Safety and Tolerability Trial (MVA-BN-Brachyury/FPV-Brachyury)

Phase 1 Completed 11 enrolled Bavarian Nordic

NaSequentialOpen-labelTreatment

Summary

An open-label Phase 1 trial to evaluate the safety and tolerability of MVA-BN-Brachyury priming and FPV-Brachyury boost vaccines modified to express brachyury and T-cell costimulatory molecules in patients with a metastatic or unresectable locally advanced malignant solid tumor. Subjects will be given the following subcutaneous doses: two prime doses with MVA-BN-Brachyury and monthly boost doses with FPV-Brachyury for 6 months. The study will last approximately 104 weeks before starting long term follow up (FU).

Timeline

Start: 2018-01-08
Primary completion: 2020-06-13
Completion: 2020-06-13

Publications

Results Collins JM, Donahue RN, Tsai YT, Manu M, Palena C, Gatti-Mays ME, Marte JL, Madan RA, Karzai F, Heery CR, Strauss J, Abdul-Sater H, Cordes L, Schlom J, Gulley JL, Bilusic M. Phase I Trial of a Modified Vaccinia Ankara Priming Vaccine Followed by a Fowlpox Virus Boosting Vaccine Modified to Express Brachyury and Costimulatory Molecules in Advanced Solid Tumors. Oncologist. 2020 Jul;25(7):560-e1006. doi: 10.1634/theoncologist.2019-0932. Epub 2019 Dec 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	FPV-Brachyury	Vaccine	1e+09 iu	Subcutaneous
Subject	MVA-BN-Brachyury	Vaccine	8e+08 iu	Subcutaneous

Indications

No indication recorded.