A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Patients with Previously Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma

Prior treatment

• Prior treatment for localized and/or metastatic RCC with systemic RCC directed therapy
• Ongoing use or anticipated need for treatment with a strong CYP3A4/5 inhibitor or inducer
• Symptomatic lesions amenable to palliative radiotherapy should be treated prior to enrollment.

Other illness

• History of leptomeningeal disease
• Moderate to severe hepatic impairment (Child-Pugh B or C)

Other

• Symptomatic, untreated, or actively progressing CNS metastases

• International Metastatic Renal Cell Carcinoma Database Consortium IMDC risk intermediate (score of 1 or 2), or poor (score of 3 to 6)
• Measurable disease, at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
• Adequate hematologic and end-organ function (within 14 days prior to study treatment)
• Histologically confirmed clear-cell renal cell carcinoma renal cell carcinoma (ccRCC) with or without sarcomatoid features; non-clear-cell renal cell carcinoma (nccRCC) subtypes (papillary, chromophobe, and unclassified) are not allowed.
• Negative hepatitis B surface antigen (HBsAg) test and hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
• Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening