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 who have been diagnosed with muscle-invasive bladder cancer (stages cT2, T3, or T4a) confirmed by a biopsy, with a tissue sample available for testing.
• People whose tumor contains urothelial cells (the most common bladder cancer cell type); mixed cell types are allowed as long as some urothelial cells are present, but at least some urothelial component must be confirmed.
• People whose doctor has determined that bladder removal surgery is either not suitable for them, or who have chosen not to have that surgery.
• People whose doctor has determined that radiation therapy to the bladder is appropriate and who agree to receive it.
• People who have had a procedure to remove bladder tumor tissue (called a TURBT) within 8 weeks before starting treatment, where living tumor cells were found in the sample.
• People aged 18 years or older.
• People who are generally well enough to carry out daily activities with no more than minor limitations, as measured by a standard medical scale (ECOG score of 0 or 1).
• People whose blood test results show healthy levels of white blood cells, platelets, and red blood cells, without having needed a blood transfusion in the past 2 weeks.
• People whose liver function blood tests are within acceptable ranges.
• People whose kidneys are functioning at a sufficient level (confirm specific threshold with trial site).
• People whose blood clotting tests are within acceptable ranges, including those on blood-thinning medication if their levels are within the intended treatment range.
• People living with HIV who are on effective treatment and have had an undetectable viral load within the past 6 months.
• People with a history of hepatitis B who have been on anti-viral treatment for at least 4 weeks and have an undetectable viral load before joining the trial.
• People with a history of hepatitis C who have completed curative anti-viral treatment at least 4 weeks before starting the trial and have an undetectable viral load.
• People with autoimmune conditions may be considered on a case-by-case basis, provided they are not taking immune-suppressing medication above a certain steroid dose threshold (confirm with trial site).
• Women who could become pregnant and men whose partners could become pregnant must agree to use reliable contraception during the trial and for a set period after the last dose (120 days for the main study drug; 8 weeks after the last dose for men generally) — the trial site will provide full details.

Who may not be able to join:

• People whose cancer has spread to distant parts of the body (metastatic disease).
• People whose cancer has spread to multiple nearby lymph nodes (N2 disease or higher on imaging).
• People whose tumor contains any small cell or neuroendocrine cancer cells.
• People whose tumor contains no urothelial cells at all (pure non-urothelial variant).
• People with untreated cancer in the upper urinary tract (the tubes connecting kidneys to the bladder).
• People with severe blockage of the kidneys (hydronephrosis) that the treating doctor determines would prevent treatment.
• People with extensive carcinoma in situ (a type of early-stage cancer spread) that the treating doctor determines would not benefit from radiation.
• People who already have nerve damage or nerve-related symptoms at a moderate or severe level (grade 2 or higher) before starting the trial.
• People with poorly controlled diabetes (confirm specific blood sugar thresholds with trial site); people with diabetes that is well managed may still be considered.
• People who have previously received immunotherapy or chemotherapy for bladder cancer, unless that treatment was completed more than 12 months ago. (Prior BCG therapy or treatments placed directly into the bladder are allowed.)
• People who have received any systemic anti-cancer treatment within 4 weeks before starting the trial.
• People who have received radiation therapy within 2 weeks before starting the trial, or who experienced side effects from radiation requiring steroid treatment.
• People who have received a live or live-weakened vaccine within 30 days before the first dose (certain COVID-19 vaccines are permitted — confirm with trial site).
• People who have had major surgery within 2 weeks before the first dose (minor procedures such as cataract surgery or standard biopsies are generally allowed).
• People who have an immune deficiency diagnosis or who are taking immune-suppressing medication above a certain steroid dose threshold within 7 days before starting (inhaled or skin-applied steroids are allowed).
• People living with HIV who also have a history of Kaposi's sarcoma or Multicentric Castleman's Disease.
• People with active cancer that has spread to the brain or spinal fluid.
• People who have had another serious cancer requiring systemic treatment within the past 2 years, or who still show signs of a previously diagnosed cancer (some exceptions apply — confirm with trial site).
• People with a known allergy or sensitivity to either of the study drugs (pembrolizumab or enfortumab vedotin) or their ingredients.
• People who have had a stem cell transplant or solid organ transplant from a donor.
• People with a history of, or current, non-infectious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment.
• People with an active infection currently requiring treatment.
• People who are pregnant or breastfeeding, as the study drugs may be harmful to a developing baby or nursing infant.
• People with known psychiatric conditions or substance use disorders that would make it difficult to participate in the trial requirements.
• People with any other condition, health history, or circumstance that the treating doctor believes would make participation unsafe or unsuitable.

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