Phase 2 Kidney 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:

• Adults aged 18 or older who have been diagnosed with high-grade upper tract urothelial cancer (a type of cancer in the lining of the kidney or ureter), confirmed through biopsy, imaging, or urine testing
• People who have either refused the main surgery for this cancer (removal of the kidney and ureter), or whose medical team considers them at too high a risk for serious complications from that surgery
• People who have not previously received systemic (whole-body) treatment for advanced or spreading urothelial cancer, with some exceptions for those who had certain chemotherapy more than 12 months ago
• People who may have a small amount of cancer spread to a single nearby lymph node (no larger than 2 cm)
• People whose general health and ability to carry out daily activities falls within a certain acceptable range, as measured by a standard medical scoring tool (confirm with trial site)
• People whose blood counts and liver function meet specific minimum levels set by the trial (blood transfusions to help meet these levels are permitted)
• People with stored tumour tissue available from a previous biopsy or procedure
• Women who could become pregnant must agree to use highly effective contraception during the trial and for at least 6 months after the last dose, have a negative pregnancy test before starting, agree not to breastfeed or donate eggs, and agree not to try to become pregnant during that period
• Men who could father children must agree to use highly effective contraception during the trial and for at least 6 months after the last dose, must not donate sperm during that period, and must take precautions if their partner is pregnant or breastfeeding
• People who are willing and able to provide written consent to participate

Who may not be able to join:

• People who have previously been treated with enfortumab vedotin or similar antibody-drug therapies that use the same active component (MMAE)
• People who have previously received certain immunotherapy drugs known as PD-1 or PD-L1 inhibitors (such as pembrolizumab, nivolumab, atezolizumab, durvalumab, or avelumab) for any cancer
• People who have previously received other types of immune checkpoint therapy targeting certain immune system pathways (confirm with trial site)
• People who have had other cancer treatments (chemotherapy, biologics, or experimental treatments) that were completed less than 4 weeks before the trial would begin
• People with poorly controlled diabetes (as measured by a specific blood test result)
• People whose doctors estimate they have less than 12 weeks to live
• People who currently have moderate or severe nerve damage causing numbness, tingling, or weakness (Grade 2 or higher neuropathy)
• People who still have significant ongoing side effects from previous cancer treatments that have not settled down to a mild level
• People currently receiving treatment for an active infection (viral, bacterial, or fungal) at the time of starting the trial
• People with active hepatitis B or active hepatitis C infection (people who have been fully cured of hepatitis C may still be eligible)
• People with a known history of HIV infection
• People who require high doses of steroid medications or other drugs that suppress the immune system
• People with another active cancer, other than certain low-risk skin cancers or a specific type of prostate cancer relapse (people who have completed treatment for another cancer and are considered at low risk of it returning may still be considered)
• People with a history of certain previous urothelial cancers of the bladder or the other ureter/kidney (these cases will be reviewed individually by the trial team)
• People who have had a stroke, mini-stroke, unstable chest pain, heart attack, or severe heart failure symptoms within the past 6 months
• People who have had radiation therapy within 2 weeks before starting the trial, or who have not recovered from its side effects
• People who have had major surgery within 4 weeks before starting the trial, or who have not fully recovered
• People who have had a severe allergic reaction (Grade 3 or higher) to any ingredient in the study drugs (enfortumab vedotin, pembrolizumab, certain platinum-based chemotherapy, or gemcitabine)
• People with active eye conditions involving the cornea (the front surface of the eye), unless adequately treated in the opinion of the medical team
• People with an autoimmune disease that has required systemic medical treatment within the past 2 years (some autoimmune-related conditions may still be eligible — confirm with trial site)
• People with certain lung conditions, including a history of specific types of lung scarring or inflammation, or evidence of active lung inflammation on a recent scan
• People who have previously received a bone marrow or organ transplant from another person
• People who have received a live or live-attenuated vaccine within 30 days before starting the trial (most standard vaccines, including approved COVID-19 vaccines, are permitted — confirm with trial site)
• People with active tuberculosis
• People with other significant medical, psychiatric, or substance use conditions that, in the medical team's judgement, would make participating in the trial unsafe or not feasible

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