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
cancer types.
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.
