Phase 2 Prostate 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 who have signed a consent form agreeing to take part in the trial before any trial procedures begin.
• People who are 18 years of age or older at the time of signing the consent form.
• People who live within 50 km of a hospital that can provide care during the trial.
• People who have been confirmed by laboratory testing to have either: stage IV colorectal cancer that cannot be cured by surgery, or locally advanced or metastatic prostate cancer that cannot be cured by surgery.
• People who have already received all standard treatments for their cancer type that are available through their national health insurance system and are recommended by medical guidelines — and those treatments either did not work well enough, were not medically appropriate, or were declined by the patient.
• People whose cancer has been confirmed by scans to have grown or spread since their last treatment.
• People who have enough suitable tumour tissue available that has not been previously treated with radiation — either from a planned surgery for another reason, or from a surgery the person has agreed to specifically for tissue collection, provided the surgical risk is considered acceptable by the doctor.
• People who still have at least one area of cancer that can be measured or assessed by scans after the surgery to collect tumour tissue.
• People who are in good general health, rated as fully active or able to carry out light work (confirm with trial site for exact definition).
• People who are expected to live for at least 6 months from the time of signing the consent form, in the opinion of the trial doctor.
• People whose blood counts, kidney function, liver function, and blood clotting levels meet the specific minimum standards required by the trial (confirm with trial site for exact values).
• People who are either past menopause or willing to use highly effective contraception for at least 6 months after the last dose of the trial treatment; male participants with fertile female partners must be willing to use condoms with spermicide, their partner must also use highly effective contraception for the same period, and male participants must not donate sperm during that time.
• People whose tumour tissue sample, collected during surgery, was successful and found to contain immune cells called TILs (tumour-infiltrating lymphocytes).
• People for whom the laboratory process of growing those immune cells into the trial treatment (CC-38) was successful.

Who may not be able to join:

• People with serious heart conditions, including severe heart failure, a heart attack or bypass surgery within the past 6 months, a history of significant heart rhythm problems or unexplained fainting, severe heart muscle disease, uncontrolled high blood pressure in the past 3 months, reduced heart pumping function below a certain level, a stroke or similar event within the past 6 months, or other heart conditions the treating doctor considers a health risk.
• People with certain breathing or lung conditions, including significantly reduced lung function, active chronic obstructive lung disease, a need for supplemental oxygen to maintain adequate blood oxygen levels, or other lung conditions that increase the risk of anaesthesia.
• People who have cancer that has spread to the brain or spinal cord, or who have a condition where cancer cells are present in the fluid around the brain or spinal cord.
• People with untreated or incompletely treated sores in the upper digestive tract, or enlarged veins in the oesophagus considered at high risk of bleeding.
• People who need ongoing blood-thinning medication or who have another condition that increases the risk of bleeding.
• People with any serious ongoing or long-term medical condition that the trial doctor believes puts them at increased risk or would make it harder to interpret the trial results.
• People with any form of primary immune system deficiency, such as severe combined immunodeficiency (SCID) or AIDS.
• People with active or past autoimmune or inflammatory conditions (though in some cases, the trial medical team may determine that certain individuals do not pose an increased risk — confirm with trial site).
• People currently taking immune-suppressing medications at a dose equivalent to 10 mg or more of prednisone per day (low-dose steroid replacements, topical steroids, or inhaled steroids may be permitted — confirm with trial site).
• People who have previously received an organ transplant or a stem cell transplant from a donor.
• People with a known active or ongoing hepatitis B or C infection.
• People with a known HIV infection.
• People with a known syphilis infection.
• People with a known condition where the bone marrow has stopped producing blood cells (bone marrow aplasia).
• People with a known long-term or current urinary tract infection, bladder damage from previous chemotherapy or radiation, or a blockage affecting urinary flow.
• People who are pregnant, breastfeeding, or planning to become pregnant within 12 months after receiving cyclophosphamide or within 6 months after the last dose of CC-38, whichever is later; people of childbearing potential must have a negative pregnancy test at the start of the trial and before each dose of CC-38.
• People who are unable to follow the trial procedures, restrictions, or requirements.
• People who received their most recent systemic cancer treatment (including anti-testosterone therapy) less than 4 weeks before enrolling in the trial.
• People who received palliative radiotherapy to an area containing measurable cancer lesions less than 4 weeks before enrolling.
• People who had a minor surgical procedure less than 3 weeks before enrolling.
• People who still have side effects from a previous treatment that have not returned to a mild level (confirm with trial site for exact grading criteria).
• People currently participating in another interventional clinical trial, or who have received an experimental treatment within 4 weeks before the start of screening.
• People whose cancer has spread only to the bones, with no other measurable disease sites.
• People with a known allergy or sensitivity to any component of the trial treatment regimen.
• People with colorectal cancer who have a specific genetic mutation known as BRAF-V600 positive.
• People with any medical reason that would prevent them from safely receiving the other medications used in this trial, including pembrolizumab, IL-2, cyclophosphamide, or uromitexan, based on current approved prescribing guidelines.

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