BN Brachyury and Radiation in Chordoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03595228 |
Recruitment Status :
Completed
First Posted : July 23, 2018
Last Update Posted : February 28, 2022
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Condition or disease | Intervention/treatment | Phase |
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Chordoma | Biological: BN-Brachyury plus radiation | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Trial of BN-Brachyury and Radiation Therapy in Patients With Advanced Chordoma |
Actual Study Start Date : | October 31, 2018 |
Actual Primary Completion Date : | December 10, 2021 |
Actual Study Completion Date : | January 25, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: BN-Brachyury plus radiation
MVA-BN-Brachyury then treatment of the tumor(s) with radiation followed by FPV-Brachyury
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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. |
- Clinically Meaningful Objective Response Rate [ Time Frame: 27 months ]Objective response rate anytime within 12 months post completion of radiation on target lesion(s) based on RECIST 1.1
- Safety of BN-Brachyury: adverse events [ Time Frame: 42 months ]Incidence of treatment-emergent adverse events
- Clinical Benefit of BN-Brachyury plus radiation therapy [ Time Frame: 42 months ]Evaluate other clinical endpoints that might be indicative of clinical benefits (PFS, improvement of other clinical symptoms)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years to 99 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must have histologically confirmed chordoma
- Patients must have measurable disease by RECIST 1.1
- Patients must be scheduled to have radiation therapy to at least 1 target lesion.
- Age ≥12 years
- Patients must have normal organ and marrow function
- Must have recovered completely from any reversible toxicity associated with recent therapy.
- There should be a minimum of 2 weeks from any chemotherapy, small molecule/targeted therapy, immunotherapy and/or radiation prior to enrolment
- Females of childbearing potential and male partners of Females of childbearing potential must agree to use effective birth control or abstinence from screening to after the last vaccination therapy
Exclusion Criteria:
- Concurrent treatment for cancer, with specific exceptions noted in the inclusion criteria
- Chronic hepatitis B or C infection.
- Any significant disease, that in the opinion of the investigator may impair the patient's tolerance of trial treatment.
- Significant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding, or rendering of informed consent.
- Active autoimmune diseases requiring treatment or a history of autoimmune disease that might be stimulated by vaccine treatment. This requirement is due to the potential risks of exacerbating autoimmunity.
- Concurrent use of systemic steroids, except for physiological doses of systemic steroid replacement or local steroid use.
- Patients who are receiving any other investigational agents within 28 days before start of trial treatment.
- History of allergic reactions attributed to compounds of similar chemical or biological composition to MVA-BN/FPV-Brachyury or other agents used in trial. History of allergic reactions to aminoglycoside antibiotic or egg products.
- Serious or uncontrolled intercurrent illness, included but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with trial requirements.
- Pregnant women are excluded from this trial due to the unknown effects of the BN-Brachyury on the fetus or infant.
- HIV-positive patients are ineligible because of the potential for decreased immune response to the vaccine.
- Significant cardiovascular disease, which includes but is not limited to New York Heart Association Heart Failure Class II or greater, myocardial infarction within the previous 3 months, unstable arrhythmias, unstable angina.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03595228
United States, Arizona | |
Mayo Clinic, Arizona | |
Phoenix, Arizona, United States, 85054 | |
United States, Florida | |
Mayo Clinic, Florida | |
Jacksonville, Florida, United States, 32224 | |
United States, Massachusetts | |
Massachusetts General Hospital, Cancer Center | |
Boston, Massachusetts, United States, 02114 | |
United States, Missouri | |
Washington University School of Medicine | |
Saint Louis, Missouri, United States, 63110 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Gregory Cote, MD | Massachusetts General Hospital |
Responsible Party: | Bavarian Nordic |
ClinicalTrials.gov Identifier: | NCT03595228 |
Other Study ID Numbers: |
BRACHY-CHOR-001 |
First Posted: | July 23, 2018 Key Record Dates |
Last Update Posted: | February 28, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Chordoma Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |