Trial document
This trial has been registered retrospectively.
DRKS00011790
Trial Description
Title
Identification of individual cancer mutations and analysis of their immunogenicity
Trial Acronym
RB_T002
URL of the Trial
[---]*
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.
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.
Do you plan to share individual participant data with other researchers?
[---]*
Description IPD sharing plan:
[---]*
Organizational Data
- DRKS00011790
- 2017/04/06
- [---]*
- no
- Approved
- 837.309.12 (8410-F), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
Secondary IDs
- [---]*
Health Condition or Problem studied
- cancer
- C00-C97 - Malignant neoplasms
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.
Characteristics
- Interventional
- [---]*
- Single arm study
- Open (masking not used)
- [---]*
- Uncontrolled/Single arm
- Other
- Single (group)
- N/A
- N/A
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.
Secondary Outcome
[---]*
Countries of Recruitment
- Germany
Locations of Recruitment
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
Recruitment
- Actual
- 2012/10/16
- 800
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- no minimum age
- no maximum age
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
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
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-sponsorstart 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-contactstart of 1:1-Block address contact scientific-contact- 0613190840
- [---]*
- info at biontech.de
- [---]*
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-contactstart of 1:1-Block address contact public-contact- 06131 17-0
- [---]*
- carmen.loquai at unimedizin-mainz.de
- [---]*
end of 1:1-Block address contact public-contact
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 materialSupportstart of 1:1-Block address contact materialSupport- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
- [---]*
Trial Publications, Results and other Documents
- [---]*