IVAC MUTANOME Phase I Clinical Trial

This is an interventional treatment trial for Melanoma focused on measuring IVAC MUTANOME, IVAC, personalized therapy, personalized immuno therapy, RB_0004-01, Ribological, Melanoma, cancer vaccine Read More

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