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:

• People aged 18 or older who have been diagnosed with high-risk upper tract urothelial carcinoma (a type of cancer in the urinary tract), confirmed by laboratory analysis of tissue.
• Male participants must agree to use contraception during treatment and for at least 6 months after the last dose, and must agree not to donate sperm during this time.
• Female participants must not be pregnant or breastfeeding, and must either not be capable of becoming pregnant, or agree to use contraception during treatment and for at least 6 months after the last dose.
• A tumor tissue sample must be available — either from a previous biopsy kept on file, or from a newly obtained biopsy of a tumor that has not been previously treated with radiation.
• Participants must have a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity), assessed within 7 days before starting treatment.
• Blood test results taken within 10 days before starting treatment must show a healthy enough level of white blood cells (neutrophils) to meet the trial's minimum threshold.
• Blood test results must show a healthy enough platelet count (cells that help blood clot) to meet the trial's minimum threshold.
• Blood test results must show a healthy enough haemoglobin level (the protein in red blood cells that carries oxygen) to meet the trial's minimum threshold.
• Blood test results must show that kidney function meets the trial's minimum requirements.
• Blood test results must show that liver function, including bilirubin levels (a substance processed by the liver), meets the trial's requirements.
• Blood test results must show that liver enzyme levels (markers of liver health) are within acceptable ranges.
• Blood test results must show that blood clotting function is within acceptable ranges, or within a safe therapeutic range for those already taking blood-thinning medication.

Who may not be able to join:

• Women who are capable of becoming pregnant and have a positive pregnancy test within 72 hours before being assigned to the trial.
• People who have previously been treated with certain types of immunotherapy drugs that target specific immune system pathways (such as anti-PD-1, anti-PD-L1, anti-PD-L2, or similar agents).
• People who have received systemic cancer treatment, including experimental therapies, within 4 weeks before being assigned to the trial (shorter intervals may apply for certain drugs — confirm with trial site), or who have not fully recovered from side effects of previous treatments.
• People who have received radiation therapy within 2 weeks before starting the trial, or who have not recovered from radiation-related side effects.
• People who have received a live vaccine (such as measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, or live nasal flu vaccine) within 30 days before the first dose.
• People who are currently taking part in, or have taken part in, another clinical trial involving an experimental treatment or device within 4 weeks before the first dose.
• People who have been diagnosed with an immune system deficiency, or who are taking immune-suppressing medications (including steroid doses above 10 mg of prednisone per day) within 7 days before the first dose.
• People who have another cancer that is currently active or has required treatment within the past 2 years (some skin cancers or in-situ cancers that have been treated with curative intent may still be eligible — confirm with trial site).
• People with currently active cancer that has spread to the brain or the lining of the brain, unless the brain metastases were previously treated, have been stable for at least 4 weeks on imaging, and have not required steroid treatment for at least 14 days.
• People who have had a severe allergic reaction (grade 3 or higher) to pembrolizumab or any of its ingredients.
• People with an active autoimmune disease that has required systemic medical treatment within the past 2 years (hormone replacement therapies are generally not considered systemic treatment in this context — confirm with trial site).
• People with a history of lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonitis.
• People with an active infection that requires systemic treatment.
• People with a known history of HIV who do not meet specific criteria around viral load, CD4 count, and treatment stability (confirm with trial site for details).
• People with known active Hepatitis B or active Hepatitis C infection, unless Hepatitis B is stable and meeting specific laboratory thresholds, or Hepatitis C has been successfully treated more than 2 weeks prior and the virus is no longer detectable (confirm with trial site).
• People with any medical condition, previous therapy, or laboratory result that, in the treating doctor's opinion, would interfere with the trial or would not be in the participant's best interest.
• People with known psychiatric conditions or substance use disorders that would make it difficult to follow the trial's requirements.
• People who are pregnant, breastfeeding, or planning to conceive or father a child during the study period and up to 120 days after the last dose.
• People who have received an organ or tissue transplant from another person.
• People who have previously been treated with enfortumab vedotin or similar drug-based therapies (MMAE-based ADCs).
• People with an estimated life expectancy of less than 12 weeks.
• People who have had a severe allergic reaction (grade 3 or higher) to any ingredient in enfortumab vedotin or pembrolizumab.
• People with any other underlying medical condition that, in the treating doctor's opinion, would prevent them from safely receiving or tolerating the planned treatment.
• People with active eye conditions such as keratitis (inflammation of the cornea) or corneal ulcers (a superficial form of keratitis may be acceptable if it is being adequately treated — confirm with trial site).

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