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 confirmed by laboratory testing to have locally advanced or spreading pure adenocarcinoma or pure squamous cell carcinoma of the urinary tract (including the kidney's collecting system, ureter, bladder, or urethra), or testicular germ cell tumors that have stopped responding to standard treatments.
• People whose cancer can be measured on imaging scans, according to a standard measurement system called RECIST 1.1.
• People whose cancer has spread or grown, as shown on cross-sectional imaging such as CT or MRI scans.
• People in certain study groups (Cohorts A1, B1, and C1) who have previously received a type of immunotherapy called anti-PD-1/PD-L1 therapy.
• People in certain study groups (Cohorts A2, B2, and C2) who have never received immune checkpoint inhibitor therapy.
• People who may not have received any systemic (whole-body) treatment before, except those with testicular germ cell tumors, who must have already tried all standard treatments aimed at cure and no longer respond to them.
• People aged 18 or older.
• People who are generally well enough to carry out daily activities, as measured by a standard medical scale (ECOG score of 0 or 1, or Karnofsky score of 70% or higher).
• People whose blood counts and organ function meet the required levels, including: haemoglobin at least 9 g/dL; neutrophil count at least 1,500 per microlitre; platelets at least 100,000 per microlitre; bilirubin within acceptable liver function limits; liver enzyme levels within acceptable limits; and kidney function showing a clearance rate of at least 30 mL/min/1.73m².
• People who can provide enough stored tumour tissue (at least 25 unstained slides) for testing before the study begins, or who are willing to have a fresh tissue sample taken if existing tissue is not sufficient.
• People living with HIV, provided they have been on a stable HIV treatment regimen for at least 3 months, have a CD4 cell count above 200 cells/mm³, and have an undetectable level of virus in their blood.
• People with hepatitis B, provided they are being treated with appropriate antiviral medication at the time of joining, with ongoing monitoring planned.
• People with hepatitis C, provided they are on stable antiviral treatment with no significant liver or blood abnormalities, or have already completed hepatitis C treatment and test negative on a PCR test.
• Women who could become pregnant must be willing to use effective contraception (such as barrier methods, surgical sterilisation, or abstinence) from before joining the study until at least 4 months after the last dose of study medication.
• Men who could father children must be willing to use effective contraception (such as barrier methods, surgical sterilisation, or abstinence) during treatment and for at least 4 months after the last dose of study medication; the trial also recommends that female partners of childbearing potential use effective birth control.
• People who are breastfeeding must be willing to stop breastfeeding from the start of treatment until 4 months after the last dose of pembrolizumab and 3 weeks after the last dose of the other study drug (EV).
• People who are able to understand and are willing to sign a written consent form.

Who may not be able to join:

• People who have received investigational drugs, chemotherapy, immunotherapy, or radiotherapy (other than palliative treatment directed at bone pain) within the 2 weeks before the first study treatment. Note: certain hormone therapies approved for other cancers may be allowed to continue at the treating doctor's discretion.
• People who have previously been treated with EV (enfortumab vedotin) or similar antibody-drug treatments that work in the same way (MMAE-based ADCs).
• People who already have nerve damage affecting sensation or movement rated at grade 2 or higher on a standard medical scale.
• People with a history of severe allergic reactions to drugs chemically similar to EV or pembrolizumab.
• People with brain or central nervous system (CNS) cancer spread that is either causing symptoms or has not yet been treated. People whose brain metastases have been previously treated and fully recovered — and who no longer need steroid medication, and whose brain radiation was completed at least 2 weeks before joining — may still be considered.
• People with an active autoimmune disease that could worsen with pembrolizumab, with some exceptions: certain manageable conditions such as type 1 diabetes, eczema, vitiligo, psoriasis, or thyroid disorders not requiring immune-suppressing treatment may still be eligible; people needing low-dose steroid hormone replacement (up to the equivalent of 10 mg of prednisone per day) may be eligible; people using steroids applied to the skin, inhaled, or used in the eyes or nose (with minimal whole-body effect) may be eligible. People taking higher-dose steroids or other immune-suppressing drugs (such as azathioprine or cyclosporin A) are generally not eligible unless those treatments have been stopped for at least 1 week (for short-term use) or at least 4 weeks (for long-term use) before starting the study.
• People who have had poorly controlled diabetes in the 3 months before the first dose, defined as a blood sugar control marker (HbA1c) of 8% or higher, or between 7% and 8% with related symptoms such as excessive thirst or urination.
• People with active inflammation or ulceration of the cornea (surface of the eye).
• People who have received or are scheduled to receive a live vaccine within 30 days before the first study treatment. Seasonal flu vaccines without live virus and locally approved COVID-19 vaccines are permitted.
• People who are pregnant, confirmed by a blood or urine pregnancy test at the start of the study.
• People with serious, uncontrolled illness that would make it difficult to follow the study requirements, as assessed by medical history, physical examination, and blood tests.
• People with another current or recent cancer (diagnosed within the past 2 years) whose cancer history or treatment could interfere with assessing the safety or effectiveness of the study treatment (confirm with trial site).

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