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BN Brachyury and Radiation in Chordoma

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ClinicalTrials.gov Identifier: NCT03595228
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Bavarian Nordic

Brief Summary:
This 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 or disease Intervention/treatment Phase
Chordoma Biological: BN-Brachyury plus radiation Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
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
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Clinically Meaningful Objective Response Rate [ Time Frame: 29 month ]
    Objective response rate anytime within 12 months post completion of radiation on target lesion(s) based on RECIST 1.1



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Ages Eligible for Study:   12 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Christopher Heery, MD 984 243 ext 5000 info@bavarian-nordic.com

Locations
United States, Massachusetts
Massachusetts General Hospital, Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Barbara Anderson, RN, MSN    617-643-2427      
Principal Investigator: Gregory Cote, MD         
Sponsors and Collaborators
Bavarian Nordic
Investigators
Principal Investigator: Gregory Cote, MD Massachusetts General Hospital

Responsible Party: Bavarian Nordic
ClinicalTrials.gov Identifier: NCT03595228     History of Changes
Other Study ID Numbers: BRACHY-CHOR-001
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Chordoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms