Phase 3 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 diagnosed with a specific type of bladder cancer called carcinoma in situ (CIS), with or without certain early-stage tumours (Ta or T1 high-grade disease), confirmed by medical records. For T1 disease, biopsy samples must show muscle fibres.
• People whose bladder cancer has not responded to at least 2 courses of BCG therapy (a type of bladder treatment given directly into the bladder) within the last 12 months, meeting specific criteria about the number of doses received and the timing of any cancer recurrence.
• People who have had all visible tumours surgically removed before starting the trial, and those with persistent T1 disease must have had a second surgical procedure (re-TURBT) between 14 and 70 days before starting trial treatment.
• People with a general health and activity level rated at 2 or below on a standard medical scale (ECOG), meaning they are able to care for themselves and are up and about for more than half of waking hours (confirm with trial site).
• People aged 18 or older at the time of giving consent.
• People who are able to participate for the full length of the trial.
• People expected to live more than 2 years, based on the doctor's assessment.
• People who have no cancer found in the upper urinary tract or in the part of the urethra that passes through the prostate, confirmed by appropriate imaging (such as CT scan or MRI) within the 6 months before joining.
• People who have chosen not to have their bladder removed (cystectomy).
• People with low-risk prostate cancer that is being monitored but not actively treated may be considered, at the doctor's discretion.
• Women who could become pregnant must have a negative pregnancy test before joining and must be willing to use highly effective contraception during treatment and for 6 months after the last dose; or must be post-menopausal (no period for at least 12 months, confirmed by a blood test) or have had a surgical procedure that prevents pregnancy.
• Men must be willing to use a condom and effective contraception during sex throughout the treatment period and for 3 months after the last dose.

Who may not be able to join:

• People who have or have previously had bladder cancer that has grown into the muscle wall of the bladder, or cancer that has spread to other parts of the body.
• People whose biopsy showed certain high-risk features, such as cancer cells spreading into blood or lymph vessels, or certain aggressive cell types (micropapillary, sarcomatoid, plasmacytoid, or neuroendocrine).
• People with CIS and T1 disease whose primary tumour is causing a blockage that has led to a swelling of the kidney (hydronephrosis).
• People currently receiving systemic (whole-body) treatment for bladder cancer, other than the treatment being tested in the trial.
• People who have received any experimental treatment for BCG-unresponsive bladder cancer, or any other experimental drug used in a clinical trial, within 1 month before the screening visit.
• People who have had radiation therapy to the pelvic area within 2 years before the screening visit.
• People who have previously received a specific treatment called nadofaragene firadenovec at any time.
• People who have ever previously received systemic (whole-body) treatment for bladder cancer.
• People who have previously received chemotherapy directly into the bladder for BCG-unresponsive bladder cancer.

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