Phase 2 Bladder Cancer Trial, Recruiting

Written by an AI model from the 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 18 years of age or older at the time of signing the consent form.
• People who are well enough to carry out daily activities with minimal to no limitation (as assessed using a standard medical scoring tool called the ECOG scale, with a score of 0, 1, or 2).
• People who have been diagnosed through laboratory testing with muscle-invasive urothelial cancer (a type of bladder or urinary tract cancer) that started in the bladder, ureter, or the part of the kidney where urine collects. Most subtypes are allowed, except small cell carcinoma.
• People who have already had surgery with the goal of curing the cancer (either removal of the bladder or removal of the kidney and ureter), performed within the 180 days before starting the study treatment.
• People who have no visible signs of cancer remaining on scans taken within 28 days of starting the study treatment.
• People who received platinum-based chemotherapy before surgery are allowed to join. People who did not receive chemotherapy before surgery may still be eligible if a doctor has determined they are not suitable for a specific chemotherapy drug called cisplatin, or if they declined that type of chemotherapy.
• People who received other investigational (experimental) treatments before surgery are allowed, except those who received certain immune checkpoint drugs (PD-1/PD-L1 inhibitors) or a drug called sacituzumab govitecan before surgery.
• People who received chemotherapy before surgery must have cancer that was found to be at a high-risk stage (pathologic T2, T3, T4, or spread to nearby lymph nodes) in the tissue removed during surgery.
• People who did not receive chemotherapy before surgery must have cancer that was found to be at a high-risk stage (pathologic T3, T4, or spread to nearby lymph nodes) in the tissue removed during surgery.
• People whose blood tests show that their bone marrow, liver, and kidneys are functioning at a sufficient level, including adequate white blood cell counts, platelet counts, liver function markers, kidney function, haemoglobin, albumin levels, and blood clotting markers (confirm specific values with trial site).
• People who are sexually active and able to have children must agree to use an approved form of contraception during treatment and for 6 months after the last dose of study treatment.
• Women who could potentially become pregnant must not be pregnant at the time of signing the consent form. Women who have had a permanent sterilisation procedure or who have been through menopause (no periods for at least 12 months, in a woman aged 45 or older, with no other medical explanation) are not considered to be at risk of pregnancy for the purposes of this criterion.
• People who have recovered from most side effects of any previous cancer treatment, with only mild or stable remaining effects (confirm with trial site).
• People who have any type of urinary catheter (such as a nephrostomy tube or Foley catheter) are allowed to join.
• People who are willing and able to give written informed consent. People of any gender, race, or ethnic background are eligible. Non-English speaking, hard of hearing, and illiterate individuals are also eligible.

Who may not be able to join:

• People who had only a partial removal of the bladder or partial removal of the kidney, rather than full removal.
• People who have previously received any type of adjuvant (post-surgery) chemotherapy or other adjuvant therapy, including experimental treatments, after surgical removal of the urinary tract cancer.
• People who have previously received immune checkpoint drugs (PD-1/PD-L1 inhibitors) or sacituzumab govitecan at any point before starting the study treatment.
• People who have previously had radiation therapy to treat their urinary tract cancer.
• People whose scans show that the cancer has spread to other parts of the body.
• People who are currently receiving, or planning to receive, any other experimental treatment at the same time as this trial.
• People with a history of active, known, or suspected autoimmune disease (a condition where the immune system attacks the body's own tissues).
• People who need to take high-dose steroid tablets or other immune-suppressing medications within 14 days before starting the study treatment. (Inhaled or skin-applied steroids may be allowed if there is no active autoimmune disease — confirm with trial site.)
• People with a history of certain lung conditions, including idiopathic pulmonary fibrosis, organising pneumonia, drug-induced lung inflammation, or unexplained lung inflammation, or those who show signs of active lung inflammation on a screening chest scan.
• People who have had a major operation within 28 days, or a minor operation within 14 days, before the first dose of study treatment, or whose surgical wounds have not fully healed.
• People who have had another active cancer in the past 3 years, with exceptions for certain treated skin cancers, low-grade prostate cancer being monitored without treatment, or cancer of the breast lining or cervix that has been fully treated (confirm with trial site).
• People whose blood test results show that their organs are not functioning at the required level.
• People with uncontrolled ongoing illnesses, including any of the following:
  • An active and uncontrolled bacterial, viral, or fungal infection within 7 days before starting treatment.
  • HIV infection with a detectable level of virus in the blood.
  • Hepatitis B or C infection with a detectable level of virus in the blood.
  • Severe liver scarring (Child-Pugh C cirrhosis).
  • Active tuberculosis.
  • Serious heart failure, unstable chest pain, or uncontrolled irregular heartbeat (classified at a severe level).
  • A stroke, mini-stroke (TIA), heart attack, or other serious blood vessel event within 90 days before the first dose.
  • Severe, uncontrolled bleeding within 14 days before the first dose.
  • Severe, uncontrolled diarrhoea within 14 days before the first dose.
  • A history of inflammatory bowel disease (such as ulcerative colitis or Crohn's disease) or any condition that significantly increases the risk of developing severe diarrhoea.
  • Mental health or personal circumstances that would make it difficult to follow the study procedures or attend follow-up appointments.
• People who are pregnant at the time of, or after, signing the consent form.
• People who are breastfeeding at the time of, or after, signing the consent form.
• People who have received a live vaccine within 28 days before the first dose of study treatment.
• People with a known or suspected serious allergic reaction (severe hypersensitivity) to nivolumab, sacituzumab govitecan, irinotecan, or any of their ingredients.
• People whose overall health situation, other treatments, or test results may interfere with the study results or with their ability to safely complete the full study period, as determined by the trial doctor.

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