Study of Neoadjuvant Nivolumab in Patients With Non-metastatic Stage II-IV Clear Cell Renal Cell Carcinoma

Inclusion criteria

(abbreviated):

• Confirmed non-metastatic high-risk clear cell renal cell carcinoma (T2a-T4NanyM0 or TanyN1M0)
• Schedule to undergo either partial or radical nephrectomy as part of treatment plan
• Patient agrees to have a tumor biopsy
• ECOG performance status of 0 or 1
• Adequate organ and marrow function defined by study-specified laboratory tests
• Must use acceptable form of birth control while on study and for approximately 31 weeks post-treatment completion
• Willingness and ability to comply with scheduled visits, treatment plans, lab tests and other study procedures

Exclusion criteria

(abbreviated):

• Other active malignancies within last 3 years (with some exceptions for skin, prostate, cervical, or breast cancer)
• Need for urgent or emergent nephrectomy to relieve symptoms
• Prior treatment for RCC including surgery, radiation, thermoablation or systemic therapy
• Surgery within 28 days of starting study treatment (some exceptions for minor procedures)
• Received live vaccine for infectious diseases within 28 days of starting study treatment
• Prior treatment with any antibody or drug targeting T-cell costimulation or immune checkpoint pathways (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, etc)
• Use of immunosuppressive doses of systemic medications within 14 days prior to starting study drug.
• Current use of immunosuppressive agents
• History of severe hypersensitivity reaction to other monoclonal antibodies
• Current signs or symptoms of severe progressive or uncontrolled hepatic, hematologic, gastrointestinal, endocrine, pulmonary or cardiac disease other than directly related to RCC
• Uncontrolled psychiatric illness/social situations that would limit compliance with study requirements.
• Active infection requiring therapy.
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
• Positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA).
• History of autoimmune disease or syndrome requiring systemic steroids or immunosuppressants (some exceptions apply).
• Pulse oximetry of <92% on room air
• Pregnant or breastfeeding women