L-selenomethionine with Axitinib and Pembrolizumab for the Treatment of Locally Advanced or Metastatic Clear Cell Kidney Cancer

Inclusion Criteria

• Written and voluntary informed consent
• Histologically and radiologically confirmed locally advanced or metastatic clear cell renal cell carcinoma (ccRCC). Locally advanced is defined as non resectable in the opinion of the treating providers. Participants must be treatment naive in metastatic setting. Prior immunotherapy treatment in adjuvant setting is allowed
• >= 18 years of age
• At least one Response Evaluation Criteria in Solid Tumors (RECIST 1.1)-defined target lesion that has not been irradiated
• Eastern Cooperative Oncology Group performance status of 0 (fully active, able to carry on all pre-disease performance without restriction) or 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, such as light housework or office work)
• Creatinine level within normal institutional limit, or creatinine clearance > 15 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal, calculated using the Cockcroft-Gault formula
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 3.0 x institutional upper limit of normal OR < 5 x institutional upper limit of normal in cases of liver metastases
• Total bilirubin =< 1.5 times upper limit of normal (ULN)
• Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
• Platelets >= 100 x 10^9/L
• Hemoglobin >= 7.0 g/dL
• Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP =< 150/90 mm Hg with no change in antihypertensive medications within 1 week before randomization/allocation
• Female subjects of childbearing potential and non-sterilized male subjects who intend to be sexually active during the study must agree to use a highly effective method of contraception from the time of screening, throughout the total duration of the drug treatment, and during the 6 month post-drug washout period

Exclusion Criteria

• Patients with a prior or concurrent malignancy whose natural history or treatment may have the potential to interfere with the safety or efficacy assessment of the investigational regimen
• Untreated metastases in the central nervous system
• Pregnant or breastfeeding
• Present use or anticipated need for cytochrome P450 (CYP) 3A4-inhibiting, CYP3A4-inducing drugs (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole, rifampin, phenytoin, carbamazepine, rifabutin, rifapentine, phenobarbital, and St. John's wort, bosentan, efavirenz, etravirine, modafinil, and nafcillin)
• Myocardial infarction, uncontrolled angina, congestive heart failure, or cerebrovascular accident within previous 6 months. Participants with history of deep vein thrombosis or pulmonary embolism, at provider discretion
• Major surgery within 4 weeks of starting study treatment
• Patients with human immunodeficiency virus (HIV) infection with CD4+ T-cell (CD4+) counts < 350 cells/uL
• Patients with HIV infection and a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections