Study on Enfortumab Vedotin and Pembrolizumab Before Surgery for Upper Tract Urothelial Cancer

Inclusion Criteria

• Diagnosed with high-grade upper tract urothelial cancer in the kidney or ureter, confirmed by a biopsy or cell test within the last 60 days.
• No small cell carcinoma present; other types are allowed if the main type is urothelial carcinoma.
• Recent imaging shows no spread beyond nearby lymph nodes.
• Eligible for surgery aimed at curing the cancer, as determined by a urologist.
• Eligible for cisplatin treatment, with adequate kidney function and no severe nerve or heart issues.
• Previous local treatment for upper tract cancer is allowed if completed over 6 months ago and side effects have improved.
• History of non-invasive bladder or upper tract cancer is allowed, with certain previous treatments permitted.
• Aged 18 or older.
• Good overall health, with an ECOG performance status of 0 or 1.
• If previously infected with hepatitis B or C, must meet specific criteria for viral control.
• Adequate organ and bone marrow function based on recent blood tests.
• Agree to use effective birth control during and after the study, with women taking a pregnancy test before joining.
• No other medical conditions that would make participation unsafe.
• Willing to sign informed consent and understand the study's nature.

Exclusion Criteria

• Previous treatment with certain immune therapies or antibody-drug conjugates.
• Currently using or recently used immunosuppressive medication, with some exceptions.
• Active or recent autoimmune or inflammatory disorders requiring treatment.
• Evidence of cancer spread beyond nearby lymph nodes or to other organs.
• History of certain invasive cancers within the last 2 years.
• Enrolled in another clinical trial.
• Another active cancer unless treated and in remission for at least 1 year, with some exceptions.
• Only one kidney.
• Pregnant or breastfeeding.
• Severe allergy to study drugs or their components.
• Recent live vaccine.
• Active infection needing treatment.
• Conditions or lab results that could affect study results or participation.
• Known HIV or active tuberculosis infection.
• Psychiatric or substance abuse issues affecting participation.
• Previous organ or tissue transplant.
• Moderate or severe liver dysfunction or uncontrolled diabetes.