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 to take part voluntarily, can give written consent, and are able to follow the study schedule and requirements.
• People who are 18 years of age or older at the time of signing the consent form.
• People who have been diagnosed with bladder cancer (urothelial type) with remaining cancer tissue after a TURBT procedure, where the cancer is at a specific stage (cT2–T4a, with no spread to lymph nodes or other organs), confirmed by both tissue testing and imaging. For people with mixed-type bladder cancer, at least 50% of the cancer must be urothelial.
• People whose cancer shows specific genetic changes (such as mutations or copy number variations in genes like CDKN2A or CDKN2B) that suggest the cell cycle pathway is activated.
• People with a good general level of physical functioning, rated 0 or 1 on a standard medical scale (ECOG), meaning they are either fully active or have minor limitations.
• People who are not suitable for the chemotherapy drug cisplatin, as determined by the treating doctor, because of at least one of the following: reduced physical functioning; reduced kidney function; significant hearing loss; significant nerve-related problems; or serious heart failure.
• People whose doctor has assessed them as suitable for, and willing to undergo, bladder removal surgery (radical cystectomy) after completing the study treatment.
• People who have tissue samples collected during their TURBT procedure available, along with the related pathology reports.
• People whose recent blood test results (taken within 14 days before joining) show that their blood counts, liver function, kidney function, and clotting levels meet the required thresholds, and whose lung function results suggest they can tolerate major abdominal surgery.
• Women who are not pregnant, or women who could potentially become pregnant but are willing to use a highly effective form of contraception throughout the study and for at least 120 days after the last dose of study treatment, and who have a negative pregnancy test within 7 days before joining.

Who may not be able to join:

• People who have previously received certain immunotherapy treatments targeting specific immune checkpoint proteins (such as PD-1, PD-L1, PD-L2, or CTLA4).
• People who have received other approved cancer treatments or immune-modifying medicines (such as interferon or interleukin-2) within 28 days before joining.
• People who have previously had radiotherapy directed at the bladder.
• People who have received cancer drug treatments, unless: prior chemotherapy was completed at least 12 months before the start of study treatment, or local bladder chemotherapy or immunotherapy was stopped at least one week before starting the study treatment.
• People who have had major surgery or a serious physical injury within 28 days before joining (note: TURBT and placement of vascular access lines are not counted as major surgery).
• People who have had a serious active infection requiring antibiotic, antifungal, or antiviral treatment within 14 days before joining.
• People who have received a live vaccine within 28 days before joining (standard flu shots using inactivated vaccines are generally permitted, but nasal spray flu vaccines are not).
• People with active autoimmune diseases that require ongoing systemic treatment and that may interfere with the study treatment, as determined by the treating doctor.
• People who require long-term treatment with hormones or other immune-suppressing medicines in a way that may interfere with the study treatment, as determined by the treating doctor.
• People with a history of certain electrolyte abnormalities or low blood protein, lung inflammation (interstitial lung disease or pneumonitis), or poorly controlled conditions such as diabetes, high blood pressure, or active heart disease (including unstable chest pain, heart attack, symptomatic heart failure, or serious irregular heart rhythms within the past 6 months), where these may affect study treatment as determined by the treating doctor.
• People with untreated chronic hepatitis B, or hepatitis B carriers whose virus levels are too high (HBV DNA at or above 500 IU/mL). People with stable, well-controlled hepatitis B on continuous antiviral treatment may be considered (confirm with trial site).
• People with active hepatitis C infection. People who test negative for hepatitis C, or who test positive for the antibody but negative for the active virus, may be considered (confirm with trial site).
• People with a history of immune deficiency conditions (including HIV), or who have had a bone marrow or organ transplant.
• People with a known serious allergic reaction to any monoclonal antibody medicines.
• People with a known serious allergic reaction to any of the study drugs or their ingredients.
• People who still have unresolved side effects from previous treatments that have not returned to their prior baseline or stabilised, unless those effects are considered low risk by the treating doctor.
• People with underlying health conditions, or alcohol or drug dependency, that could make the study treatment unsafe or make it difficult to interpret the results.
• People who are currently taking part in another clinical trial involving a treatment intervention.

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