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NCT03349983 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability Trial (MVA-BN-Brachyury/FPV-Brachyury)
A Phase 1 study, sponsored by Bavarian Nordic.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT03349983: Completed Phase 1 study, sponsored by Bavarian Nordic.
NCT03349983 is a Phase 1 study that has completed, run by Bavarian Nordic. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03349983, a Phase 1 study, has completed, sponsored by Bavarian Nordic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study 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).
Primary Outcome
Fraction of patients who experience a (Dose Limiting Toxicity) DLT.
Interventions
- BIOLOGICAL MVA-BN-Brachyury/ FPV-Brachyury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-01-08 |
| Est. Completion | 2020-06-13 |
| Phase | Phase 1 |
What the finished NCT03349983 record still lists
NCT03349983 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which MVA-BN-Brachyury/ FPV-Brachyury is the first listed.
NCT03349983 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03349983 about?
NCT03349983 is a clinical study titled "Safety and Tolerability Trial (MVA-BN-Brachyury/FPV-Brachyury)". 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 giv...
What is the current status of trial NCT03349983?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2018-01-08. Estimated completion is 2020-06-13.
What interventions are being tested in trial NCT03349983?
The interventions under investigation include: MVA-BN-Brachyury/ FPV-Brachyury (BIOLOGICAL).
Who is sponsoring clinical trial NCT03349983?
This trial is sponsored by Bavarian Nordic, which has 41 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03349983's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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