Trials / Completed
CompletedNCT03595228
BN Brachyury and Radiation in Chordoma
A Phase 2 Trial of BN-Brachyury and Radiation Therapy in Patients With Advanced Chordoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- Bavarian Nordic · Industry
- Sex
- All
- Age
- 12 Years – 99 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | BN-Brachyury plus radiation | MVA-BN-Brachyury injections will be given on day 0 and 14. FPV-Brachyury injection will be given on day 28, followed by radiation on days 42 through approximately day 70. FPV-Brachyury will then be given two weeks after radiation then every 6-12 weeks through 110 weeks after radiation is complete. |
Timeline
- Start date
- 2018-10-31
- Primary completion
- 2021-12-10
- Completion
- 2022-01-25
- First posted
- 2018-07-23
- Last updated
- 2023-04-14
- Results posted
- 2023-04-14
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03595228. Inclusion in this directory is not an endorsement.