Nivolumab and Ipilimumab in Treating Patients With Metastatic Uveal Melanoma
Condition: Metastatic Uveal Melanoma; Stage IV Uveal Melanoma AJCC v7
MeSH terms: Melanoma; Uveal Neoplasms
Intervention: Ipilimumab; Laboratory Biomarker Analysis; Nivolumab
Intervention description: Given IV; Correlative studies; Given IV
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well nivolumab and ipilimumab work in treating patients with
      uveal melanoma that has spread to other places in the body (metastatic). Immunotherapy with
      monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system
      attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to give written informed consent

          -  History of uveal melanoma and documented metastatic disease with at least one
             measurable lesion is required; which is >= 1 cm x 1 cm (on spiral computed tomography
             [CT] or equivalent)

          -  Any number of prior therapies is allowed

          -  White blood cell (WBC) >= 2000/uL

          -  Absolute neutrophil count (ANC) >= 1500/uL

          -  Platelets >= 100 x 10^3/uL

          -  Hemoglobin >= 9 g/dL

          -  Creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) > 40
             mL/min (using the Cockcroft-Gault formula)

          -  Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x ULN for
             patients without liver metastasis, =< 5 x ULN for liver metastases

          -  Bilirubin =< 1.5 x ULN, (except patients with Gilbert's syndrome, who must have a
             total bilirubin less than 3.0 mg/dL)

          -  In suspected patients no active or chronic infection with human immunodeficiency virus
             (HIV), hepatitis B, or hepatitis C

          -  Performance status Eastern Cooperative Oncology Group (ECOG) 0-1

          -  Baseline imaging in the form of CT chest, abdomen, pelvis with oral and intravenous
             contrast within 28 days of study entry; for patients with a contrast allergy, choice
             of alternative body imaging will be at the discretion of the investigator or his
             designee; magnetic resonance imaging (MRI) of the brain is only needed if clinically
             indicated

          -  Prior to start of treatment must be more than 21 days elapsed from surgery, radiation
             therapy, or prior chemotherapy; more than 42 days elapsed from prior immune therapy
             including vaccines

          -  Women of childbearing potential (WOCBP) and fertile men with partners of childbearing
             potential must be using an adequate method of contraception to avoid pregnancy
             throughout the study and for up to 26 weeks after the last dose of investigational
             product, in such a manner that the risk of pregnancy is minimized

        Exclusion Criteria:

          -  Untreated primary uveal melanoma except in cases where metastatic disease is diagnosed
             at the time of primary disease

          -  Metastatic uveal melanoma patients with bone-only disease

          -  Any other malignancy from which the patient has been disease-free for less than 2
             years, with the exception of adequately treated and cured basal or squamous cell skin
             cancer, superficial bladder cancer or carcinoma in situ of the cervix, breast, or
             prostate

          -  Autoimmune disease: Patients with a history of inflammatory bowel disease, including
             ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients
             with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic
             progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune
             vasculitis [e.g., Wegener's Granulomatosis]; motor neuropathy considered of autoimmune
             origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis)

          -  Any underlying medical or psychiatric condition, which in the opinion of the
             investigator will make the administration of ipilimumab hazardous or obscure the
             interpretation of adverse events (AEs), such as a condition associated with frequent
             diarrhea

          -  Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to
             1 month before or after any dose of ipilimumab)

          -  Concomitant therapy with any of the following: tamoxifen, toremifene, IL 2,
             interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy;
             immunosuppressive agents; other investigation therapies; or chronic use of systemic
             corticosteroids greater than physiologic replacement doses; ocular steroid use is
             acceptable; (a) concomitant palliative radiation for the purposes of symptom
             management is allowed

          -  Women of childbearing potential (WOCBP) who: (a) are unwilling or unable to use an
             acceptable method of contraception to avoid pregnancy for their entire study period
             and for up to 26 weeks after cessation of study drug, or (b) have a positive pregnancy
             test at baseline, or (c) are pregnant or breastfeeding

          -  Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
             treatment of either a psychiatric or physical (e.g., infectious) illness