Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps

Summary

This randomized phase II clinical trial studies how well MUC1 peptide-poly-ICLC adjuvant vaccine works in treating patients with newly diagnosed advanced colon polyps (adenomatous polyps). Adenomatous polyps are growths in the colon that may develop into colorectal cancer over time. Vaccines made from peptides may help the body build an effective immune response to kill polyp cells. MUC1 peptide-poly-ICLC adjuvant vaccine may also prevent the recurrence of adenomatous polyps and may prevent the development of colorectal cancer.

Timeline

Start

2014-06-23

Primary completion

2017-01-27

Completion

2027-03-09

Outcome

Met primary endpoint

registry analysis (superiority test); Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) vs Arm II (Placebo); p = 0.0004; Wilcoxon (Mann-Whitney) NCT02134925 ↗

Drugs

Indications