Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer

Summary

Participation Requirements

Description

PRIMARY OBJECTIVES: I. Demonstrate that developing a custom vaccine for metastatic pancreatic ductal adenocarcinoma (PDA) and colorectal cancer (CRC) patients is feasible. II. Show that a custom peptide-based vaccine in combination with pembrolizumab is safe. SECONDARY OBJECTIVES: I. Determine preli...

PRIMARY OBJECTIVES: I. Demonstrate that developing a custom vaccine for metastatic pancreatic ductal adenocarcinoma (PDA) and colorectal cancer (CRC) patients is feasible. II. Show that a custom peptide-based vaccine in combination with pembrolizumab is safe. SECONDARY OBJECTIVES: I. Determine preliminary clinical efficacy. II. Demonstrate the antigenicity of each vaccine. OUTLINE: Patients receive personalized synthetic tumor-associated peptide vaccine therapy subcutaneously (SC) on day 1 of weeks 0, 1, 3, 4 and 6, then every 3 weeks until week 30, then at weeks 39 and 51. Beginning 30 minutes after each vaccine is administered, patients then receive imiquimod cream topically after 30 minutes. Patients also receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Courses with pembrolizumab repeat every 3 weeks until week 51 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up 2 times in 6 months.

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