NCT02179515 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Fernando RI, Litzinger M, Trono P, Hamilton DH, Schlom J, Palena C
The T-box transcription factor Brachyury promotes epithelial-mesenchymal transition in human tumor cells. J Clin Invest. 2010 Feb;120(2):533-44. doi: 10.1172/JCI38379. Epub 2010 Jan 11.
Heery CR, Palena C, McMahon S, Donahue RN, Lepone LM, Grenga I, Dirmeier U, Cordes L, Marté J, Dahut W, Singh H, Madan RA, Fernando RI, Hamilton DH, Schlom J, Gulley JL
Phase I Study of a Poxviral TRICOM-Based Vaccine Directed Against the Transcription Factor Brachyury. Clin Cancer Res. 2017 Nov 15;23(22):6833-6845. doi: 10.1158/1078-0432.CCR-17-1087. Epub 2017 Aug 30.
Hodge JW, Sabzevari H, Yafal AG, Gritz L, Lorenz MG, Schlom J
A triad of costimulatory molecules synergize to amplify T-cell activation. Cancer Res. 1999 Nov 15;59(22):5800-7.

An Open Label Phase I Study to Evaluate the Safety and Tolerability of a Modified Vaccinia Ankara (MVA) Based Vaccine Modified to Express Brachyury and T-Cell Costimulatory Molecules (MVA Brachyury-TRICOM)

Details for clinical trial NCT02179515

Clinical trial NCT02179515 - References