IVAC MUTANOME Phase I Clinical Trial

Trial status:Study Complete
Trial ID:
RB_0004-01
NCT ID:
NCT02035956
EudraCT ID:
N/A
EU Trial (CTIS) Number:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech RNA Pharmaceuticals GmbH
Collaborator:
N/A
Study Complete

Trial Details

Clinical first-in-human study evaluating the safety, tolerability and immunogenicity of intra-nodal administration of a personalized vaccination with IVAC MUTANOME vaccine with or without initial treatment with RBL001/RBL002 vaccine in patients with advanced melanoma

Medical Condition
  • Skin Cancer
    • Study Drug
  • IVAC MUTANOME, RBL001/RBL002
    • Phase
    Phase 1
    Type
    Interventional
    Estimated Enrolment
    15
    Estimated Trial Date
    Dec 2013 - Feb 2017

    Trial Participant Requirements

    Age
    18 - 99 Years
    Sex
    Female & Male
    Healthy Volunteers
    No
    Inclusion and Exclusion Criteria
    Inclusion criteria

      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

    Trial Locations

    Location
    Status
    Location
    Medizinische Universität Wien
    Vienna, AT-Wien, Austria, 1090
    Status
    Location
    Hautklinik und Poliklinik Universitätsmedizin der Johannes-Gutenberg Universität Mainz
    Mainz, Germany, 55131
    Status
    Location
    Klinik für Dermatologie, Venerologie und Allergologie UMM - Universitätsmedizin Mannheim Medizinische Fakultät Mannheim der Ruprecht-Karls-Universität Heidelberg
    Mannheim, Germany, 68167
    Status