Phase 2 Bladder Cancer 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 who have been diagnosed with high-risk bladder cancer that has not grown into the muscle wall of the bladder, confirmed by a tissue sample.
• People who have a stored tissue sample available that was taken within the last 6 months before treatment is due to start.
• People whose bladder cancer is made up of more than 50% of a specific cell type called urothelial (transitional cell) carcinoma.
• People whose cancer has not responded to BCG treatment, or who are unable to tolerate BCG treatment.
• People who have declined bladder removal surgery, or whose doctor has determined that bladder removal surgery is not appropriate for them.
• People aged 18 or older.
• People who weigh more than 30 kg.
• People who are generally well enough to carry out everyday activities, with only minor limitations (as assessed using a standard medical scale called WHO performance status 0–1) (confirm with trial site).
• People who have had all of the following done within 8 weeks before joining: complete removal of all visible tumour growths with no sign of cancer in the muscle layer of the bladder wall; biopsy samples taken from multiple areas of the bladder; a CT scan of the chest; and either a CT urogram or MRI of the abdomen and pelvis.
• People whose blood counts and clotting results fall within the required ranges as measured by recent blood tests (confirm with trial site for specific values).
• People whose liver function test results fall within the required ranges (confirm with trial site for specific values).
• People whose kidneys are working well enough, based on a standard measurement of kidney filtering ability (creatinine clearance of at least 40 mL/min).
• People with a life expectancy of at least 6 months.
• People who are willing and able to give informed consent and follow the trial requirements.
• People who are able to become pregnant, and male participants whose partners are able to become pregnant, who agree to use highly effective contraception from the time of consent until at least 90 days after the last treatment dose.
• Female participants who are not pregnant, confirmed either by being post-menopausal or by a negative pregnancy blood test.
• People who are willing and able to attend scheduled visits, follow the treatment plan, and complete required tests and procedures.

Who may not be able to join:

• People with a history of autoimmune or inflammatory conditions, such as inflammatory bowel disease, lupus, sarcoidosis, rheumatoid arthritis, or similar conditions — though people with a past autoimmune condition that has not been active in the last 5 years may be considered after discussion with the trial team.
• People who have previously had a bone marrow transplant or received a donor organ transplant.
• People who have previously been treated with certain types of immunotherapy drugs that target specific proteins involved in immune response (anti-PD-1, PD-L1, or CTLA-4 treatments).
• People who have had another active invasive cancer in the past 2 years, not including certain common skin cancers.
• People with a history of lung scarring conditions, drug-related lung inflammation, or certain other lung conditions, or who show signs of active lung inflammation on a recent CT scan.
• People with a symptomatic lung condition that could make it harder to detect or manage lung side effects from the trial treatment.
• People with a specific heart rhythm abnormality (a prolonged QTc interval above 470 ms) detected on a heart tracing (ECG).
• People with certain risk factors for a serious bowel complication, such as a history of acute bowel inflammation or a blockage in the gut or cancer spread throughout the abdomen.
• People who still have unresolved significant side effects (grade 2 or higher) from previous cancer treatments, with some exceptions.
• People who received their last cancer treatment less than 30 days before the planned first dose of the trial treatment.
• People who have taken part in another experimental drug trial within 30 days, or within 5 half-lives of that drug (whichever is longer), before the first trial dose.
• People currently enrolled in another interventional clinical trial, unless that other trial is only observational or is in a follow-up phase only.
• People with severe or uncontrolled medical conditions or abnormal test results that the trial investigator believes make participation unsuitable.
• People who have recently taken oral antibiotics that cannot be stopped at least 14 days before starting treatment, or who have received antibiotic treatment through a drip (IV) within the last 14 days — though people taking preventative antibiotics (such as for urinary tract infection prevention) may still be eligible.
• People with a psychiatric condition or any other condition (such as brain metastases) that would affect their ability to consent to or follow the trial.
• People with a history of cancer spread to the membranes surrounding the brain and spinal cord.
• People with an active tuberculosis (TB) infection.
• People who have taken high-dose steroid tablets or similar medicines (above 10 mg prednisolone equivalent daily) within the 14 days before joining, or who are currently taking other medicines that suppress the immune system — though inhaled steroids and low-dose replacement steroids are permitted.
• People who have received a live vaccine within 4 weeks before the planned start of treatment, or who expect to need one during the trial.
• People with significant uncontrolled medical conditions such as severe liver disease, uncontrolled high blood pressure, serious ongoing gut conditions with diarrhoea, or uncontrolled seizures.
• People who have had major surgery within 28 days before the first trial dose — though bladder procedures such as rigid cystoscopy and biopsies do not count as major surgery for this purpose.
• People with significant heart conditions, including moderate-to-severe heart failure, a heart attack within the past 3 months, unstable abnormal heart rhythms, or unstable chest pain.
• People with uncontrolled Type 1 diabetes — though people whose diabetes is well managed on a stable insulin dose may still be eligible.
• People with uncontrolled adrenal gland insufficiency.
• People with an active hepatitis B or hepatitis C infection — though people with past resolved hepatitis B, or those who test positive for hepatitis C antibodies but have no detectable hepatitis C virus in the blood, may still be eligible.
• People with an active immune deficiency condition, including uncontrolled HIV or AIDS.
• Women who are pregnant or breastfeeding, or anyone of reproductive potential who is unwilling to use highly effective contraception from the screening period until 90 days after the last treatment dose.
• People with a known allergy or sensitivity to the trial drug or any of its ingredients.
• People who have previously taken part in a clinical trial involving the drug durvalumab, regardless of which treatment group they were in.
• Participants must not donate blood during the trial or for at least 90 days after the last dose of trial treatment.

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