CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
BN-Brachyury plus radiationbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03595228
NCT03595228Phase 2Completed
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A Phase 2 Trial of BN-Brachyury and Radiation Therapy in Patients With Advanced Chordoma

Bavarian Nordic·interventional·Posted Jul 23, 2018·Updated Apr 14, 2023

In Brief

A Phase 2 clinical trial evaluating BN-Brachyury plus radiation for Chordoma. Completed, enrolled 29 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChordoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJul 23, 2018
Enrollment StartOct 31, 2018
Primary CompletionDec 10, 2021
Study CompletionJan 25, 2022
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 7.9 years ago

Interventions

BN-Brachyury plus radiationbiological

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.