Phase 1 Mesothelioma 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 diagnosed with a specific type of mesothelioma (a cancer affecting the lining of the lung) called epithelioid MPM, confirmed by laboratory testing of tissue samples, and who are eligible to receive 2 to 4 cycles of platinum-based chemotherapy.
• People who are at least 18 years old and are able to give written consent to participate.
• People whose cancer has not spread beyond certain defined boundaries — specifically, it must be at a stage where surgery is considered possible (stages I to IIIA), confirmed by a specialised PET-CT scan showing no spread to distant areas or certain lymph nodes. Small, isolated areas of chest wall involvement are acceptable.
• People for whom a tumour tissue sample is available after completing chemotherapy and before starting the experimental treatment — collected either by needle biopsy guided by CT scan, or by a keyhole surgical procedure.
• People who are considered fit enough by their surgeon and chest doctor to receive platinum-based chemotherapy and to undergo a type of lung surgery called pleurectomy/decortication (P/D), which may also include removal of part of the diaphragm or the lining around the heart.
• People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity).
• People who are able to return to the study centre for follow-up visits and vaccinations as required by the trial.
• People who show a positive reaction to a standard skin test (called a delayed-type hypersensitivity test), meaning a small raised area of more than 2mm appears 48 hours after exposure to at least one test substance (tetanus toxoid).
• People whose kidneys, liver, and blood counts meet certain minimum levels of function at the screening stage (confirm specific values with the trial site).
• Women who could become pregnant must have a negative pregnancy test at the start of the trial and again before the first study treatment, and must be willing to use an effective form of contraception during the trial and for at least 12 months after the last study treatment.
• Men must be willing to use effective contraception during the trial and for at least 12 months after the last study treatment.

Who may not be able to join:

• People whose cancer has grown into major structures in the chest such as the heart, main blood vessels, spine, or food pipe, or has spread widely through the chest wall (stage T4), to certain lymph nodes (N2), or to other parts of the body (stage IV/metastatic disease).
• People whose mesothelioma is not of the epithelioid type, as confirmed at the time of original diagnosis.
• People for whom a tumour tissue sample cannot be obtained after chemotherapy and before the experimental treatment begins.
• People with any other ongoing medical, psychological, or psychiatric condition that could affect their ability to consent, follow study procedures, or that the investigating doctor considers would make participation unsafe.
• People who have been taking more than 10mg per day of prednisolone (or an equivalent steroid or immune-suppressing medication) in the 6 weeks before the first study treatment — although steroid use during chemotherapy to manage side effects, and low-dose or inhaled/topical steroids, may be acceptable (confirm with trial site).
• People who have had a major surgical procedure or serious injury within 28 days before joining the trial, or who are expected to need major surgery (other than the planned mesothelioma surgery) during the trial.
• People with a history of another cancer, unless it was a type of skin cancer that has been fully treated, a very early-stage bladder cancer, or another cancer from which the person has been cancer-free for at least 3 years.
• People who have previously received any treatment for mesothelioma, including preventive radiotherapy to biopsy sites.
• People with a significant build-up of fluid around the lung that cannot be managed by draining or a procedure to seal the lung lining (confirm with trial site).
• People with a known active serious infection, including HIV, hepatitis B, hepatitis C, or syphilis.
• People with a history of autoimmune disease — although some conditions such as type 1 diabetes may be considered on a case-by-case basis following discussion with the medical team overseeing the trial.
• People who have previously received an organ transplant.
• People with serious ongoing or acute illness affecting the lungs (such as COPD or asthma), heart (rated class III or IV on a standard heart function scale), liver, or another condition the study team considers to carry too high a risk for the planned surgery or experimental treatment.
• Women who are pregnant, breastfeeding, or of childbearing potential who are unwilling to use effective contraception during the trial and for at least 12 months after the last study treatment.
• Men who are unwilling to use effective contraception for the duration of the trial and for at least 12 months after the last study treatment.
• People who do not have adequate vein access in the arm to allow a blood cell collection procedure called leukapheresis.
• People who have taken part in another clinical trial involving an experimental treatment within 28 days of joining this trial.
• People who are unlikely to be able to follow the study requirements or attend follow-up appointments.
• People with a known allergy to shellfish, as one of the study substances may contain a compound derived from shellfish (KLH).

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