Study on Cemiplimab and Fianlimab for People with Clear Cell Kidney Cancer

Inclusion Criteria

• Must be 18 years or older.
• Must be able to provide informed consent or have a legal representative to do so.
• Must sign an approved consent form.
• Must be scheduled for kidney surgery for high-risk, non-metastatic clear cell kidney cancer.
  • Non-metastatic means the cancer hasn't spread beyond nearby lymph nodes.
  • High-risk is defined as having a 40% or higher chance of cancer spreading within 12 years.
• Must have a biopsy to confirm clear cell kidney cancer before starting treatment.
• Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Must have adequate organ and bone marrow function based on specific blood test results taken within 14 days before starting treatment.

Exclusion Criteria

• Have received any previous treatment for kidney cancer.
• Have received any immune checkpoint inhibitor therapy for any condition.
• Cannot safely delay surgery by 9 weeks as determined by the surgeon.
• Are taking any other investigational drugs.
• Have a history of severe allergic reactions to similar drugs.
• Have uncontrolled health issues like infections, heart failure, or unstable heart conditions.
• Have a history of heart inflammation (myocarditis).
• Have certain heart enzyme levels that are too high.
• Have active or recent autoimmune diseases that could affect vital organs or require immune-suppressing treatment.
• Require systemic treatment with corticosteroids or other immune-suppressing drugs within 14 days of starting the study.
• Have had another cancer within the last 2 years, except for certain skin cancers or low-grade tumors.
• Have had a stem cell or organ transplant.
• Have a significant infection requiring treatment within 2 weeks before starting the study.
• Have received a live vaccine within 30 days before starting the study.
• Have uncontrolled HIV, hepatitis B, or hepatitis C infections.
• Women who are pregnant or breastfeeding.
• Women of childbearing potential who are not using effective birth control during the study and for 6 months after.
• Men with partners of childbearing potential who are not using condoms during the study and for 6 months after.
• Women must agree not to donate eggs during the study and for 6 months after.
• Men must agree not to donate sperm during the study and for 6 months after.