
• People with poorly controlled high blood pressure (above 150/100 mmHg), or a history of hypertensive crisis or related brain swelling.
• People who have had a stroke or heart attack within the past 12 months, unstable chest pain, significant heart failure, or a serious uncontrolled heart rhythm problem.
• People with significant blood vessel disease (such as a large aortic aneurysm or recent arterial blood clot) within the past 6 months.
• People with a history of a severe blood clot in a vein (grade 4 or above).
• People with a history of coughing up significant amounts of blood (2.5 mL or more per episode) within the past month.
• People with a known inherited bleeding disorder or significant clotting problems (unless already on anticoagulant treatment).
• People who have had major surgery or a serious injury within 28 days before starting treatment. (Diagnostic keyhole surgery to confirm the mesothelioma diagnosis is permitted.)
• People who have had a core biopsy or minor surgical procedure within 7 days before starting treatment (placement of a vascular access device is an exception, provided it is done at least 2 days before treatment starts).
• People currently on intravenous (IV) antibiotics for an active infection at the time treatment would begin.
• People with a history of bowel perforation, abdominal abscess, abdominal fistula, or active gastrointestinal bleeding within the past 6 months.
• People with a serious wound that has not healed, an active ulcer, or an untreated bone fracture.
• People who have had another cancer within the past 5 years, except for certain early-stage or localised skin cancers (such as basal or squamous cell skin cancer).
• People who are currently taking immunosuppressive medications (such as corticosteroids, methotrexate, or similar drugs) within 2 weeks before starting treatment, or who are expected to need these medications during the trial. Some exceptions apply (confirm details with the trial site).
• People with a kidney function level between certain values who use ibuprofen or similar anti-inflammatory painkillers around the time of a specific chemotherapy drug (pemetrexed) — the trial site can advise on this restriction.
• People with uncontrolled neurological conditions such as seizures unrelated to cancer, unless well managed with standard treatment.

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