Phase 4 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:

• People who are able to understand the study and are willing to sign a consent form before any study-related procedures begin.
• People aged 18 or older.
• People who have a confirmed diagnosis of urothelial cancer (a type of cancer that affects the lining of the bladder and urinary tract), confirmed by tissue or cell testing.
• People who have tumour tissue available for the trial team to analyse.
• People whose cancer can be measured on scans, using a standard set of medical guidelines (called RECIST v1.1).
• People whose general health and ability to carry out daily activities meets a certain level, assessed using a standard scale called the ECOG performance status (score of 2 or lower). People with a score of 2 must also meet additional requirements around blood count, kidney function, and heart health (confirm with trial site).
• People expected to live for at least 6 months.
• People whose treating doctor considers them suitable for standard chemotherapy using cisplatin or carboplatin combined with gemcitabine.
• People who agree to use reliable contraception from the time of signing the consent form until 180 days after the last chemotherapy dose and 30 days after the last dose of avelumab (one of the study drugs). This applies to both women who could become pregnant and to men.
• People whose bone marrow, liver, and kidney are functioning well enough, confirmed by blood tests done within 7 days of starting treatment. Specific requirements include:
  • Kidney function above a certain level (creatinine below 2.5 mg/dL and clearance above 30 mL/min).
  • Liver enzyme and bilirubin levels within acceptable ranges.
  • Blood clotting measures within acceptable ranges (people on blood thinners such as warfarin or heparin may still be eligible if there is no underlying clotting problem, but will need close monitoring — confirm with trial site).
  • Adequate levels of platelets, red blood cells, and white blood cells.

Who may not be able to join:

• People who have previously received treatment for advanced or metastatic urothelial cancer.
• People who received additional cancer treatment after surgery (adjuvant therapy) within 1 year of being diagnosed with metastatic disease.
• People who have previously been treated with immunotherapy.
• People who have had a different cancer within the past 3 years, with some exceptions: certain early-stage or curable cancers may still be allowed, including treated cervical cancer in situ, non-melanoma skin cancer, certain early-stage bladder tumours, or early prostate cancer with very low PSA levels (confirm with trial site).
• People who have had a major surgical procedure, open biopsy, or serious injury within 28 days before starting the study.
• People who are pregnant or breastfeeding. Women who could become pregnant must have a negative pregnancy test within 7 days before starting treatment.
• People with certain heart conditions, including:
  • Moderate to severe heart failure (NYHA class 3 or worse).
  • Unstable chest pain at rest, newly developed chest pain (within the last 3 months), or a heart attack within the past 6 months.
  • Irregular heart rhythms that require specific medications to control (note: beta-blockers and digoxin are permitted).
  • High blood pressure that cannot be controlled with medication.
  • A stroke, mini-stroke (TIA), or blood clot in the lungs within the past 4 months.
• People with an active infection that is above a moderate level of severity.
• People with a known history of HIV, or chronic hepatitis B or C.
• People with an autoimmune disease that would prevent the use of immunotherapy as a maintenance treatment.
• People with a seizure disorder that requires ongoing medication.
• People with brain or spinal cord tumours that are causing symptoms, unless certain conditions are met (confirm with trial site).
• People who have previously received an organ transplant.
• People with a history of bleeding disorders, or a serious bleeding event within 4 weeks before starting the study.
• People with a wound, ulcer, or bone fracture that is not healing.
• People who require dialysis due to kidney failure.
• People with any unstable medical condition that could put them at risk or affect their ability to take part safely.
• People who have received a live or live-attenuated vaccine within 30 days before the first dose of the study drug (non-live vaccines are permitted).
• People who are currently taking part in another clinical trial.

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