The purpose of this study is to study the effectiveness of the combination of drugs called
nivolumab and high dose interleukin-2 (HD IL-2) as a treatment for metastatic (the cancer has
spread) melanoma or renal cell carcinoma.
HD IL-2 is a drug that was designed to help white blood cells regulate their immune response.
HD IL-2 is given intravenously (IV, through a needle into a vein). IL-2 is approved by the
FDA for the treatment of metastatic renal cell carcinoma and metastatic melanoma.
Nivolumab is a type of drug called a checkpoint inhibitor that was designed to block a
protein, allowing the body's immune system to recognize and fight cancer cells. Nivolumab is
also given intravenously. Nivolumab is approved by the FDA for the treatment of several
- 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
- Male subjects who are not surgically sterile (vasectomy) must agree to use an adequate
method of contraception (condoms).
- 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.