drugset / Trial / NCT01720836

Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer

NCT01720836

Phase 1/2 Recruiting 30 enrolled Olivera Finn
Non-randomizedParallel-groupOpen-labelTreatment

Summary

All subjects will receive the vaccine subcutaneously every 3 weeks x 3 with optional yearly booster vaccines up to and including 5 years post last vaccine for those patients who are confirmed responders to the vaccine . The rationale for using Poly-ICLC as an adjuvant are two ongoing trials at University of Pittsburgh Cancer Institute (UPCI) of the MUC1 100mer peptide vaccine - one as a therapeutic vaccine in subjects with metastatic castrate resistant prostate cancer and the other in subjects with advanced colonic adenomas at risk for developing colon cancer. The same formulation, MUC1 100mer peptide admixed with Poly-ICLC, is used in both trials. There has been no toxicity observed and the vaccine is highly immunogenic in early disease. In the proposed NSCLC trial the anti-MUC1 immune response will be thoroughly characterized.

Timeline

Start
2012-11
Primary completion
2027-10
Completion
2032-10

Drugs

EvaluationDrugModalityDoseRoute
Subject MUC1 100mer peptide Peptide 100 ug Subcutaneous
Background Hiltonol Other / unclassified 500 ug Subcutaneous