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:

• Your bladder cancer has been confirmed by a tissue test (biopsy) and is at a specific stage — muscle-invasive, meaning it has grown into the bladder muscle, and has not spread widely to distant parts of the body (confirm specific staging details with trial site).
• Your cancer is mainly a type called "urothelial carcinoma," making up at least 50% of the tumor (note: certain rare subtypes, such as plasmacytoid or neuroendocrine, are not allowed).
• Your doctors have decided you are suitable for surgery to remove the bladder (radical cystectomy) along with nearby lymph nodes.
• You have tumor tissue available from a previous biopsy, or you are willing to have a new biopsy taken before starting the trial.
• You are generally well enough to carry out everyday activities with little or no limitation (based on a standard health scale scored 0–2).
• You have had a procedure to remove bladder tumor tissue through the urethra (a scope procedure) within roughly the last 60–74 days before joining the study.

Who may not be able to join:

• You already have significant nerve damage causing numbness, weakness, or pain (grade 2 or worse).
• Imaging has shown your cancer has spread to many lymph nodes or to other parts of the body.
• You have had poorly controlled diabetes in the last 3 months, based on a blood sugar test result (HbA1c of 8% or higher, or 7–8% with diabetes symptoms like excessive thirst or urination).
• You have been diagnosed with another cancer in the last 3 years, or still have signs of a previous cancer — though some exceptions apply, such as certain non-aggressive skin cancers, some prostate cancers under monitoring, or fully removed non-invasive cancers (confirm with trial site).
• You have an active eye condition involving the cornea (the clear front surface of the eye), such as a corneal ulcer (a mild surface condition being treated may be allowed — confirm with trial site).
• You have had lung inflammation (pneumonitis) or scarring lung disease in the past that needed steroid treatment, or you currently have this condition.
• You have a history of certain lung conditions, including idiopathic pulmonary fibrosis, organizing pneumonia, or drug-related lung inflammation, or signs of active lung inflammation on a recent chest scan.
• You have a weakened immune system, or you are currently taking high-dose steroid tablets or other medicines that suppress your immune system.
• You have an active autoimmune disease (where your immune system attacks your own body) that has needed medical treatment in the last 2 years — though some milder conditions such as vitiligo, stable hypothyroidism, or type 1 diabetes are allowed (confirm with trial site).
• You have previously been treated with certain immunotherapy drugs that work on the immune system's "checkpoint" pathway (such as PD-1 or PD-L1 inhibitors, or CTLA-4 targeted treatments).
• You have previously received chemotherapy or other systemic (whole-body) cancer treatments for bladder cancer, or any systemic cancer treatment including certain antibody-drug therapies within the last 3 years (note: some treatments placed directly into the bladder, such as BCG, are allowed — confirm with trial site).
• You have previously had surgery to partially remove your bladder for bladder cancer.
• You have previously had radiotherapy (radiation treatment) directed at the bladder.

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