Trial document




This trial has been registered retrospectively.
drksid header

  DRKS00011790

Trial Description

start of 1:1-Block title

Title

Identification of individual cancer mutations and analysis of their immunogenicity

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

RB_T002

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

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.
The increase in the number of patients and the extension of the duration by 2 years were applied in an amendment by the Ethics Commission (EC) Mainz and was approved with a positive vote on 17.10.19. After approval, the amendment was also submitted to all other participating ECs which also agreed to the changes.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00011790
  •   2017/04/06
  •   [---]*
  •   no
  •   Approved
  •   837.309.12 (8410-F), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   cancer
  •   C00-C97 -  Malignant neoplasms
end of 1:N-Block indications
start of 1:N-Block interventions

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.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

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.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

[---]*

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2012/10/16
  •   800
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • BioNTech RNA Pharmaceuticals GmbH
    • An der Goldgrube 12
    • 55131  Mainz
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • BioNTech SE
    • Ms.  Alexandra  Kemmer-Brueck 
    • An der Goldgrube 12
    • 55131  Mainz
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Ms.  PD Dr.  Carmen  Loquai 
    • Langenbeckstr. 1
    • 55131  Mainz
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • BioNTech RNA Pharmaceuticals GmbH
    • An der Goldgrube 12
    • 55131  Mainz
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.