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 have been diagnosed with muscle-invasive bladder cancer (a specific type and stage) confirmed by tissue testing within the past 180 days before starting pre-surgery treatment
• People who had a CT scan, MRI, or PET scan of the chest, abdomen, and pelvis within 60 days before starting pre-surgery treatment to confirm the cancer stage
• People who have had a surgical procedure to remove bladder tumours (called TURBT), including tissue samples taken from multiple specific areas of the bladder, within 60 days after finishing pre-surgery treatment — and this procedure must have been done within 90 days before joining the trial
• People whose imaging scans after pre-surgery treatment showed little or no remaining disease in the bladder (stage T0 or T1)
• People who have had chest, abdomen, and pelvis imaging (CT, MRI, or PET-CT) within 60 days after finishing pre-surgery treatment
• People with lymph nodes measuring 1.0 cm or larger on imaging after pre-surgery treatment must have had a PET-CT scan within 70 days before joining; if the PET-CT result was negative, a biopsy may not be required unless there is strong clinical concern (confirm with trial site)
• People who received at least 3 and no more than 6 cycles of an FDA-approved pre-surgery treatment for muscle-invasive bladder cancer — this includes certain cisplatin-based chemotherapy combinations, dose-dense MVAC chemotherapy, or enfortumab vedotin with a PD-1/L1 inhibitor
• People aged 18 or older at the time of joining the trial
• People with a general health/activity level rated 0–2 on the Zubrod performance scale (meaning able to carry out at least some daily activities)
• People who have had a full medical history review and physical examination within 28 days before joining
• People whose recent blood test results (within 28 days before joining) meet specific levels for white blood cells, neutrophils, and platelets
• People whose recent liver function test results (within 28 days before joining) fall within acceptable ranges; people with a condition called Gilbert's disease may have a higher allowable bilirubin level (confirm with trial site)
• People whose kidney function test results (within 28 days before joining) fall within acceptable ranges
• People with a history of heart disease or treatment with heart-affecting medicines whose heart function is rated Class II or better using a standard heart classification scale
• People living with HIV who are on effective anti-retroviral treatment and have had an undetectable viral load on testing within the past 6 months
• People with chronic hepatitis B who have an undetectable viral load while on appropriate treatment
• People with a history of hepatitis C who have been treated and have an undetectable viral load (considered cured)
• People who have given written informed consent after being told about the investigational nature of the trial; people with impaired decision-making capacity may have a legally authorised representative provide consent on their behalf

Who may not be able to join:

• People whose cancer has progressed to a more advanced stage (T2 or higher, or spread to lymph nodes or other parts of the body) after pre-surgery treatment
• People whose tumour contains certain cell types, specifically small cell, neuroendocrine carcinoma, or plasmacytoid variants
• People who have had bladder cancer or a related cancer type at a site outside the bladder within the past 24 months, unless it was a lower-stage cancer of the upper urinary tract and the affected kidney and ureter were fully removed
• People who have previously received certain immune checkpoint or targeted therapies (such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 antibodies, enfortumab vedotin, or similar drugs) for any reason other than as pre-surgery treatment for muscle-invasive bladder cancer
• People who have previously had radiation therapy to the pelvis
• People who have received a live attenuated vaccine within 28 days before joining the trial
• People who are taking high-dose steroid medications (more than 10 mg per day of prednisone or equivalent) or other immune-suppressing medications at the time of joining
• People who are currently pregnant or breastfeeding; people of reproductive potential must have agreed to use effective contraception
• People with another current or prior cancer whose history or treatment could, in the treating doctor's opinion, interfere with assessing the safety or effectiveness of this trial's treatment

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