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

Exclusion Criteria

• •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