NCT03349983

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

An Open-label Phase 1 Trial to Evaluate the Safety and Tolerability of a Modified Vaccinia Ankara (MVA) Priming Followed by Fowlpox Booster Vaccines Modified to Express Brachyury and T-cell Costimulatory Molecules (MVA-BN-Brachyury/FPV-Brachyury)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Bavarian Nordic · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Safety Issues

Interventions

Type	Name	Description
BIOLOGICAL	MVA-BN-Brachyury/ FPV-Brachyury	Two priming doses of MVA-BN-Brachyury followed by boost doses of FPV-Brachyury monthly for 6 months

Timeline

• Start date: 2018-01-08
• Primary completion: 2020-06-13
• Completion: 2020-06-13
• First posted: 2017-11-22
• Last updated: 2020-08-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study