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:

• You have been diagnosed with a specific type of early-stage bladder cancer (called T1 high-grade non-muscle invasive urothelial carcinoma) confirmed by a tissue biopsy, with no signs of cancer spread to nearby lymph nodes or other parts of the body on scans.
• Your doctors would normally recommend bladder removal surgery for your cancer, though you do not necessarily have to be healthy enough to have that surgery to qualify.
• Your cancer history must meet at least one of these conditions: (1) your cancer came back as T1 high-grade after an initial bladder scraping procedure (TURBT) and at least 5 doses of bladder treatment (such as BCG); OR (2) your initial biopsy showed high-risk features such as cancer spreading into blood or lymph vessels, or certain rare cell types (micropapillary, sarcomatoid, or plasmacytoid); OR (3) a second bladder scraping procedure still found T1 high-grade cancer.
• A second bladder scraping procedure (restaging TURBT) must have been done, with all visible tumors removed and muscle tissue present in the sample (confirm with trial site).
• You are 18 years of age or older.
• You are generally able to carry out basic daily activities (confirm with trial site what this means for your situation).
• If you could become pregnant, you must have a negative pregnancy test within 14 days before joining the trial.
• Your blood counts are at acceptable levels — including white blood cells, platelets, and red blood cells — based on recent lab tests.
• Your kidneys and liver are functioning at an acceptable level based on blood tests.
• Any side effects from your most recent treatment have mostly gone away or are at a manageable level.
• Your heart is functioning well enough (rated at a certain level on a standard heart health scale — confirm with trial site).

Who may not be able to join:

• Your cancer has spread to lymph nodes or other parts of the body.
• You have a type of bladder cancer that is purely squamous cell carcinoma or adenocarcinoma (different cell types than urothelial).
• Your cancer has certain features called neuroendocrine (small or large cell) features.
• You have widespread carcinoma in situ (a type of flat cancer) spread across the bladder lining, beyond what is directly associated with the tumor.
• Cancer has been found in the urethra near the prostate.
• You have previously received radiation therapy to the pelvis area.
• You have previously received systemic (whole-body) chemotherapy or immunotherapy for bladder cancer (note: prior local bladder treatments like BCG are allowed).
• You have previously received certain immunotherapy drugs that target the immune system's checkpoint proteins (such as anti-PD-1, anti-PD-L1, or anti-CTLA4 treatments).
• You received a live vaccine within 30 days before joining the trial.
• You have a serious heart condition rated at a certain level of severity (confirm with trial site).
• You currently have an active infection being treated with intravenous (IV) antibiotics.
• You have an active autoimmune disease that required medical treatment within the last 2 years (note: hormone replacement therapies are generally not counted as this type of treatment).
• You have a history of certain lung conditions, including pulmonary fibrosis or non-infectious lung inflammation that needed steroid treatment.
• You have had a bone marrow transplant from a donor or a solid organ transplant (such as a kidney or liver transplant).
• You currently have active tuberculosis.
• You have a blockage causing fluid buildup in the kidney (hydronephrosis).
• You had cancer in the upper urinary tract within the past 24 months.
• You have been diagnosed with prostate cancer but have not yet received treatment for it (for example, if you are on active surveillance).
• You are taking steroid medications (such as prednisone) at doses higher than a low, maintenance level.
• You have had an allergic reaction to the ingredients in the study drug.

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