Study on Fianlimab and Cemiplimab with or without Ipilimumab or Ipilimumab Plus Nivolumab for First-line Treatment of Advanced Kidney Cancer

Inclusion Criteria

• Must be 18 years or older.
• Must have a confirmed diagnosis of kidney cancer with a clear cell component.
• Cancer must be advanced or metastatic, meaning it cannot be cured with surgery or radiation.
• Must not have received any prior systemic treatment for kidney cancer.
• Must have measurable disease based on specific medical criteria.
• Must provide a tumor tissue sample for analysis.
• Must have adequate organ function as determined by blood tests.
• Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
• Men must agree to use contraception if their partner is of childbearing potential.
• People with controlled HIV or hepatitis B/C infections may participate if certain conditions are met.
• Must be able to understand and agree to follow study procedures.

Exclusion Criteria

• Cannot have received prior systemic therapy for kidney cancer.
• Cannot be taking high doses of steroids or have a history of heart inflammation.
• Cannot have active autoimmune diseases requiring treatment, except for certain conditions like vitiligo or controlled psoriasis.
• Cannot have cancer that has spread to the brain.
• Cannot have active infections requiring treatment.
• Cannot be pregnant or breastfeeding.
• Cannot have other cancers that might interfere with the study.
• Cannot have received live vaccines recently.
• Cannot have allergies to the study drugs.
• Cannot be participating in another clinical trial or have recently participated in one.