A Study of Combination Spartalizumab and Canakinumab in Patients With Localized Clear Cell Renal Cell Carcinoma

Eligibility Criteria

• * Radiographically consistent with or histologically confirmed clear cell RCC or predominantly clear cell RCC
• * Localized non-metastatic RCC T1b-T4NanyM0 or TanyN1M0)
• * Schedule to undergo either partial or radical nephrectomy as part of the treatment plan
• * Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
• * Age ≥ 18 years old at time of consent
• * HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes as defined by the following
• * Cluster of differentiation 4 (CD4+) T cell counts ≥ 350 cells/microliter OR undetectable HIV viral load
• * no history of AIDS-defining opportunistic infection in the last year
• * Normal organ and marrow function as defined below:
• * White blood cell count (WBC) \> 3.0 K/mm3
• * Absolute neutrophil count (ANC) ≥ 1.5 K/mm3
• * Platelets ≥ 100 K/mm3
• * Hemoglobin (Hgb) ≥ 9 g/dL
• * Serum total bilirubin: ≤ 1.5 x upper limit of normal (ULN)
• * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x ULN
• * Serum creatinine ≤ 1.5 x ULN or serum creatinine \> 1.5 - 3 x ULN if calculated
• * creatinine clearance (CrCl) is ≥ 30 mL/min
• * For patients with known chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
• * For patients with a history of hepatitis C virus (HCV) infection, the infection must be treated and cured
• * Willingness to provide written informed consent and HIPAA authorization for the release of personal health information, and the ability to comply with the study requirements (note: HIPAA authorization will be included in the informed consent)
• * Willingness to use barrier contraception from the time of first dose of canakinumab and spartalizumab until 120 days after surgical intervention
• * Presence of distant metastases
• * Presence of active, known or suspected autoimmune disease.
• * No patients with documented, active infections, treated or untreated, may be included in this study
• * Use of any live vaccines against infectious disease within 4 weeks of initiation ot study treatment.
• * Prior therapy with experimental anti-tumor vaccines; any T cell co-stimulation or checkpoint pathways
• * Prior treatment for RCC including surgery, radiation, thermoablation, or systemic therapy
• * Surgery 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)
• * Systemic chronic steroid therapy (≥ 10mg/day prednisone or equivalent) or any immunosuppressive therapy 7 days prior to planned date of first dose of study treatment. Note: Topical, inhaled, nasal and ophthalmic steroids are allowed
• * Allogenic bone marrow or solid organ transplant
• * History of severe hypersensitivity reactions to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction
• * History or current interstitial lung disease or non-infectious pneumonitis requiring the use of home oxygen
• * 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
• * Positive tests for hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA)
• * History of known or suspected autoimmune disease with the following exceptions:
• * Vitiligo
• * Resolved childhood atopic dermatitis
• * Psoriasis (with exception of psoriatic arthritis) not requiring systemic treatment (within the past 2 years).
• * Patients with Grave's disease or Hashimoto's thyroiditis that are now euthyroid clinically and by laboratory testing.
• * History of malignancy within the last 2 years, with the exception of non-melanoma skin cancers and superficial bladder cancer
• * Uncontrolled major active infectious, cardiovascular, pulmonary, hematologic, or psychiatric illnesses that would make the patient a poor study candidate