Clinical Trial - NCT03595228

BN Brachyury and Radiation in Chordoma

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


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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: 29 month] [Designated as safety issue: ]


Secondary Outcome Measures

Estimated Enrollment: 29
Study Start Date: October 2018
Estimated Study Completion Date: January 2021
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03595228

Locations

  • 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, Minnesota
    • Mayo Clinic Rochester, Minnesota, United States, 55902

Sponsors and Collaborators

Bavarian Nordic

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03595228
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

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 July 18, 2019