Studies
| Study First Submitted Date | 2021-07-23 |
| Study First Posted Date | 2021-08-20 |
| Last Update Posted Date | 2021-09-08 |
| Verification Month Year | July 2021 |
| Verification Date | 2021-07-31 |
| Last Update Posted Date | 2021-09-08 |
Detailed Descriptions
| Sequence: | 20808978 |
| Description | Ethics: Patient treatment will be conducted according to §13 Absatz 2b, AMG. |
Browse Interventions
| Sequence: | 96399261 | Sequence: | 96399262 | Sequence: | 96399263 | Sequence: | 96399264 |
| Mesh Term | Monatide (IMS 3015) | Mesh Term | Adjuvants, Immunologic | Mesh Term | Immunologic Factors | Mesh Term | Physiological Effects of Drugs |
| Downcase Mesh Term | monatide (ims 3015) | Downcase Mesh Term | adjuvants, immunologic | Downcase Mesh Term | immunologic factors | Downcase Mesh Term | physiological effects of drugs |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
| Sequence: | 52394141 |
| Name | Cancer |
| Downcase Name | cancer |
Id Information
| Sequence: | 40317178 |
| Id Source | org_study_id |
| Id Value | InHeVac01 |
Interventions
| Sequence: | 52703787 |
| Intervention Type | Biological |
| Name | Personalized multi-peptide vaccine |
| Description | Peptide vaccine: Personalized multi-peptide vaccine cocktails consisting of 200-300µg each of 5-10 tumor-associated peptides selected individually based on the patient-individual HLA allotypes and HLA ligandome analysis of tumor cells Peptides are synthesized in the GMP-certified Wirkstoffpeptidlabor at the University of Tübingen and will be formulated at the GMP-Center of the University Hospital Tübingen. Peptides will be administered subcutaneously (s.c.) together with the TLR1/2 ligand XS15 emulsified in Montanide ISA 51 VG as adjuvant. Vaccination will take place every 6 weeks. A total of two to five vaccinations are planned. Treatment schedule: Vaccination will take place every 6 weeks. A total of two to five vaccinations are planned, depended on the induction of peptide-specific T-cell responses. |
Sponsors
| Sequence: | 48526692 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | University Hospital Tuebingen |
Overall Officials
| Sequence: | 29401972 |
| Role | Study Chair |
| Name | Helmut R Salih, MD |
| Affiliation | CCU Translational Immunology, University Hospital Tübingen, Germany |
Central Contacts
| Sequence: | 12066337 | Sequence: | 12066338 |
| Contact Type | primary | Contact Type | backup |
| Name | Juliane S Walz, MD | Name | Helmut R Salih, MD |
| Phone | 07071/2968746 | Phone | 07071/2968746 |
| kketi@med.uni-tuebingen.de | kketi@med.uni-tuebingen.de | ||
| Role | Contact | Role | Contact |
Eligibilities
| Sequence: | 30893902 |
| Gender | All |
| Minimum Age | N/A |
| Maximum Age | N/A |
| Criteria | Inclusion Criteria: Documented diagnosis of advanced malignant disease Advanced malignant disease without any available standard of care treatment option Low tumor cell burden Live expectancy > 6 month Ability to understand and voluntarily sign an informed consent form. Ability to adhere to the study visit schedule and other protocol requirements Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2. Exclusion Criteria: Pregnant or lactating females. Treatment regimens inducing sever T cell deficiencies Treatment-related side effect > CTC grade 2 (CTCAE V5.0 Participation in any clinical study or having taken any investigational therapy, which would interfere with the studys primary and secondary end points within 2 weeks prior to vaccination Pre-existing auto-immune disease except for Hashimoto thyroiditis and mild (not requiring immunosuppressive treatment) psoriasis |
| Adult | True |
| Child | True |
| Older Adult | True |
Calculated Values
| Sequence: | 254137819 |
| Registered In Calendar Year | 2021 |
| Were Results Reported | False |
| Has Single Facility | False |
Intervention Other Names
| Sequence: | 26782849 |
| Intervention Id | 52703787 |
| Name | Adjuvants XS15 and Montanide ISA 51 VG |
Links
| Sequence: | 4404889 |
| Url | https://www.medizin.uni-tuebingen.de/en-de/das-klinikum/einrichtungen/kliniken/medizinische-klinik/kke-translationale-immunologie |
| Description | Department CCU Translational Immunology |
Responsible Parties
| Sequence: | 29006242 |
| Responsible Party Type | Sponsor |