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 muscle-invasive bladder cancer (a cancer that has grown into the muscle wall of the bladder), confirmed by a tissue biopsy, with the cancer mainly being of the urothelial type (the most common bladder cancer cell type), and staged at a specific level that has not spread to lymph nodes or other parts of the body
• People whose tissue sample from the bladder cancer has been sent in for clinical staging at the start of the trial
• People whose doctor considers them suitable to receive a combination of chemotherapy and radiation therapy, using one of the specific chemotherapy regimens outlined in the trial
• People who are well enough to receive systemic (whole-body) treatment and who have chosen to try to keep their bladder, including those who are not suitable for, or have decided against, surgical bladder removal
• People who have a general health and activity level rated as 0, 1, or 2 on a standard medical scale (meaning they are fully active, have some limitations but can care for themselves, or are up and about more than half of waking hours) (confirm with trial site)

Who may not be able to join:

• People whose cancer has spread to lymph nodes or other parts of the body, or whose cancer is not mainly of the urothelial type, or who have widespread or multiple areas of a certain type of early cancer (CIS) in the bladder, or who have had urothelial cancer in areas outside the bladder within the past 24 months (with a specific exception for certain upper urinary tract cases where the kidney was fully removed)
• People who have previously received any systemic (whole-body) treatment, combined chemotherapy and radiation, or radiation alone for their bladder cancer (either muscle-invasive or non-muscle-invasive)
• People who have previously had radiation therapy to the pelvic area for any reason
• People who have poor or inadequate bladder function
• People who have had another active cancer within the 3 years before joining the trial
• People who have previously been treated with the drug enfortumab vedotin or similar types of drugs in the same class (MMAE-based antibody-drug conjugates)
• People who have previously been treated with a type of immunotherapy drug known as a PD-1 or PD-L1 inhibitor
• People with diabetes that is not well controlled
• People who are currently receiving antibiotic, antiviral, or antifungal treatment for an active infection at the time of joining the trial (routine preventive use of these medicines is allowed)
• People with a currently active hepatitis B infection, active hepatitis C infection, or HIV
• People who have had major surgery (requiring general anaesthesia and more than 24 hours in hospital) within 4 weeks before joining the trial
• People with a known serious allergic reaction to any ingredient in enfortumab vedotin
• People with known genetic conditions that make the body's cells unusually sensitive to radiation (such as ataxia telangiectasia, Nijmegen breakage syndrome, or Fanconi syndrome)
• People with a current active eye condition involving inflammation or ulceration of the cornea (the clear front surface of the eye)
• People who have had an autoimmune disease (where the immune system attacks the body) that required ongoing medical treatment within the past 2 years
• People with a history of certain lung conditions, including idiopathic pulmonary fibrosis, organising pneumonia, drug-related lung inflammation, or idiopathic pneumonitis, or who show signs of active lung inflammation on a recent CT scan
• People who have previously received a donor stem cell transplant or a solid organ transplant (such as a kidney or liver transplant)
• People who have received a live attenuated vaccine (a type of vaccine made from a weakened form of a live virus or bacteria) within 30 days before joining the trial

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