Trial document




This trial has been registered retrospectively.
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  DRKS00011790

Trial Description

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Title

Identification of individual cancer mutations and analysis of their immunogenicity

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Trial Acronym

RB_T002

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URL of the Trial

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Brief Summary in Lay Language

This research project is conducted by BioNTech RNA Pharmaceuticals GmbH (part of BioNTech Group), a young biotechnology company developing immunotherapies for cancer treatment and with several ongoing clinical trials in this field. The immunotherapeutic treatments against cancer are based on the increasing knowledge on the role of the immune system in fighting cancer and exploit immune functions for anticancer treatment. The described research project aims at answering several research questions with the same overall goal: improve available treatment modalities and develop new treatment options.
Within the framework of this research project, samples from patients with malignant diseases will be analyzed (mainly tissue and blood samples) via histological, genetic and immunological methods. Full age and underage cancer patients as well as healthy volunteers can be enrolled in the research project. However, recruitment of underage cancer patients and healthy volunteers is solely performed in specialized centers and is therefore not further elucidated here. Patients participating in this research project will receive the standard-of-care treatment for their disease. This research project has no therapeutic character; therefore, patients who participate in this research project will not receive any investigational medicinal product.
On November 28th 2018, an amendment was submitted to the ethics committee (EC) in Mainz to increase the number of participants. After approval, the amendment was also submitted to all other participating ECs which also agreed to the changes.

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Brief Summary in Scientific Language

BioNTech RNA Pharmaceuticals GmbH develops individualized RNA-based vaccines, which draw the attention of the immune system to genetic alterations in the tumor. Thus, these vaccines support the body’s defenses against tumor cells. The aim of this research project is to gain a profound understanding of genetic alterations within tumors as well as the tumor immunology of several entities and to use this knowledge for further development of individualized cancer immunotherapies.

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Organizational Data

  •   DRKS00011790
  •   2017/04/06
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  •   no
  •   Approved
  •   837.309.12 (8410-F), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

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Health Condition or Problem studied

  •   cancer
  •   C00-C97 -  Malignant neoplasms
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Interventions/Observational Groups

  •   Within the framework of this research project, samples from patients with malignant diseases will be analyzed (mainly tissue and blood samples) via histological, genetic and immunological methods.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The aim of this research project is to gain a profound understanding of genetic alterations within tumors as well as the tumor immunology of several entities (via histological, genetic and immunological analysis of tissue and blood samples) and to use this knowledge for further development of individualized cancer immunotherapies.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2012/10/16
  •   650
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

signed informed consent; Health condition, that allows planned interventions (according clinical standards);
Hemoglobin value ≥ 10,0 g / dl;
Patient with suspected/confirmed malign tumor with either already excised/planned excision of tumor material and/or possibility of tumor biopsies exclusively taken for the research project

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Exclusion Criteria

Known pregnancy or breastfeeding;
Known acute or chronically active hepatitis infection, known HIV infection;
Patients who are incapable to give consent or are not able to understand the nature of the project;
serious concomitant disease or other circumstances (e.g. psychological, familial, sociological or geographical circumstances), which do not allow an adequate participation

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Addresses

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    • BioNTech RNA Pharmaceuticals GmbH
    • An der Goldgrube 12
    • 55131  Mainz
    • Germany
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    • BioNTech AG
    • Ms.  Alexandra  Kemmer-Brueck 
    • An der Goldgrube 12
    • 55131  Mainz
    • Germany
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    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Ms.  PD Dr.  Carmen  Loquai 
    • Langenbeckstr. 1
    • 55131  Mainz
    • Germany
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Sources of Monetary or Material Support

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    • BioNTech RNA Pharmaceuticals GmbH
    • An der Goldgrube 12
    • 55131  Mainz
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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