Clinical trial NCT02626962 (phase 2, status: active, not recruiting)
Conditions: uveal melanoma
ICD codes: C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4
Drugs: ipilimumab, nivolumab
SMILES: COC1=CC=CC=C1OCC(O)CO, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent must be provided;

          2. Patients must have a histological diagnosis of uveal melanoma;

          3. Progressive metastatic disease at baseline. Progressive disease is defined as new or
             progressive lesions on cross-sectional imaging;

          4. Age>18 years;

          5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1;

          6. Measurable disease by CT or MRI per RECIST 1.1 criteria;

        Exclusion Criteria:

          1. Prior systemic treatment for metastatic uveal melanoma.

          2. Prior malignancy active within the previous 3 years except for locally curable cancers
             that have been apparently cured, such as basal or squamous cell skin cancer,
             superficial bladder cancer, carcinoma in situ of cervix or breast, or incidental
             prostate cancer.

          3. 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 (eg, rheumatoid arthritis, systemic progressive
             sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg,
             Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g.
             Guillain-Barre Syndrome and Myasthenia Gravis). Subjects with vitiligo, type I
             diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring
             hormone replacement, psoriasis not requiring systemic treatment, or conditions not
             expected to recur in the absence of an external trigger are permitted to enroll.

          4. Any underlying medical or psychiatric condition, which in the opinion of the
             investigator will make the administration of nivolumab and ipilimumab hazardous or
             obscure the interpretation of Advers Events (AEs), such as a condition associated with
             frequent diarrhea.

          5. Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to
             1 month before or after any dose of nivolumab and ipilimumab).

          6. A history of prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4
             antibody, or any other antibody or drug specifically targeting T-cell costimulation or
             immune checkpoint pathways.

          7. Concomitant therapy with any of the following: Interleukin (IL) -2, interferon, or
             other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive
             agents; other investigation therapies; or chronic use of systemic corticosteroids,
             defined as >10mg daily prednisone equivalents. Inhaled or topical steroids, and
             adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the
             absence of active autoimmune disease.

          8. Active brain metastases or leptomeningeal metastases. Subjects with brain metastases
             are eligible if these have been treated and there is no magnetic resonance imaging
             (MRI) evidence of progression for at least 8 weeks after treatment is complete and
             within 28 days prior to first dose of study drug administration. There must also be no
             requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day
             prednisone equivalents) for at least 2 weeks prior to study drug administration.

          9. Women of childbearing potential (WOCBP) as defined below, who:

               -  are unwilling or unable to use an acceptable method of contraception to avoid
                  pregnancy for their entire study period and for at least 8 weeks after cessation
                  of study drug, or

               -  have a positive pregnancy test at baseline, or

               -  are pregnant or breastfeeding.