Personalized Multi-peptide Vaccination in Combination With the TLR1/2 Ligand XS15 in Cancer Patients


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


Sequence: 52394141
Name Cancer
Downcase Name cancer

Id Information

Sequence: 40317178
Id Source org_study_id
Id Value InHeVac01


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.


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
Email Email
Role Contact Role Contact


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


Sequence: 4404889
Description Department CCU Translational Immunology

Responsible Parties

Sequence: 29006242
Responsible Party Type Sponsor