Nivolumab and Stereotactic Ablative Radiation Therapy (SAbR) for Metastatic Clear Cell Renal Cell Carcinoma

Inclusion Criteria

• •At least 18 years of age
• •Willing and able to provide consent
• •Pathologic diagnosis of metastatic RCC with clear cell component
• •Measurable disease in at least 2 non-radiated sites. Progression or intolerance to at least one prior systemic anti-angiogenic therapy.
• •Eligible for extra-CNS SAbR to 1-6 sites of disease
• •Must have received at least one prior anti-angiogenic therapy in the advanced or metastatic setting. Prior cytokine therapy (eg, IL-2, IFN-α), vaccine therapy, or treatment with cytotoxic therapy is also allowed but not any other drug specifically targeting T-cell co-stimulation or checkpoint pathways.
• •Previous treatment with surgery, radiation, chemotherapy, targeted agents (see above) are allowed provided that: Chemotherapy/Major surgery was administered \> 14 days before the start Nivolumab; Minor surgery, radiation, or any targeted agents were administered \> 7 days before the start of Nivolumab
• •Performance status ECOG 0, 1, 2 or 3.
• •Adequate organ and marrow function as defined below (obtained within 14 days of first dose of drug):
• •* leukocytes≥ 2,000/mcL
• •* absolute neutrophil count ≥ 1,500/mcL
• •* platelets ≥ 50,000/mcl
• •* total bilirubin ≤ 2mg/dL
• •* AST(SGOT)/ALT(SPGT) ≤ 3 X institutional upper limit of normal
• •Women of child-bearing potential
• •* female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• •* must have a negative serum or urine pregnancy test within 24 hours prior to the start of investigational product.
• •* Women must not be breastfeeding.
• •* must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and contraception should be continued for a period of 30 days plus the time required for the investigational drug to undergo five half lives.
• •* Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• •* Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Contraception should be continued for a period of 90 days plus the time required for the investigational drug to undergo five half lives. This is equivalent to 31 weeks after discontinuation of Nivolumab.
• •Adequate Renal function with Cr ≤ 2.5 mg/dL.