Phase 3 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 aged 18 to 75 years old, of any gender
• People who have been newly and definitively diagnosed with medium- or high-risk bladder cancer that has not grown into the muscle wall (specific stages T1, Ta, or Tis), confirmed by tissue examination, and for whom BCG bladder treatment has been recommended
• People who have had a procedure called TURBt (a surgical procedure to remove bladder tumours) where all visible tumours were fully removed — including those who required a second TURBt procedure under specific circumstances (confirm with trial site)
• People who have never previously received BCG bladder instillation treatment
• People with a general health/activity level rated at 0–2 on a standard medical scale (meaning able to carry out at least some daily activities)
• People whose recent blood test results meet specific thresholds for blood cell counts, liver function, kidney function, and blood clotting (confirm with trial site for exact values)
• People who are willing and able to understand the study procedures and provide written consent to participate

Who may not be able to join:

• People currently using immune-suppressing medications, certain hormones (except hormone replacement after thyroid or adrenal gland removal), or radiotherapy that could affect the body's response to BCG
• People with a known allergy to BCG or similar substances
• People with active tuberculosis (TB), currently receiving TB treatment, or who have received TB treatment in the 6 months before screening
• People where a bladder puncture or tear is known or suspected to have occurred during surgery
• People with severe visible blood in the urine before starting treatment, or where the surgical wound is suspected to not have healed properly
• People with an active bladder infection causing symptoms such as frequent urination, urgency, or pain severe enough to interfere with study assessments, or who have had other bladder instillation treatments with significant irritation symptoms
• People with a history of severe reactions to BCG, such as BCG-related blood infection or widespread infection
• People with complete bladder incontinence requiring six or more pads within a 24-hour period
• People who have another tumour of the urogenital system or another solid organ cancer at the same time
• People with a history of severe heart, lung, liver, or kidney disease, or diabetes or high blood pressure that cannot be adequately controlled
• People with evidence that their bladder cancer has spread into the muscle wall, spread beyond the bladder, or is present outside the bladder in the urinary tract
• People who have received chemotherapy, radiotherapy, or immunotherapy within 4 weeks before the first dose (not including immediate post-surgical bladder instillation)
• People who are pregnant or breastfeeding
• People who are unable or unwilling to use effective contraception throughout the study and for 6 months after the last dose
• People who have participated in another clinical drug trial within the 3 months before screening
• People with a known dependence on opioids or alcohol
• People with a positive test result for HIV, syphilis, active hepatitis B, or hepatitis C at levels above specified thresholds
• People with a cognitive impairment or history of poor ability to follow medical instructions
• People with any other condition or circumstance that the trial doctors judge could increase risk or affect how the study is carried out

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