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 are 18 years of age or older
• You have been diagnosed with muscle-invasive bladder cancer (a specific type called urothelial cancer) that has not spread to lymph nodes or other parts of the body (stage T2-3N0M0), confirmed by a tissue sample; tumors with some mixed cell types may still qualify, but tumors with any neuroendocrine component do not (confirm with trial site)
• You have had a procedure to remove as much bladder tumor as possible (called a TURBT) within the last 90 days
• Tumor tissue from your TURBT procedure is available for the study to analyse
• Your doctor has determined you are healthy enough to undergo bladder removal surgery (radical cystectomy) with lymph node removal
• You are in good general health and able to carry out daily activities with little or no limitation (confirm with trial site)
• Your blood, kidney, and liver tests show your organs are working well enough, based on tests done within the last 28 days
• If you are a woman who could become pregnant, you have had a negative pregnancy test within the last 7 days and agree to use contraception
• If you are a man who could father a child and are sexually active with someone who could become pregnant, you agree to use effective contraception

Who may not be able to join:

• You have pre-existing nerve damage causing moderate or severe symptoms such as numbness, tingling, or weakness (Grade 2 or higher)
• You are still experiencing significant side effects (moderate or worse) from a previous cancer treatment, such as chemotherapy, radiation, or surgery
• You have previously received chemotherapy specifically for muscle-invasive bladder cancer
• You have had another cancer that was active within the last 2 years, unless it was a locally treatable cancer that appears to have been fully treated; some prostate cancer patients at lower risk may still be eligible (confirm with trial site)
• You have previously had radiation therapy to treat bladder cancer
• Your blood sugar control is poor, shown by a HbA1c (a blood sugar test) of 8% or above, or between 7–8% with diabetes symptoms such as excessive thirst or frequent urination
• You currently have an active infection that requires treatment with antibiotics or other systemic medication
• You have an active Hepatitis B or Hepatitis C infection (some people with past resolved infections may still be eligible — confirm with trial site)
• You have a known history of active tuberculosis (TB)
• You are currently pregnant or breastfeeding
• You have previously been treated with certain types of immunotherapy drugs that target the immune system's checkpoint pathways (such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or similar agents)
• You have received a live or live-attenuated vaccine (such as some flu or shingles vaccines) within the last 30 days
• You have been diagnosed with an immune system deficiency, or you are currently taking high-dose steroid medications or other drugs that suppress your immune system
• You have had a severe allergic reaction to pembrolizumab or enfortumab vedotin (the study drugs) or any of their ingredients
• You have an autoimmune disease (where your immune system attacks your own body) that has needed medical treatment within the last 2 years; hormone replacement therapies are generally still allowed (confirm with trial site)
• You have a history of serious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment, or you currently have this condition
• You have had an organ or tissue transplant from another person
• You are currently taking part in another clinical trial or have received an experimental treatment or used an experimental medical device within the last 28 days
• You have any other medical condition, ongoing therapy, or abnormal test result that the study doctor believes would make it unsafe or unsuitable for you to participate

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