Phase 2 Bladder 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 been confirmed by laboratory testing to have metastatic bladder cancer (Arm A) or another advanced solid tumour cancer (Arm B), AND whose tumour has a specific gene or protein change in MLL4 (KMT2D gene), UTX (KDM6A gene), or MTAP, detected by genetic sequencing or tissue testing.
• People who have at least one tumour that can be measured on a scan, such as a CT scan.
• People who have previously received chemotherapy before or after surgery, or as a systemic (whole-body) treatment.
• People whose cancer has continued to grow despite two prior treatment lines for advanced or metastatic disease, or who were unable to tolerate a standard second-line treatment for medical reasons.
• People who have not previously been treated with the chemotherapy drug pemetrexed (prior bladder treatments given directly into the bladder, or immunotherapy, are acceptable).
• People who are aged 18 or older.
• People who have a general physical functioning level rated 0, 1, or 2 on a standard medical scale (meaning they are able to carry out at least some daily activities, with or without some limitations).
• People whose blood counts, liver function, and kidney function meet the specific levels required by the trial (confirm with trial site for exact values).
• People who are able to take supplemental folic acid, vitamin B12, and steroids as directed, which are given alongside the study drug as standard practice.
• People who are able to swallow tablets or capsules and do not have conditions that would prevent the body from absorbing oral medication.
• People with a known history of HIV who have had an undetectable viral load for at least 6 months prior to enrolling (if this test was previously done as part of their care — this test is not specifically required for the trial).
• People with a known history of hepatitis B who have an undetectable viral load while on appropriate treatment, if applicable (if this test was previously done as part of their care — this test is not specifically required for the trial).
• People with a known history of hepatitis C who have been successfully treated and cured, or who are currently being treated and have an undetectable viral load (if this test was previously done as part of their care — this test is not specifically required for the trial).
• People who have had brain tumours treated previously, provided that follow-up brain imaging shows the brain tumours are not growing.
• People who are able to stop taking anti-inflammatory medications (NSAIDs) or high-dose aspirin (more than 1.3 g per day) for a short period around each treatment dose, as instructed by the study team.
• People who are able to understand and sign a consent form, and who are willing and able to follow the study schedule and requirements.
• People who are capable of becoming pregnant, and their partners who are capable of producing sperm, must agree to use reliable contraception from the time of signing consent, throughout the study, and for 180 days after completing treatment.
• People capable of becoming pregnant must have a negative pregnancy test before enrolling.

Who may not be able to join:

• People who have previously received chemotherapy that included pemetrexed.
• People who have had chemotherapy or radiotherapy within the last 21 days before the planned start of treatment (for palliative radiation, a 5-day gap is sufficient).
• People who still have side effects from previous cancer treatments that are rated above a mild level (with some exceptions, such as hair loss or nerve-related effects considered minor by the treating doctor).
• People who are currently taking part in another clinical trial using an investigational drug (a 21-day gap after stopping that drug is required before joining this trial).
• People who have had a serious allergic reaction to drugs that are chemically similar to pemetrexed.
• People who have an uncontrolled illness, such as an active infection requiring treatment through the bloodstream, heart failure with symptoms, unstable chest pain, or any other condition the treating doctor believes would make participation unsafe or interfere with the study.
• People who have or have had another cancer whose course or treatment could interfere with assessing the safety or effectiveness of the study drug.
• People with a history of heart disease or prior treatment with drugs known to affect the heart who are assessed as having heart function below a certain level on a standard medical classification scale (confirm with trial site for the exact threshold).
• People who have a significant build-up of excess fluid in the chest or abdomen that cannot be managed by draining.
• People who have had focal radiotherapy within 7 days, surgery under general anaesthetic within 7 days, surgery under local anaesthetic within 3 days, or palliative radiation within 5 days before the planned first dose.
• People who are pregnant or breastfeeding.

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