Clinical trial NCT02275416 (phase 1/phase 2, status: active, not recruiting)
Conditions: malignant melanoma
ICD codes: C43.0, C43.31, C43.51, C43.9, C43.4, C43.52, C43.10
Drugs: ipilimumab
SMILES: COC1=CC=CC=C1OCC(O)CO
Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically confirmed diagnosis of unresectable or metastatic
             malignant melanoma, including cutaneous, ocular, mucosal and unknown primary tumour.

          2. Unresectable Stage III or Stage IV melanoma (AJCC 2010)

          3. Prior adjuvant melanoma therapy is permitted; any number of previous treatments for
             melanoma is permitted.

          4. ECOG performance status of 0 or 1 (see Error! Reference source not found.).

          5. Men and women ≥ 18 years of age

          6. Adequate hematologic, renal and hepatic function, specifically:

               1. WBC ≥ 2500/μL

               2. Absolute neutrophil count (ANC) ≥ 1000/uL

               3. Platelets ≥ 75 x 103/μL

               4. Haemoglobin ≥ 9 g/dL

               5. Creatinine ≤ 2.5 x ULN

               6. AST/ALT ≤ 3 x ULN for patients without liver metastasis; ≤ 5 x ULN for patients
                  with liver metastasis

               7. Total bilirubin ≤ 3 x ULN, (except patients with Gilbert's Syndrome, who must
                  have a total bilirubin less than 3.0 mg/dL)

          7. Women of childbearing potential and men must be using an acceptable method as
             described in the protocol to prevent pregnancy.

          8. Signed informed consent and expected cooperation of the patients for the treatment and
             follow up must be obtained and documented according to ICH GCP, and national/local
             regulations.

        Exclusion Criteria:

          1. History of or current active autoimmune diseases, including but not limited to
             inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune
             hepatitis, systemic sclerosis (scleroderma and variants), systemic lupus
             erythematosus, autoimmune vasculitis, autoimmune neuropathies (e.g. Guillain-Barre
             syndrome). Patients with vitiligo are not excluded.

          2. MRI detected active brain metastasis witch require other therapies such as surgery
             and/or radiation therapy. Patients already treated for their brain metastasis, surgery
             or radiation therapy, and have had stable disease for more than two month and NOT
             requiring steroids may however be included in this study.

          3. Uncontrolled infectious diseases - requires negative tests for clinically suspected
             human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus
             (HCV).

          4. History of or current immunodeficiency disease, splenectomy or splenic irradiation

          5. Prior allogeneic stem cell transplantation

          6. Pregnancy

          7. Women who are breastfeeding

          8. Any underlying medical or psychiatric condition, which in the opinion of the
             Investigator, will make the administration of study drug hazardous or obscure the
             interpretation of Adverse Events, such as a condition associated with frequent
             diarrhoea

          9. History of allergic reaction to parenteral administered recombinant protein product

         10. History of another malignancy that in the opinion of the investigator may compromise
             the outcome of the study

         11. Any reason why, in the opinion of the investigator, the patient should not
             participate.

         12. Known serious reactions or hypersensitivity to any components of the UV1 vaccine or
             similar peptide based vaccines

         13. Known hypersensitivity to GM-CSF

         14. Known hypersensitivity to any of the excipients of the investigational products

         15. Concomitant use of antithrombotic agents with the exception of platelet inhibitors.