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NCT03595228 · ClinicalTrials.gov registry record · Phase 2
BN Brachyury and Radiation in Chordoma
A Phase 2 study, sponsored by Bavarian Nordic.
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
NCT03595228: Completed Phase 2 study, sponsored by Bavarian Nordic.
NCT03595228 is a Phase 2 study that has completed, run by Bavarian Nordic. The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03595228, a Phase 2 study, has completed, sponsored by Bavarian Nordic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
Study Summary
The goal of this study is to determine if the combination of BN-Brachyury plus radiation therapy can induce objective radiographic response rate (ORR) in patients, using a Simon 2-stage optimal design. In stage 1, a minimum of threshold of activity is needed to proceed to stage 2.
Primary Outcome
Rate of subjects achieving a best response of either Complete Response or Partial Response per modified RECIST v1.1. A modified RECIST v1.1 assessment is based on targeted radiated lesion(s). Progression of a non-target lesion does not result in disease progression by the modified RECIST evaluation for this trial. Assessment for targeted radiated lesion(s): Complete Response (CR)=Disappearance of all target radiated lesions; Partial Response (PR)= \>=30% decrease in the sum of the longest diamet
Interventions
- BIOLOGICAL BN-Brachyury plus radiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2018-10-31 |
| Est. Completion | 2022-01-25 |
| Phase | Phase 2 |
What the finished NCT03595228 record still lists
NCT03595228 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which BN-Brachyury plus radiation is the first listed.
NCT03595228 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03595228 about?
NCT03595228 is a clinical study titled "BN Brachyury and Radiation in Chordoma". The goal of this study is to determine if the combination of BN-Brachyury plus radiation therapy can induce objective radiographic response rate (ORR) in patients, using a Simon 2-stage optimal design. In stage 1, a minimum of threshold of activity is needed to proceed to stage 2.
What is the current status of trial NCT03595228?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2018-10-31. Estimated completion is 2022-01-25.
What interventions are being tested in trial NCT03595228?
The interventions under investigation include: BN-Brachyury plus radiation (BIOLOGICAL).
Who is sponsoring clinical trial NCT03595228?
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 NCT03595228's enrollment target sits among peer trials
29 1669th of 2000 higher than 324 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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