Onkologisches Zentrum Krankenhaus Nordwest Steinbacher Hohl 2-26 60488 Frankfurt am Main DeutschlandRekrutierend» Google-MapsNational Center for Tumor Diseases Heidelberg (Baden-Württemberg) GermanyRekrutierend» Google-MapsViszeralonkologisches Zentrum Universitätsklinikum Tübingen Hoppe-Seyler-Straße 3 72076 Tübingen DeutschlandRekrutierend» Google-Maps
1. Measurement of Safety and tolerability indexes (Incidence of TEAEs, SAEs and DLTs as assessed by CTCAE version 5.0 and changes in assessed safety parameters) for PeptiCRAd-1 monotherapy. (Time Frame - From study protocol day 1 (baseline) until 1 month): The incidence and characteristics of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and dose-limiting toxicities (DLTs) will be assessed by CTCAE version 5.0 and changes from baseline in assessed safety parameters (Hematology tests, Clinical Chemistry safety tests, urine analysis ECOG/WHO performance status, vital signs) are measured in patients receiving PeptiCRAd-1 monotherapy in order to evaluate the safety and tolerability.
2. Measurement of Safety and tolerability indexes (Incidence of TEAEs, SAEs and DLTs as assessed by CTCAE version 5.0 and changes in assessed safety parameters) for PeptiCRAd-1 and CPI combination. (Time Frame - From first month through study completion, an average of 4.5 months.): The incidence and characteristics of TEAEs, SAEs and DLTs will be assessed by CTCAE version 5.0 and changes from baseline in assessed safety parameters (Hematology tests, Clinical Chemistry safety tests, urine analysis ECOG/WHO performance status, vital signs) are measured in patients receiving PeptiCRAd-1 and CPI combination in order to evaluate the safety and tolerability.
Secondary outcome:
1. Measurement of New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1) and Melanoma-associated antigen 3 (MAGE A3) specific T-cells in peripheral blood. (Time Frame - Change from Baseline through study completion, an average of 5 months.): Presence vs. no presence of cellular immune response.
2. Measurement of NY-ESO-1 and MAGE A3 antibodies in serum. (Time Frame - Change from Baseline to an average of 3,5 months): Presence vs. no presence of humoral response.
3. To determine the number of tumor infiltrating lymphocytes (TILs) in tumor mass. (Time Frame - Change from Baseline to an average of 3 months): Number of TILs in tumor biopsies.
4. To determine objective response rate (ORR). (Time Frame - Change from Baseline through study completion, an average of 5 months.): Objective responses according to RECIST 1.1, iRECIST, itRECIST and PERCIST 1.0.
5. To determine overall survival. (Time Frame - Change from Baseline through study completion, an average of 5 months.): Overall survival presented in Kaplan-Meier plot.
6. Correlation between immune activation in peripheral blood and tumor mass and clinical outcome. (Time Frame - Change from Baseline through study completion, an average of 5 months.): Correlation between immune activation (immunological variables) in peripheral blood and tumor mass and clinical outcome (ORR, OS).