A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC)

Exclusion criteria

• . Chemotherapy, immunotherapy, or other experimental cancer therapy within 2 weeks prior to starting study treatment
• . Must have recovered from all anticancer treatment-related toxicities to Grade 1 or less, except for alopecia and endocrinopathies that are stable on treatment with replacement therapy (immune therapy-related endocrinopathies treated with prednisone 10 mg per day \[or equivalent\] are acceptable).
• . Participants receiving any concomitant systemic therapy for RCC are excluded. Patients must not be scheduled to receive another experimental drug while on this study.
• . Symptomatic brain or leptomeningeal metastases, including participants who continue to require glucocorticoids and/or antiseizure therapy. Treated, asymptomatic brain are leptomeningeal metastases are permitted, provided patient has completed radiation at least 2 weeks prior to day 1 and on a physiologic dose of steroids (prednisone equivalent 10mg daily) for at least 1 week prior to day 1 of study treatments. Stable, untreated brain metastases (based on CNS imaging \> 4 weeks apart) permitted if participants does not require steroids or antiseizure therapy.
• . Has known hypersensitivity to any of the study drugs or excipients, including history of severe allergic, anaphylactic, or other hypersensitivity reactions to fusion proteins, or known hypersensitivity or allergy to Chinese hamster ovary cell products.
• . Active infection requiring systemic therapy within 14 days prior to treatment assignment
• . Symptomatic congestive heart failure of New York heart Association Class III or IV i. Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease ii. Severely impaired lung function as defined as 02 saturation that is 88% or less at rest on room air • uncontrolled hypertension (SBP ≥ 160 mm Hg or DBP ≥ 90 mm Hg) despite treatment with antihypertensives
• . Has evidence of any other medical conditions, psychiatric condition, physical examination or laboratory findings that may interfere with the planned treatment, affect subject compliance or place the subject at high risk from treatment-related complications in the opinion of the Investigator.