Phase 2 Kidney 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 been diagnosed with a high-grade cancer of the upper urinary tract (such as the kidney's collecting system or ureter), confirmed by a tissue sample or biopsy, at a stage that has not spread to distant parts of the body.
• You are not able to receive cisplatin (a common chemotherapy drug) because your kidney function is below a certain level, you have significant hearing loss, or you have chosen not to receive cisplatin-based chemotherapy (as recorded in your medical notes).
• Tissue samples from your diagnosis are available (at least 30 slides, or fewer after discussion with the trial team).
• You are generally well enough to carry out most daily activities (a health performance score of 70% or above on a standard scale).
• Your surgeon has determined that you are a suitable candidate for surgery to remove the kidney, ureter, or both.
• You are 18 years of age or older.
• Your blood test results meet certain minimum requirements for white blood cells, platelets, liver function, and blood clotting.
• If you are HIV positive, you are eligible provided your immune cell count (CD4) is above 200, your virus levels are undetectable, and you are on stable HIV treatment.

Who may not be able to join:

• Your cancer has already spread to other parts of the body (metastatic disease).
• You have received systemic chemotherapy or radiotherapy for bladder urothelial cancer in the past 2 years (previous bladder treatments such as BCG are allowed).
• You have moderate or severe nerve damage causing symptoms such as numbness or tingling in your hands or feet (grade 2 or higher peripheral neuropathy).
• You have an active eye infection or corneal ulcer (a superficial eye surface condition may be allowed if it is being properly treated).
• Your diabetes is not well controlled, based on a specific blood sugar measurement (HbA1c of 8% or above, or 7–8% with related symptoms).
• You have unstable chest pain (unstable angina).
• You have moderate to severe heart failure.
• You have had a heart attack within the past 6 months.
• You have had a stroke within the past 6 months.
• You have an active or uncontrolled bleeding disorder (being on a stable dose of blood thinners is permitted).
• You have had a major surgical procedure within the past 28 days (certain minor bladder procedures are allowed).
• You have a serious wound, ulcer, or bone fracture that is not healing.
• You have active tuberculosis.
• You have had another cancer that was active within the past 2 years, unless it was an early-stage cancer that has been fully treated with no signs of return and is unlikely to affect the study results.
• You have previously been treated with enfortumab vedotin or a similar type of drug (MMAE-based antibody-drug conjugates).
• You have active Hepatitis B or Hepatitis C infection.
• You are currently pregnant or breastfeeding, or have a positive pregnancy test within 14 days of starting the trial.
• You have had a severe allergic reaction (grade 3 or above) to enfortumab vedotin or any of its ingredients.
• You are a man who is unwilling to use contraception during treatment and for at least 31 weeks after the last dose.
• You are a woman who could become pregnant and are not willing or able to use an approved form of contraception during treatment and for at least 23 weeks after the last dose.
• You are currently being held involuntarily for psychiatric or medical treatment.
• You are unable to follow the study procedures or attend follow-up appointments.

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