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 given written consent to participate.
• People diagnosed with bladder cancer (urothelial carcinoma making up more than 50% of the tumour) that has been staged as cT2-4N0M0 according to standard medical staging guidelines (confirm with trial site).
• People whose cancer requires definitive local treatment, has been treated with maximum TURBT (a procedure to remove bladder tumours) followed by a three-part treatment approach combining surgery, radiation, and chemotherapy (tri-modality therapy).
• People who achieved a complete response (no detectable cancer) after tri-modality therapy, assessed between 28 and 90 days after completing that treatment.
• People whose tumour was located on one side of the bladder wall only.
• People who have measurable disease according to standard imaging criteria (RECIST 1.1), including lesions in previously treated areas if those lesions have shown signs of progression.
• People with a general health and activity level rated at 0, 1, or 2 on a standard medical scale (ECOG performance status), meaning they are fully active to capable of some self-care (confirm with trial site).
• People whose heart, liver, kidneys, and other organs are functioning adequately before starting the study treatment.

Who may not be able to join:

• Women of childbearing potential who have a positive pregnancy test within 72 hours before starting the trial.
• People who have previously been treated with certain immunotherapy drugs that target PD-1, PD-L1, PD-L2, CTLA-4, OX-40, CD137, or similar immune system pathways.
• People whose cancer has spread to distant parts of the body, or whose disease is considered inoperable, including those with cancer that has spread to lymph nodes or has grown into nearby structures making surgery not possible.
• People who have received any systemic anti-cancer treatment, including experimental treatments, within the 4 weeks before joining the trial.
• People who have received radiotherapy within 2 weeks before starting the study treatment, or who have not yet recovered from radiation side effects, or who have had radiation-related lung inflammation.
• People who have received a live vaccine (such as measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, or typhoid) within 30 days before the first dose — noting that standard injected flu vaccines are generally allowed, but nasal spray flu vaccines are not.
• People currently participating in, or who have participated in, another clinical trial involving an experimental treatment or device within the 4 weeks before the first dose.
• People with a known immune system deficiency, or who are taking steroid medications at doses above 10 mg of prednisone (or equivalent) per day, or any other immune-suppressing medication within 7 days before the first dose.
• People who have another cancer that is currently active or has required treatment within the past 3 years — though people with certain skin cancers or non-invasive cancers that have been treated with curative intent may still be considered.
• People who have had a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.
• People with an active autoimmune disease that has required systemic medical treatment within the past 2 years — though people taking routine hormone replacement therapy (such as thyroid medication or insulin) are not excluded on this basis.
• People with a history of lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonitis.
• People with an active infection that requires systemic treatment.
• People with a known history of HIV infection.
• People with known active Hepatitis B or Hepatitis C infection.
• People with any medical condition, ongoing therapy, or abnormal test result that the treating doctor believes could interfere with the study results or with the person's ability to safely complete the trial.
• People with known psychiatric conditions or substance use disorders that would make it difficult to follow the trial's requirements.
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the study period and for 120 days after the last dose of treatment.
• People who have previously received a transplanted organ or tissue from another person.

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