M.D. Anderson Cancer Center
This phase I trial studies the side effects and best way to give personalized peptide vaccine in patients with pancreatic or colorectal cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Personalized peptide vaccine is a vaccine developed from patient's own tumor cells and blood in order to use as a biological therapy. Biological therapies, such as personalized peptide vaccine may attack tumor cells and stop them from growing or kill them.
PRIMARY OBJECTIVES: I. Demonstrate that developing a custom vaccine for metastatic pancreatic ductal adenocarcinoma (PDA) and colorectal cancer (CRC) patients is feasible. (cohorts A and B) II. Show that a custom peptide-based vaccine in combination with imiquiomod, pembrolizumab, and/or sotigalimab (APX005M) is safe. (cohorts A and B and C and D) SECONDARY OBJECTIVES: I. Determine the clinical benefit of the peptide vaccine alone or combined with pembrolizumab or pembrolizumab and APX005M. (cohorts A and B and C and D) II. Demonstrate the antigenicity of each vaccine. (cohorts A and B an…
Inclusion Criteria: * Metastatic CRC or PDA planned to or have undergone complete surgical resection (metastatectomy) and also for PDA participants with localized disease planned for primary tumor resection. * Any lines (including zero) of therapy prior to tissue harvest. * Adequate tumor tissue availability * Adults (age ≥ 18) * ECOG PS 0-1 * Life expectancy \>12 months for Cohort C and \>9 months for Cohort D * Adequate organ and marrow function * Ability to understand and the willingness to sign a written informed consent document. * As the effects of a peptide based vaccine, pembrolizumab…
Applied topically
Given IV
Given IV
Given SC
Undergo CT
Undergo MRI
Arctuva estimate
Verify or correct the compensation shown for this listing.