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BN Brachyury and Radiation in Chordoma

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 : Active, not recruiting
First Posted : July 23, 2018
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Bavarian Nordic

Tracking Information
First Submitted Date  ICMJE July 12, 2018
First Posted Date  ICMJE July 23, 2018
Last Update Posted Date August 15, 2019
Actual Study Start Date  ICMJE October 31, 2018
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 12, 2018)
Clinically Meaningful Objective Response Rate [ Time Frame: 29 month ]
To determine if the combination of BN-Brachyury administered with radiotherapy will result in a clinically meaningful ORR when compared with historical control
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BN Brachyury and Radiation in Chordoma
Official Title  ICMJE A Phase 2 Trial of BN-Brachyury and Radiation Therapy in Patients With Advanced Chordoma
Brief 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 will be needed to proceed to stage 2.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chordoma
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: BN-Brachyury plus radiation
MVA-BN-Brachyury then treatment of the tumor(s) with radiation followed by FPV-Brachyury
Intervention: Biological: BN-Brachyury plus radiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 12, 2018)
29
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03595228
Other Study ID Numbers  ICMJE BRACHY-CHOR-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Bavarian Nordic
Study Sponsor  ICMJE Bavarian Nordic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gregory Cote, MD Massachusetts General Hospital
PRS Account Bavarian Nordic
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP