IVAC MUTANOME Phase I Clinical Trial

Inclusion Criteria:

* Malignant Melanoma, resectable stage IIIA-C and IV (AJCC 2009 melanoma classification)
* Patients with unresectable Malignant Melanoma stage IIIA-C in complete remission, partial remission or stable disease after treatment with vemurafenib or patients with slow progressive disease.
* Malignant Melanoma, unresectable stage IV (AJCC 2009 melanoma classification) in complete remission, partial remission or stable disease after treatment with vemurafenib
* All lines of treatment for malignant melanoma are accepted.
* First line therapy for subjects not eligible or declining other first line therapies after all available treatment options have been transparently disclosed (to be documented in patient medical record).
* ≥ 18 years of age
* Written informed consent
* ECOG performance status (PS) 0-1 (appendix G)
* Life expectancy \> 6 months
* WBC ≥ 3x109/L
* Haemoglobin ≥ 10 g/dl
* Platelet count ≥ 100,000/mm³
* LDH level \< 2.0 x ULN
* Negative pregnancy test (measured by β-HCG) for females which are childbearing potential
* Suitable lymph nodes for injection using ultrasound guidance

Exclusion Criteria:

* Pregnancy or breastfeeding
* Primary ocular melanoma
* History (\< 5 years) of a second malignancy other than squamous or basal cell carcinoma, non-active prostate cancer or cervical carcinoma in situ
* Brain metastases
* Known or symptomatic pleural effusions and/or ascites
* Known hypersensitivity to the active substance or to any of the excipients
* A serious local infection (e.g. cellulitis, abscess) or systemic infection (e.g. pneumonia, septicemia) which requires systemic antibiotic treatment within 2 weeks prior to the first dose of study medication
* Positive test for acute or chronic active hepatitis B or C infection, acute EBV or acute CMV injection
* Clinically relevant autoimmune disease
* Systemic immune suppression:
* HIV disease
* Use of chronic oral or systemic steroid medication (topical or inhalational steroids are permitted)
* Other clinical relevant systemic immune suppression
* Symptomatic congestive heart failure (NYHA 3 or 4)
* Unstable angina pectoris
* Radiotherapy within two weeks, myelosuppressive chemotherapy, ipilimumab and major surgery within 4 weeks/28 days before the first treatment. Interferon and approved BRAF inhibitors will be allowed as concurrent treatment.
* Any investigational drug within 4 weeks/28 days or 5 half-lives depending on what gives the longer range before the first treatment of this study
* Minor surgery within 14 days before the first treatment of this study
* Fertile males and females who are unwilling to use a highly effective method of birth control (less than 1% per year, e.g. condom with spermicide, diaphragm with spermicide, birth control pills, injections, patches or intrauterine device) during study treatment and 28 days after the last dose of study treatment
* Presence of a serious concurrent illness or other condition (e.g. psychological, family, sociological, or geographical circumstances) that does not permit adequate follow-up and compliance with the protocol