High Dose IL-2 in Combination With Anti-PD-1 in Metastatic Melanoma and Renal Cell Carcinoma

Inclusion Criteria:

- At least 6 weeks of prior anti-PD-1 therapy with documented clinical or radiographic
progression. Last anti-PD-1 therapy must be within 6 months of enrollment.

- Histologically-confirmed diagnosis of unresectable stage III or metastatic (stage IV)
melanoma or renal cell carcinoma

- Measurable disease, defined as at least 1 tumor that fulfills the criteria for a
target lesion according to RECIST 1.1, and obtained by imaging within 28 days prior
registration for protocol therapy.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Adequate hepatic and renal function

- Female subjects of childbearing potential must have confirmed negative urine or serum
pregnancy test prior to drug administration and be willing to use two methods of birth
control.

- Male subjects who are not surgically sterile (vasectomy) must agree to use an adequate
method of contraception (condoms).

Exclusion Criteria:

- Active infection requiring systemic therapy

- Women who are pregnant or breastfeeding.

- Second active malignancy within the past 5 years with the exception of localized basal
or squamous cell skin cancer, in situ cervical or bladder cancer, or localized
prostate cancer under active surveillance.

- Active symptomatic central nervous system (CNS) metastases. Prior treated metastases
or asymptomatic metastases are allowed. Patient can receive radiation between
treatments if deemed medically necessary.

- Surgery within 4 weeks prior to study treatment except for minor procedures.

- Uncontrolled or poorly-controlled hypertension

- Serious or non-healing wounds, ulcers, or bone fractures within 28 days prior to
initiation of study treatment.

- Any arterial thromboembolic events, including but not limited to myocardial
infarction, transient ischemic attack, cerebrovascular accident, or unstable angina,
within 6 months prior to initiation of study treatment.

- Known hypersensitivity to nivolumab or IL-2 or any of their components.

- Known history of active tuberculosis.

- Concurrent systemic steroid therapy with doses above physiologic level (more than 10
mg of prednisone daily)

- Active autoimmune disease, including but not limited to myasthenia gravis, myositis,
autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory
bowel disease, vascular thrombosis associated with anti-phospholipid syndrome,
granulomatosis with polyangiitis, Sjögren's syndrome, Guillain-Barré syndrome,
multiple sclerosis, vasculitis, or glomerulonephritis requiring treatment.