Peptide-Based Immunization for Colon- and Pancreas-Carcinoma (PiCoP-GLOBAL)

Standard of care treatment for colon and pancreas cancer is stage dependent and includes surgical, chemotherapeutic, and radiation therapy. However, since the prognosis of advanced colon cancer and pancreas tumors, in general, is very poor, there is an urgent need for improved treatment.

The enhancement of the immune response via vaccination is among new therapeutic options by using either cell-specific antigens, over-expressed tumor-specific antigens, or mutated tumor-specific antigens (neoepitopes). The biggest potential for high specificity but presuppose an extensive characterization of the respective tumor lies with mutated tumor-specific antigens. In order to identify a neoepitope-based vaccination approach for patient-individualized treatment options, the molecular characteristics of tumors have to first be analyzed.

• Study participants will have access to medical reports with somatic mutations related to the cancer diagnosis via their physicians
• In case neo-antigens that are suitable for the production of patient individual vaccines are found, enrollment in the follow up clinical study is possible

All patients participating in PiCoP-GLOBAL will be making an important contribution to the understanding of colon and pancreatic tumors, and to the potential development of individualized treatment options.

Participants fulfilling the inclusion criteria will be enrolled in the study after providing informed consent. At the time of standard-of-care surgery to remove the tumor, all participants will have a research blood sample drawn. From the tissue removed during surgical treatment, a tumor sample and a control tissue sample will be obtained for the study.

Additional blood samples may be taken at different time points.

All materials are sent to CENTOGENE and analyzed in CENTOGENE’s laboratory in Germany.

The samples will be tested genetically for tumor-associated mutations and MS/MS-based for neoepitopes and for biomarker studies. The collected data will be used in a multi-omics approach to predict neoepitopes.

Follow-up blood samples will be tested genetically and through specific immune monitoring to verify a pre-existing immune response against neoantigens in non-vaccinated patients, to monitor the patients’ immune response during chemotherapy and to monitor the patients’ response to treatment.

Any patients in which promising neoantigens for vaccine production are found may be offered participation in a future clinical study.