Study on Sacituzumab Govitecan and Nivolumab for High-Risk Muscle-Invasive Urothelial Carcinoma

Inclusion Criteria

• Must be 18 years or older.
• Have a performance status score of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.
• Have a confirmed diagnosis of muscle-invasive urothelial carcinoma in the bladder, ureter, or renal pelvis. Other types of cancer cells, except small cell carcinoma, are allowed.
• Have had surgery to remove the cancer with the intent to cure it, such as radical cystectomy or nephroureterectomy, within the last 180 days.
• Must show no signs of cancer on imaging tests done within 28 days before starting the study treatment.
• May have had prior platinum-based chemotherapy before surgery. If not, must be unable to take Cisplatin or have refused further chemotherapy.
• May have had other investigational treatments before surgery, except for PD-1/PD-L1 inhibitors or Sacituzumab Govitecan.
• Must be at high risk for cancer recurrence based on specific findings from surgery.
• Must have adequate organ and bone marrow function, as shown by specific blood test results.
• Must agree to use effective birth control methods if sexually active.
• Women must not be pregnant and must agree to a pregnancy test before starting the study.
• Must have recovered from any side effects of previous cancer treatments to a mild level, unless they are stable and not significant.
• Must be able to understand and sign a consent form agreeing to participate in the study.

Exclusion Criteria

• Have had only partial surgery to remove the bladder or kidney.
• Have had chemotherapy or other treatments after surgery to remove the cancer.
• Have been treated with PD-1/PD-L1 inhibitors or Sacituzumab Govitecan before starting the study.
• Have had radiation therapy for the cancer.
• Have evidence of cancer spread to other parts of the body.
• Are receiving or planning to receive other investigational treatments.
• Have an active or suspected autoimmune disease.
• Need treatment with high-dose steroids or other immune-suppressing drugs within 14 days before starting the study.
• Have lung conditions like pulmonary fibrosis or pneumonitis.
• Have had major surgery within 28 days or minor surgery within 14 days before starting the study.
• Have another active cancer within the last 3 years, except for certain skin, prostate, or in situ cancers.
• Do not have adequate organ and bone marrow function.
• Have uncontrolled illnesses.
• Have received a live vaccine within 30 days before starting the study.
• Have severe allergies to Nivolumab, Sacituzumab Govitecan, Irinotecan, or their components.