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:

• You have early-stage bladder cancer (non-muscle-invasive) with a type called carcinoma in situ (CIS), with or without other small tumours, and your cancer has not responded well enough to BCG treatment (a common bladder cancer therapy).
• You are not able to have, or have chosen not to have, bladder removal surgery (cystectomy).
• In Phase 2 only: You may also be eligible if you have never had BCG treatment, had only partial BCG treatment, or have high-grade early-stage bladder tumours without CIS that did not respond to BCG.
• You have previously tried an immunotherapy drug called a checkpoint inhibitor and it did not work — you may still be eligible after a waiting period of 30 days (Phase 1) or 3 months (Phase 2).
• You are male, or a female who is not pregnant or breastfeeding, and you are 18 years of age or older.
• If you are a woman who could become pregnant, you must have a negative pregnancy test at the start of the trial.
• You are willing to use highly effective contraception if you are a woman who could become pregnant, or use a condom throughout treatment and for 3 months after if you are male.
• You are generally well enough to carry out light activity or normal daily tasks (confirm with trial site).
• Your blood counts are within acceptable ranges — including white blood cells, red blood cells, and platelets (confirm with trial site).
• Your liver function results are within acceptable ranges (confirm with trial site).
• Your kidneys are working well enough to filter waste from your blood (confirm with trial site).
• Your blood clotting results are within an acceptable range, or stable if you are already on blood-thinning medication (confirm with trial site).
• Your bladder works well enough for you to hold the study drug inside it for at least 60 minutes.

Who may not be able to join:

• You have another active cancer that is progressing or required a change in treatment in the last 24 months (some exceptions may be considered).
• You are currently receiving chemotherapy.
• You have previously had part of your bladder surgically removed.
• You have received any bladder treatment or other cancer therapy within the last 30 days before screening.
• You have recently taken strong immune-suppressing medications, including high-dose steroids.
• You have a history of severe asthma or other serious breathing conditions.
• You have an ongoing problem with urine flowing back from the bladder toward the kidneys, or you have a permanent urinary stent in place.
• You have an unresolved blockage causing a swollen kidney (hydronephrosis).
• You are taking part in another clinical trial involving an experimental drug, or have previously received an experimental gene or immune therapy for your bladder cancer.
• You have had radiation therapy to the pelvis or prostate area within the last 12 months.
• You have had a lung condition called interstitial lung disease or pneumonitis, especially if linked to previous checkpoint inhibitor therapy.
• Your cancer has spread to other parts of the body (metastatic disease).
• You have a history of difficulty with urinary catheterisation that could prevent the study drug being given safely.
• You have an active condition called interstitial cystitis confirmed by examination or biopsy.
• You have an active, uncontrolled infection (bacterial, viral, or fungal) that requires treatment.
• You are known to have HIV, Hepatitis B, or Hepatitis C.
• You have had a significant heart event recently, such as a heart attack within the last 6 months or coronary stenting within the last 8 weeks.
• You have a known allergy to any ingredient in the study drug.
• If you are in the bladder rinse part of the trial: you have a known allergy to a substance called polidocanol.

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