RNA-Immunotherapy of IVAC_W_bre1_uID and IVAC_M_uID

Trial status:Study Complete
Study Identifier:
BN_0002-01
ClinicalTrials.gov Identifier:
EudraCT Identifier:
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 SE
Study Complete

Trial details

Medical Condition
  • Breast Cancer
  • Study Drug
  • Biological: IVAC_W_bre1_uID
  • Biological: IVAC_W_bre1_uID/IVAC_M_uID
  • Phase
    Phase 1
    Sex
    Female
    Age
    18+
    Estimated Trial Date
    Oct 2016 - May 2020

    Protocol summary

    The Mutanome Engineered RNA Immuno-Therapy (MERIT) study introduces a novel concept for Individualized Cancer Immunotherapy (IVAC®) to treat each patient with the relevant and immunogenic RNA vaccines for a given patient's tumor. The TNBC-MERIT trial uses two complementary strategies, the WAREHOUSE and the IVAC® MUTANOME concept, resulting in two custom-made IVAC® investigational medicinal products (IMPs) (IVAC_W_bre1_uID and IVAC_M_uID) for each individual patient.

    Trial locations

    Location
    Status
    Location
    Johannes Gutenberg University
    Mainz, RLP, Germany, 55131
    Status
    Location
    National Center for Tumor Diseases (NCT)
    Heidelberg, Germany, 69120
    Status
    Location
    Dr. Horst Schmidt-Kliniken Wiesbaden
    Wiesbaden, Germany, 65199
    Status
    Location
    Uppsala University Hospital
    Uppsala, Sweden, 75185
    Status