The purpose of this study is to determine the immunogenicity of the CIMAvaxEGF® vaccine (that is, its effectiveness in inducing an anti-tumor immune response) in patients with metastatic KRAS/NRAS/BRAF wild-type gene colorectal cancer, when given in combination with standard therapies used in the treatment of advanced colorectal cancer.
Primary Objective \- Determine the immunogenicity of CIMAvax in patients with metastatic, KRAS/NRAS/BRAF wild type CRC in combination with Chemotherapy plus appropriate biologic agent in 1st or 2nd/3rd line setting and chemotherapy plus anti-EGFR therapy in 2nd/3rd line setting.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Immunogencity of vaccine
Percentage of patients with antibody titers greater than or equal to 1:4000 using a 90% confidence interval obtained by Jeffery's prior method
Time frame: up to 60 days after last dose
Progression free survival
Time frame: time from treatment until disease progression, death or last follow up assesed up to 2 years
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Given IV
Given IV
Given IV
Given IV
Undergo metastasectomy
Undergo collection of blood samples
Undergo CT
Given IV