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:

• Adults aged 18 or older who have recently received a first confirmed diagnosis of muscle-invasive bladder cancer (a cancer that has grown into the muscle wall of the bladder), with the cancer being mainly of a type called urothelial, confirmed by a surgical procedure within the past 90 days. People with mixed cancer types may still be considered if at least half of the cancer is urothelial.
• People whose cancer has not spread to lymph nodes or other parts of the body, as confirmed by chest and abdominal/pelvic scans reviewed by the trial site.
• Male participants who agree to use contraception and not donate sperm during treatment and for at least 90 days after the last dose of one study drug (MK-3475) and 6 months after the last dose of the other study drug (ASG-22CE).
• Female participants who are not pregnant and not breastfeeding, and who either cannot become pregnant, or who agree to use contraception during treatment and for at least 120 days after the last dose of MK-3475 and 6 months after the last dose of ASG-22CE and radiation therapy.
• People who are willing and able to sign a written consent form to take part in the trial.
• People who are generally able to carry out daily activities with little or no limitation, as measured by a standard medical scale called the ECOG scale (scores 0 or 1), assessed within 7 days before the first dose.
• People whose heart, liver, kidneys, and other organs are functioning well enough, confirmed by blood tests taken within 10 days before the first dose.

Who may not be able to join:

• People who have widespread carcinoma in situ (a very early form of cancer) in four or more areas throughout the bladder.
• People who have had the same type of cancer (urothelial cancer) found anywhere outside the bladder in the past 2 years, unless it was in the upper urinary tract and was fully removed by surgery.
• People whose tumor sample contains any small cell or neuroendocrine cancer cells.
• People who have another cancer that is still growing or has needed active treatment within the past 3 years. Note: certain skin cancers, early-stage cervical or breast carcinoma in situ treated with curative intent, superficial bladder cancer, and low-risk prostate cancer (under specific medical criteria) are not excluded (confirm with trial site).
• People who have poor bladder function, such as only being able to pass very small amounts of urine (less than 30 mL), ongoing urinary incontinence, or who need to use a catheter regularly or permanently.
• People who have previously had radiation therapy to the pelvic area for any reason.
• People who have already received radiation therapy to the pelvis or any cancer treatment for muscle-invasive bladder cancer. Note: prior treatment for early-stage (non-muscle-invasive) bladder cancer using therapies placed directly into the bladder (such as BCG) is allowed if completed at least 28 days before the first trial dose, but prior systemic (whole-body) treatment for early-stage bladder cancer is not allowed.
• People who have previously been treated with certain types of immunotherapy drugs that target PD-1, PD-L1, PD-L2, or similar immune system pathways (such as anti-CTLA-4 treatments).
• People who have previously received the study drug ASG-22CE or any similar drug from the same class (MMAE-containing antibody-drug conjugates).
• People who have received a live or live-weakened vaccine within 30 days before the first dose. Inactivated (killed) vaccines are allowed.
• People who are currently taking part in another clinical trial using an experimental treatment, or who have done so within the past 3 months before the first dose. People who are in a follow-up phase of a previous trial may still be considered if it has been at least 4 weeks since their last dose of the experimental treatment.
• Women who could become pregnant and have a positive pregnancy test within 72 hours before the first dose.
• People with poorly controlled diabetes, defined as a blood sugar control measure (HbA1c) of 8% or above, or between 7% and 8% with significant diabetes symptoms such as excessive thirst or urination.
• People with ongoing moderate-to-severe nerve damage (numbness, tingling, or weakness, Grade 2 or higher).
• People with active inflammation or ulceration of the cornea (the clear surface of the eye). People with a mild and well-managed eye surface condition may still be considered (confirm with trial site).
• People who have had radiation therapy within 2 weeks before starting the trial, or who are still experiencing side effects from previous radiation that require steroid treatment. Note: a short course of palliative (symptom-relieving) radiation for non-brain conditions may be allowed with a one-week gap (confirm with trial site).
• People who have been diagnosed with an immune system deficiency, or who are taking steroid medication above a certain dose (more than 10 mg of prednisone or equivalent daily) or other immune-suppressing medicines within 7 days before the first dose.
• People who have had a severe allergic reaction (Grade 3 or higher) to either of the study drugs or their ingredients.
• People with an active autoimmune disease (where the immune system attacks the body) that has needed systemic medical treatment within the past 2 years. Hormone or other replacement therapies (such as thyroid hormone or insulin) are generally not excluded (confirm with trial site).
• People with a history of serious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment, or who currently have this condition.
• People with an active infection that requires treatment through the bloodstream or throughout the body.
• People with a known history of HIV infection, confirmed by a test within 28 days before the first dose.
• People with both active Hepatitis B and active Hepatitis C infections at the same time, confirmed by tests within 28 days before the first dose.
• People who have not fully recovered from a major surgical procedure or who have ongoing complications from surgery.
• People with any other medical condition, treatment history, or lab result that the treating doctor believes would make participation unsafe or interfere with the trial.
• People with known serious psychiatric conditions or substance use disorders that would prevent them from following the trial requirements.
• People who are pregnant or breastfeeding, or people (male or female) who wish to conceive a child from the time of screening until 120 days after the last dose of MK-3475 and 6 months after radiation therapy and the last dose of ASG-22CE, or their partners.
• People who have had an organ or tissue transplant from another person.
• People who have had a stroke, mini-stroke (transient ischemic attack), unstable chest pain, heart attack, or severe heart failure symptoms within the 6 months before the first dose.
• People who the trial doctor considers unsuitable for any other reason.

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