ChordomaPhase 2NCT03595228

BN Brachyury and Radiation in Chordoma

A Phase 2 study testing BN-Brachyury plus radiation in people with Chordoma, run by Bavarian Nordic at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 12 to 99 years
Conditions the study is for: Chordoma
What is being tested?: BN-Brachyury plus radiation
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 5 sitesUnited States
Study dates: 31 Oct 2018to 25 Jan 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 99 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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.

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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.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Massachusetts General Hospital, Cancer Center
Boston, Massachusetts, 02114
MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic, Florida
Jacksonville, Florida, 32224
Mayo Clinic, Arizona
Phoenix, Arizona, 85054
Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase 2 Trial of BN-Brachyury and Radiation Therapy in Patients With Advanced Chordoma

Conditions: Chordoma
Being tested: BN-Brachyury plus radiation
Medical subject headings: Chordoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT03595228
Study group	Role	What they receive
BN-Brachyury plus radiation	Experimental	BN-Brachyury as both MVA and FPV are given before radiation, and followed by FPV-Brachyury Receives: Biological: BN-Brachyury plus radiation

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective Response Rate (ORR)
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 diameter of target radiated lesions; Progressive Disease (PD) = >=20% increase in the sum of the longest diameter of target radiated lesions, Stable Disease (SD)=-30%<sum of the longest diameter of target radiated lesions<20%.
Measured: Within 12 months post-completion of radiation on target lesion(s) based on modified RECIST v1.1

Secondary outcomes (3)

Progression-free Survival (PFS)
Kaplan-Meier of the time interval from first treatment to objective tumor progression based on modified RECIST v1.1 or death. A modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) based on targeted radiated lesion(s) will be used. Progression will be defined as a 20% increase in the sum of the longest diameter of target radiated lesions in this trial, and a progression of a non-target lesion does not result in disease progression by the modified RECIST evaluation used for this trial.
Measured: Time from the day of first treatment to the start of disease progression or death, whichever occurs first up to 30 days after last tumor assessment visit. Data were collected up to 29 months.
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Best Observed Scores
Pain intensity and pain interference scores are summarized. Pain intensity scores includes pain items "Worst Pain in the Last Week", "Least Pain in the Last Week", and "Average Pain in the Last Week" and "Pain Right Now". Composite pain severity score (a mean severity score of the four pain items listed before). Composite pain interference score (a mean of the seven interference items). This will be calculated if at least four of the seven interference items have been completed on a given administration. Pain scores range from 0 to 10 with a score of 10 is the worst pain imaginable and a score of 0 is no pain. Best observed scores is the lowest score value observed.
Measured: Overall Treatment Period: The time from the day of first treatment to the last scheduled trial visit, approximately 30 days after the last treatment visit. Data were collected up to 29 months.
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Worst Observed Scores
Pain intensity and pain interference scores are summarized. Pain intensity scores includes pain items "Worst Pain in the Last Week", "Least Pain in the Last Week", and "Average Pain in the Last Week" and "Pain Right Now". Composite pain severity score (a mean severity score of the four pain items listed before). Composite pain interference score (a mean of the seven interference items). This will be calculated if at least four of the seven interference items have been completed on a given administration. Pain scores range from 0 to 10 with a score of 10 is the worst pain imaginable and a score of 0 is no pain. Worst observed scores is the highest score value observed.
Measured: Overall Treatment Period: The time from the day of first treatment to the last scheduled trial visit, approximately 30 days after the last treatment visit. Data were collected up to 29 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Oct 201825 Jan 2022

First posted23 Jul 2018
Study start31 Oct 2018
Primary completion10 Dec 2021
Study completion25 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ChordomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03595228
Sponsor's protocol ID: BRACHY-CHOR-001
Status last verified: Mar 2023
First submitted: 12 Jul 2018
Last updated: 14 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Wedekind MF, Widemann BC, Cote G. Chordoma: Current status, problems, and future directions. Curr Probl Cancer. 2021 Aug;45(4):100771. doi: 10.1016/j.currproblcancer.2021.100771. Epub 2021 Jul 1.
PubMed 34266694

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chordoma trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Trial of BN-Brachyury and Radiation Therapy in Patients With Advanced Chordoma
ClinicalTrials.gov ID: NCT03595228
Acronym / sponsor ID: BRACHY-CHOR-001
Conditions: Chordoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Bavarian NordicIndustry (pharma, biotech, devices)
Study start: 31 Oct 2018 (actual)
Primary completion: 10 Dec 2021 (actual)
Study completion: 25 Jan 2022 (actual)
First posted: 23 Jul 2018 (actual)
Results: Posted 14 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BN-Brachyury plus radiation	Experimental	Biological: BN-Brachyury plus radiationBN-Brachyury as both MVA and FPV are given before radiation, and followed by FPV-Brachyury

Who may qualify

Ages: 12 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BN-Brachyury plus radiationMVA-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.	Biological	BN-Brachyury plus radiation

Primary outcome

Objective Response Rate (ORR)
Time frame: Within 12 months post-completion of radiation on target lesion(s) based on modified RECIST v1.1
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 diameter of target radiated lesions; Progressive Disease (PD) = >=20% increase in the sum of the longest diameter of target radiated lesions, Stable Disease (SD)=-30%<sum of the longest diameter of target radiated lesions<20%.

3 secondary outcomes

Progression-free Survival (PFS)
Time frame: Time from the day of first treatment to the start of disease progression or death, whichever occurs first up to 30 days after last tumor assessment visit. Data were collected up to 29 months.
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Best Observed Scores
Time frame: Overall Treatment Period: The time from the day of first treatment to the last scheduled trial visit, approximately 30 days after the last treatment visit. Data were collected up to 29 months.
Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Worst Observed Scores
Time frame: Overall Treatment Period: The time from the day of first treatment to the last scheduled trial visit, approximately 30 days after the last treatment visit. Data were collected up to 29 months.

Results and safety

Results posted to the registry on 14 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BN-Brachyury Plus Radiation	29	10

Primary outcome: Objective Response Rate (ORR)

Time frame: Within 12 months post-completion of radiation on target lesion(s) based on modified RECIST v1.1. Number (90% Confidence Interval). Unit: percentage of subjects with OR

Measure	BN-Brachyury Plus Radiation n = 26
Value	7.7 (2.6 to 20.8)

Population analysed: Evaluable Analysis Set conisits of subjects who have completed two prime doses of MVA-BN-Brachyury and one booster dose of FPV-Brachyury prior to radiation, have completed radiation therapy, have at least 3 out of 4 booster doses of FPV-Brachyury in 14 weeks after radation, have both baseline and at least one post-baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan for objective tumor evaluation.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: All Serious adverse events that are presented during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BN-Brachyury Plus Radiation	8 of 29 (27.6%)	29 of 29 (100%)	2 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34266694Wedekind MF, Widemann BC, Cote G. Chordoma: Current status, problems, and future directions. Curr Probl Cancer. 2021 Aug;45(4):100771. doi: 10.1016/j.currproblcancer.2021.100771. Epub 2021 Jul 1.
Individual participant dataSharing planned: No

Related trials for Chordoma

Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
RecruitingObservational study
Children and Adults With Chordoma
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Active, not recruitingObservational study
Genetic Clues to Chordoma Etiology: A Protocol to Identify Sporadic Chordoma Patients for Studies of Cancer-Susceptibility Genes
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RecruitingObservational study
Exploration of Personalized Biomarkers During Neoadjuvant Radiation Therapy for Spinal and Sacral Chordoma
Chordoma of Spine, Chordoma of Skull Base
Active, not recruiting
High Dose Intensity Modulated Proton Radiation Treatment +/- Surgical Resection of Sarcomas of the Spine, Sacrum and Base of Skull
Chordoma of Spine, Chordoma of Sacrum

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gregory Cote, MD principal investigator

Massachusetts General Hospital

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BN-Brachyury plus radiation in people with Chordoma, run by Bavarian Nordic at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Within 12 months post-completion of radiation on target lesion(s) based on modified RECIST v1.1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03595228, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.