Patients with unresectable, previously treated locally advanced or metastatic colorectal carcinoma.
Conditions
Brief summary
The primary endpoint includes safety and tolerability of EO4010 in combination with nivolumab, and/or with bevacizumab by a descriptive medical assessment of the combined profile of incidences of adverse events (AEs), treatment-emergent AEs (TEAEs), serious AEs (SAEs), deaths, reasons for treatment discontinuation/delays, and laboratory abnormalities using the NCI-CTCAE v5.0 grading system.
Detailed description
percentage of patients with shown immunogenicity (expansion of specific T cells comparing samples taken at baseline versus on treatment in an individual patient determining if the patient has a positive response to the immunization, or not) in relation to each peptide composing EO4010 by interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot), and by intracellular cytokines staining, or multimers staining assays., Cross-reactivities with the human TAAs., ORR, DCR, TTR, DOR and, PFS as described by RECIST 1.1 and iRECIST criteria., OS
Interventions
DRUGEO4010
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
Sponsors
Enterome
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint includes safety and tolerability of EO4010 in combination with nivolumab, and/or with bevacizumab by a descriptive medical assessment of the combined profile of incidences of adverse events (AEs), treatment-emergent AEs (TEAEs), serious AEs (SAEs), deaths, reasons for treatment discontinuation/delays, and laboratory abnormalities using the NCI-CTCAE v5.0 grading system. | — |
Secondary
| Measure | Time frame |
|---|---|
| percentage of patients with shown immunogenicity (expansion of specific T cells comparing samples taken at baseline versus on treatment in an individual patient determining if the patient has a positive response to the immunization, or not) in relation to each peptide composing EO4010 by interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot), and by intracellular cytokines staining, or multimers staining assays., Cross-reactivities with the human TAAs., ORR, DCR, TTR, DOR and, PFS as described by RECIST 1.1 and iRECIST criteria., OS | — |
Countries
France, Spain
Outcome results
None listed