Study on Pembrolizumab and BCG for Upper Urinary Tract Cancer Without Kidney Removal

Inclusion Criteria

• Be willing and able to provide written consent to participate.
• Be at least 18 years old.
• Have high-grade upper urinary tract cancer that can be treated with a scope or through a small incision.
• Be unable or unwilling to have surgery to remove the kidney and ureter.
• Provide a tissue sample from a recent biopsy.
• Have a performance status of 0-1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have adequate organ function based on recent lab tests.
• Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use birth control during the study and for 120 days after the last dose.
• Men must agree to use contraception during the study and for 120 days after the last dose.
• Patients who have had previous chemotherapy or radiation for this cancer can join if the cancer has returned and they cannot or do not want surgery.

Exclusion Criteria

• Have active or spreading cancer.
• Have a weakened immune system or are taking medications that suppress the immune system.
• Have had a monoclonal antibody treatment recently.
• Have another progressing cancer that needs treatment, except for certain skin or prostate cancers.
• Have an active autoimmune disease needing treatment in the past two years.
• Have a history of lung inflammation or current lung disease.
• Have an active infection needing treatment.
• Have any condition that could interfere with the study.
• Have psychiatric or substance abuse issues that could affect participation.
• Are pregnant or breastfeeding.
• Have had previous treatments targeting specific immune pathways.
• Have HIV, active Hepatitis B or C, or active tuberculosis.
• Have had a live vaccine recently.
• Have an active urinary tract infection or recent kidney procedure.
• Have muscle-invasive cancer of the renal pelvis or upper urinary tract.