Phase 2 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 diagnosed with bladder cancer (a specific type called urothelial carcinoma) at a certain stage (cT2-4a, meaning the cancer has grown into or through the bladder wall but has not spread to lymph nodes or other organs), who are planned to have their bladder surgically removed
• Mixed bladder cancer cell types are allowed, as long as some urothelial cancer cells are present — pure small cell or neuroendocrine (nerve-related) types are not included
• People whose treating doctor has determined they are not suitable for a standard chemotherapy drug called cisplatin, due to reasons such as reduced kidney function, moderate-to-severe nerve damage, moderate-to-severe hearing loss, moderate-to-severe heart failure, a combination of these factors, or personal choice not to receive cisplatin
• People aged 18 or older
• People with a good general level of physical functioning, able to carry out daily activities with little or no limitation (confirm with trial site for exact assessment)
• People whose blood counts, liver function, and kidney function meet certain minimum levels as measured by blood tests (confirm with trial site for exact values)
• People who are willing and able to use reliable contraception before, during, and for 3 months after the trial treatment — this applies to men and to women who could become pregnant
• People who are able to understand the study and are willing to sign a written consent form

Who may not be able to join:

• People who have previously received systemic (whole-body) treatment for bladder cancer, unless it was for an earlier, non-muscle-invasive stage of bladder cancer and was given more than 12 months before joining the trial — previous treatments placed directly into the bladder (such as BCG) are generally allowed; chemotherapy for a different cancer may be allowed if it was completed at least 1 year before joining (confirm with trial site)
• People who already have moderate or severe nerve damage affecting sensation or movement (neuropathy) at the time of joining
• People who are currently taking part in another clinical trial for the treatment of their bladder cancer
• People with a known history of serious allergic reactions to drugs that are chemically or biologically similar to the study treatment, enfortumab vedotin
• People with serious uncontrolled health conditions, such as an active infection, unstable heart problems, or significant mental health or personal circumstances that the trial doctor believes would make it difficult to safely participate
• People who are pregnant or breastfeeding

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