SBRT With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer

Prior treatment

• Treatment with prior systemic therapy in the adjuvant or metastatic setting for renal cell carcinoma.
• Previous abdominal radiation precluding SBRT.
• History of auto-immune disorder precluding treatment with ipilimumab or nivolumab.
• Chronic corticosteroid use or other chronic immune suppressive therapy. (Participants are permitted the use of topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Adrenal replacement steroid doses of prednisone ≤ 10 mg daily are permitted).

Other illness

• History of ataxia telangiectasia or other radiation sensitivity disorders.

Other

• A maximum primary renal lesion size of 20 cm or greater.
• Candidate for cytoreductive nephrectomy, unless a patient has refused cytoreductive nephrectomy (in this case, a discussion of cytoreductive nephrectomy and patient refusal must be documented).
• Kanofsky Performance (KPS) score below 60 (see Appendix III).
• Use of medicinal herbal preparations (not including medical cannabis) unless prescribed by a treating physician.
• Inability to lie flat for at least 30 minutes without moving.
• Pregnant or lactating women.
• Geographic inaccessibility for follow-up.
• Inability to provide informed consent.

• Biopsy proven renal cell carcinoma of any histology.
• Imaging proven metastatic disease based on CT or MRI within 10 weeks of screening.
• Intermediate/poor risk disease based on IMDC criteria (see Appendix II).
• Primary kidney lesion amenable to SBRT.
• Eligible for standard of care delivery of ipilimumab and nivolumab (I/N) according to approved product monograph.