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 locally advanced or metastatic bladder/urinary tract cancer (urothelial cancer) confirmed by a tissue sample, where the cancer cannot be removed by surgery or cured with radiation
• People whose cancer can be measured on scans according to a standard set of measurement rules (called RECIST 1.1), as assessed by the treating doctor
• People who have previously been treated with all three of the following: an immunotherapy drug that targets PD-1 or PD-L1, a platinum-based chemotherapy, and a drug called enfortumab vedotin (EV)
• People in China where a drug called disitamab vedotin (DV) may have been received instead of enfortumab vedotin before joining the trial
• People who have received no more than 2 previous treatment courses (lines of therapy) for their cancer
• People whose cancer has continued to grow or spread during or after their most recent treatment
• People who have a general health/activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity), assessed within 7 days before being assigned to a treatment group
• People whose treating doctor determines they are suitable to receive at least one of the following chemotherapy drugs: paclitaxel, docetaxel, or vinflunine
• People who are able to provide either a stored tumour tissue sample or a new tissue sample from a tumour that has not previously been treated with radiation
• People who are HIV-positive, provided their HIV is well managed with anti-HIV medication
• People who test positive for hepatitis B, provided they have been on hepatitis B antiviral treatment for at least 4 weeks and the virus is undetectable in their blood
• People with a history of hepatitis C, provided the virus is currently undetectable in their blood
• People who have adequate kidney, liver, blood, and other organ function (as assessed by the trial site)

Who may not be able to join:

• People with a history of serious dry eye disease, serious eyelid gland disease, or serious corneal conditions that affect how the eye heals
• People with serious, uncontrolled heart or blood vessel disease, or stroke-related conditions
• People who have had lung inflammation (not caused by infection) that required steroid treatment, or who currently have or are suspected to have lung inflammation that cannot be ruled out
• People who are HIV-positive and have a history of a cancer called Kaposi's sarcoma or a condition called Multicentric Castleman's Disease
• People who received cancer treatment within the past 4 weeks (or within 5 half-lives of the drug, whichever is shorter) and have not recovered from side effects of that treatment
• People who have previously been treated with a drug that targets a protein called TROP2 using a type of drug delivery system called an antibody-drug conjugate (ADC)
• People who have previously received an ADC that contains a type of chemotherapy called a topoisomerase 1 inhibitor
• People who completed standard radiation therapy within the past 6 weeks, or targeted (stereotactic) radiation within the past 4 weeks, or who still have side effects from radiation that require steroid treatment
• People who have received a live or live-attenuated vaccine within 30 days before the first dose of study treatment
• People who have previously received paclitaxel, docetaxel, or vinflunine as chemotherapy for their urothelial cancer
• People who have received an experimental drug or used an experimental medical device within the past 4 weeks
• People who have a condition affecting the immune system, or who are currently taking steroid medication or other immune-suppressing drugs on an ongoing basis within 7 days before the first dose
• People who have another cancer (separate from the urothelial cancer) that is currently growing or has required active treatment within the past 3 years
• People who have had cancer spread to the brain or spinal fluid (central nervous system metastases or carcinomatous meningitis), either currently or in the past
• People who have an active infection that requires ongoing treatment with systemic medication (beyond what the trial permits)
• People who have had a bone marrow, stem cell, or solid organ transplant at any point
• People who have not fully recovered from a major operation, or who are still experiencing complications from surgery

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