Study on Immune Checkpoint Inhibitor Combinations with Axitinib for Untreated Advanced Kidney Cancer

Inclusion Criteria

• Must be in good general health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Must have a risk score of intermediate or poor according to the International Metastatic RCC Database Consortium (IMDC).
• Must have at least one tumor that can be measured.
• Must have a confirmed diagnosis of clear-cell renal cell carcinoma (ccRCC), with or without certain features.
• Must test negative for HIV, hepatitis B, and hepatitis C.

Exclusion Criteria

• Cannot be pregnant or breastfeeding, and must agree to use effective birth control during the study and for a specified time after the last dose of study drugs.
• Cannot have difficulty swallowing pills or have a condition that affects absorption of medication.
• Cannot have received prior treatment for kidney cancer with certain therapies.
• Cannot be using or need to use certain medications that affect liver enzymes.
• Cannot have had major surgery within 4 weeks before starting the study or need major surgery during the study.
• Cannot have uncontrolled high calcium levels or need ongoing treatment for high calcium levels.
• Cannot have untreated or worsening cancer spread to the brain.
• Cannot have a history of certain brain or spinal cord diseases.
• Cannot have uncontrolled pain from tumors.
• Cannot have uncontrolled fluid buildup around the lungs, heart, or abdomen.
• Cannot have moderate to severe liver problems.
• Cannot have uncontrolled high blood pressure or a history of severe high blood pressure issues.
• Cannot have had recent serious heart or blood vessel problems.
• Cannot have certain heart rhythm problems or a fast resting heart rate.
• Cannot have had a recent stroke, heart attack, or blood clot.
• Cannot have certain blood vessel diseases.
• Cannot have tumors affecting the lungs or digestive system in specific ways.
• Cannot have certain digestive system conditions or recent abdominal surgery.
• Cannot have a history of significant bleeding or blood clotting problems.
• Cannot have active or recent autoimmune diseases or immune deficiencies.
• Cannot have used certain immune-suppressing medications recently.
• Cannot have had a stem cell or organ transplant.
• Cannot have certain lung diseases or active lung inflammation.
• Cannot have had another cancer within the last 2 years, except for certain low-risk cancers.
• Cannot have received a live vaccine recently or need one during the study.
• Cannot have active tuberculosis or a severe infection recently.
• Cannot have active or chronic Epstein-Barr virus infection.
• Cannot have used certain antibiotics recently.
• Cannot be allergic to any components of the study drugs.