RBL001/RBL002 Phase I Clinical Trial

Trial status:Study Complete
Trial ID:
RB_0001-01
NCT ID:
NCT01684241
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
Study Complete

Trial Details

Clinical first-in-human dose escalation study evaluating the safety and tolerability of intranodal administration of an RNA-based cancer vaccine targeting two tumor-associated antigens in patients with advanced melanoma

Medical Condition
  • Skin Cancer
    • Trial Drug
  • RBL001/RBL002
    • Phase
    Phase 1
    Type
    Interventional
    Estimated Enrolment
    29
    Estimated Trial Date
    Jun 2012 - May 2015

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No
    Inclusion and Exclusion Criteria
    Inclusion criteria

      Inclusion Criteria:

    • Stage IIC, IIIA-C or unresectable stage IV of cutaneous melanoma (AJCC 2009 melanoma classification)
    • 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!)
    • Antigen expression confirmed by RT-PCR analysis from FFPE
    • ≥ 18 years of age
    • Written informed consent (part I and part II)
    • ECOG performance status (PS) 0-1 or Karnofsky Index 70-100 %
    • Life expectancy \> 3 months
    • WBC ≥ 3x109/L
    • Hemoglobin ≥ 10 g/dl
    • Platelet count ≥ 100,000/mm³
    • LDH level \< 2.0 x ULN
    • Negative pregnancy test (measured by β-HCG) for females of childbearing age
    • Suitable lymph nodes for injection using ultrasound guidance

      • Exclusion Criteria:

    • Pregnancy or breastfeeding
    • Primary ocular melanoma
    • Presence of 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
    • Acute or chronic active hepatitis B or C infection, EBV or CMV
    • Receipt of allogenic stem cell transplantation
    • 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, chemotherapy, major surgery, immunotherapy, vaccination, any other concurrent anticancer therapy or any investigational drug within 28 days before the first treatment of this study
    • Minor surgery within 14 days before the first treatment of this study
    • Treatment with Ipilimumab within 84 days before the first treatment of this study
    • Fertile males and females who are unwilling to employ adequate means of contraception (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, Abteilung für Dermatologie
    Vienna, Austria, A-1090
    Status
    Location
    Medizinische Fakultät der Universität Duisburg-Essen
    Essen, Germany, 45122
    Status
    Location
    Universtitätsmedizin der Johannes-Gutenberg Universtität
    Mainz, Germany, 55131
    Status
    Location
    Universitätsklinik Mannheim
    Mannheim, Germany
    Status