BN Brachyury and Radiation in Chordoma
Active, not recruiting
Sponsor: Bavarian Nordic
Collaborators:
Information provided by (Responsible party):
Sponsor
ClinicalTrials.gov Identifier: NCT03595228
Protocol Info
Short Description: |
BN-Brachyury + Radiation in Advanced Chordoma |
Long Description: |
A Phase 2 trial of BN-Brachyury and radiation therapy in patients with advanced chordoma |
MGH Status: |
Open |
Sponsor: |
Bavarian Nordic |
Disease Program: |
Sarcoma |
Next Steps
If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.
Purpose
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 will be needed to
proceed to stage 2.
Condition Title |
Intervention |
Phase |
Chordoma
|
BN-Brachyury plus radiation
|
Phase 2 |
Study Type |
Interventional |
Official Title |
A Phase 2 Trial of BN-Brachyury and Radiation Therapy in Patients With Advanced Chordoma |
Primary Outcome Measures
Clinically Meaningful Objective Response Rate [Time Frame: 27 months] [Designated as safety issue: ]
Secondary Outcome Measures
Safety of BN-Brachyury: adverse events [Time Frame: 42 months] [Designated as safety issue: ]
Clinical Benefit of BN-Brachyury plus radiation therapy [Time Frame: 42 months] [Designated as safety issue: ]
Estimated Enrollment: |
29 |
Study Start Date: |
October 2018 |
Estimated Study Completion Date: |
April 2022 |
Estimated Primary Completion Date: |
January 2021 |
Arms |
Assigned Interventions |
Experimental:BN-Brachyury plus radiation
MVA-BN-Brachyury then treatment of the tumor(s) with radiation followed by FPV-Brachyury
|
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. |
Eligibility
Ages Eligible for Study: 99 Years-99 Years
Genders Eligible for Study: All
Accepts Healthly 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.
More Information
No publications provided
Responsible Party: |
Sponsor
|
ClinicalTrials.gov Identifier: |
NCT03595228 |
Other Study ID Numbers: |
|
Study First Received: |
|
Last Updated: |
|
Health Authority: |
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Additional relevant MeSH terms:
Chordoma
Next Steps
If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.
ClinicalTrials.gov processed this data on February 25, 2021