Single Arm Trial of Tumor-Treating Fields in Combination With Nivolumab and Ipilimumab in Metastatic Uveal Melanoma

Inclusion Criteria:

Patient has histologically or cytologically confirmed metastatic uveal melanoma with predominant liver involvement
Age 18 years or older and willing and able to provide informed consent
WOCBP must have a negative serum pregnancy test documented with 72 hours of first administration of drug
Sexually active and WOCBP, patient and partner must agree to use adequate contraception
Normal organ and marrow function
ECOG 0-1
Life expectancy of 3 months or greater

Exclusion Criteria:

History of previous grade 3, life threatening immune related adverse event (irAE) from prior checkpoint inhibitor therapy
Prior treatment with anti cytotoxic T-Lymphocyte-Associated protein 4 (CTLA-4) therapy within 90 days of C1D1 of study treatment
Prior anti-cancer therapy (systemic, regional or radiation) within 2 weeks of C1D1 of study treatment
AEs from prior anticancer therapies that have not resolved to grade 1 or less, other than endocrine related irAEs for which patients are on appropriate replacement therapy (ie hypothyroidism, adrenal insufficiency, type 1 diabetes)
History of or active autoimmune disease requiring systemic corticosteroid or immunosuppressive therapy. (Patients who have limited autoimmune disease not requiring systemic therapy or autoimmune disease that is unlikely to recur, such as ulcerative colitis s/p colectomy, will be allowed to enroll.)
Serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive an experimental research drug.
Patient is unwilling or unable to comply with study procedures
Patients with implanted pacemaker, defibrillator, nerve stimulator or other active electronic medical devices; sensitive to conductive hydrogels used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes typically used for TTFields studies.