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 of any gender, aged 18 or older.
• People diagnosed within the last 45 days with a specific type of early-stage bladder cancer (non-muscle-invasive bladder cancer, or NMIBC) that is low or high grade, confirmed by a pathologist and completely removed during surgery.
• People whose cancer is at stage Ta or T1 (meaning it has not spread into the deeper muscle of the bladder), with or without an associated type of surface cancer called carcinoma in situ (CIS).
• People with stage T1 disease who have had a scan (MRI or CT) within 90 days of joining that shows no signs the cancer has spread, and who have undergone a second surgical procedure (repeat TURBT) within 60 days of the first one and within 45 days of registering for the trial.
• People whose cancer is calculated to have a 50% or greater chance of returning within 2 years, based on a standard bladder cancer risk tool.
• People who are reasonably well and able to carry out daily activities (as measured by a standard scale called ECOG, scores 0–2).
• People whose blood, liver, and kidney test results fall within acceptable ranges as defined by the trial.
• Women who could become pregnant must have a negative pregnancy test and agree to use contraception for 120 days after the last dose of the study treatment (confirm with trial site for specific requirements).
• Women who cannot become pregnant — either due to surgical sterilisation (removal of the uterus, ovaries, or fallopian tubes), or no periods for at least 12 months confirmed by a hormone blood test.
• Male participants with a female partner who could become pregnant must agree to use contraception or abstain from sex, and must not donate sperm during treatment and for at least 120 days after the last dose.

Who may not be able to join:

• People whose bladder cancer has spread to the upper urinary tract or the part of the urethra that passes through the prostate, confirmed by imaging or biopsy within the past 12 months.
• People whose only diagnosis is carcinoma in situ (CIS) with no other bladder tumour present.
• People whose bladder cancer is purely squamous cell carcinoma or adenocarcinoma (specific cancer cell types different from the usual urothelial type).
• People whose cancer contains a feature called micropapillary components.
• People with a history of another cancer, with certain exceptions — including people with a returning NMIBC bladder tumour, treated skin cancers (basal or squamous cell), cervical cancer in situ, early-stage cancers now in full remission, any cancer from which a person has been cancer-free for five years, or people with low-risk prostate cancer on an active surveillance programme.
• People who have received BCG treatment (either into the bladder or into the skin) within the past 5 years, except for a BCG tuberculosis vaccination received in childhood.
• People regularly taking high-dose steroid medication (more than 10 mg of prednisone per day) at the time of joining the trial.
• People currently receiving or planning to receive other cancer treatments — including biologics, radiation, hormonal therapy, chemotherapy, or surgery — while on the study.
• People who have previously had combined chemotherapy and radiation treatment for bladder cancer.
• People currently receiving or scheduled to receive any chemotherapy agent (given by any method) during the study period.
• People currently taking part in any other clinical trial involving an experimental treatment.
• People with a weakened immune system, whether from birth, illness, medication, or other causes.
• People known to be HIV positive with a detectable level of virus in their blood.
• People currently diagnosed with AIDS.
• People with an active urinary tract infection (eligibility may be reconsidered once the infection has cleared, confirm with trial site).
• People with a physical injury to the bladder, or who have visible blood in their urine that has not resolved.
• People with a known allergy to substances similar in makeup to the BCG vaccine.
• People with a serious, uncontrolled medical condition.
• People with a psychiatric illness or personal circumstances that would make it difficult to follow the trial requirements.
• People who are pregnant or breastfeeding, as the study treatment may be harmful to an unborn baby or infant.

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