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