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:

• People who are willing and able to sign a written consent form for the trial.
• People who are 18 years of age or older at the time of signing the consent form.
• People who wish to keep their bladder (rather than have it removed), or who have been assessed as not suitable for bladder removal surgery.
• People who have had a biopsy of their bladder tumour within 35 days before planned treatment starts, and where the laboratory results have confirmed a specific type of bladder cancer (urothelial cell carcinoma) that has grown into the muscle wall of the bladder, with limited spread to nearby lymph nodes and no distant spread.
• People who have had as much of the bladder tumour removed through keyhole-style bladder surgery as the surgeon judged safe, within 35 days before planned treatment starts.
• People whose bladder cancer is mainly urothelial cell carcinoma (more than 50% of the tumour type), even if some other cancer cell types are also present.
• People whose planned main treatment is a combination of chemotherapy and radiotherapy together.
• People who are in good general health, rated 0 or 1 on a standard health performance scale used by doctors (confirm with trial site).
• People whose bladder can be examined using a camera scope for follow-up monitoring.
• People whose organ function (such as kidney, liver, and blood) meets the required levels, based on tests done within 28 days of enrolling.
• Women who could become pregnant and who test negative for pregnancy within 72 hours before enrolling in the trial.
• Women who could become pregnant and who are willing to use one highly effective form of contraception, or who are surgically sterile, or who abstain from heterosexual activity for the duration of the study and for 5 months after the last dose of study medication.
• Male participants who are willing to use condoms from the first dose of study treatment through to 7 months after the last dose.
• People who are willing to allow their collected tumour, blood, and urine samples to be used for future scientific research, including testing for biological markers.

Who may not be able to join:

• People who have a condition called DPD deficiency, which affects how certain medicines are broken down in the body.
• People who have urothelial cell cancer occurring at the same time in other parts of the urinary tract (such as the urethra, ureter, or kidney), with some exceptions that the trial site can confirm.
• People who have extensive or widespread non-invasive cancer lining large areas of the bladder (called carcinoma in situ or CIS) that would prevent effective chemoradiotherapy.
• People who have cancer that has spread to distant parts of the body, based on a scan done within 28 days before joining (up to 3 affected lymph nodes in the lower pelvis may be allowed if they can be included in the radiotherapy area — confirm with trial site).
• People who have previously had lymph node removal surgery in the pelvic area.
• People who have previously had radiotherapy to the pelvic area.
• People who have previously received intravenous chemotherapy, targeted drug therapy, or radiotherapy specifically for bladder cancer (prior bladder-wash treatments with BCG or MMC are allowed).
• People who have existing medical conditions that make them unsuitable for the specific chemotherapy and radiotherapy combination used in this trial.
• People who are currently taking part in another clinical trial involving an experimental treatment, or who have done so within 4 weeks before the first dose.
• People who have been diagnosed with an immune system deficiency, or who are taking steroid medicines above a certain dose, or other immune-suppressing medications within 14 days before enrolling (people taking low replacement-level steroids for adrenal insufficiency may be allowed — confirm with trial site).
• People with a known history of active tuberculosis (TB).
• People who have a known allergy or sensitivity to nivolumab, ipilimumab, or any of their ingredients.
• People who have had another type of cancer at any point, unless they have been free of that cancer for 5 years. Some exceptions apply for certain low-risk skin cancers, early-stage cervical cancer, and a specific low-risk form of early prostate cancer in men — confirm with trial site.
• People who have any history of active autoimmune disease, Stevens-Johnson syndrome, or Guillain-Barré syndrome, with some exceptions for people with stable thyroid conditions or well-controlled Type 1 diabetes — confirm with trial site.
• People who have a known history of, or current signs of, a non-infectious lung inflammation condition (pneumonitis).
• People who currently have an active infection that requires treatment with systemic medicines (such as antibiotics given by mouth or through a drip).
• People who have a medical condition, ongoing treatment, or abnormal test result that could interfere with the trial results or their ability to complete the trial, as assessed by the treating doctor.
• People who have known psychiatric conditions or substance use disorders that would make it difficult to follow the trial requirements.
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the trial period and up to 120 days after the last dose of trial treatment.
• People who have previously received a type of immunotherapy drug known as an anti-PD-1, anti-PD-L1, or anti-PD-L2 treatment.
• People who have HIV infection with a detectable level of virus in their blood.
• People who have active Hepatitis B or Hepatitis C infection, confirmed by blood tests.
• People who have received a live vaccine within 30 days before the planned start of treatment (some standard inactivated flu injections are allowed, but nasal spray flu vaccines are not).

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