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BN Brachyury and Radiation in Chordoma

Sponsor
Bavarian Nordic (Industry)
Overall Status
Completed
CT.gov ID
NCT03595228
Collaborator
(none)
29
Enrollment
5
Locations
1
Arm
38.8
Actual Duration (Months)
5.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: BN-Brachyury plus radiation
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
N/A
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 :
Oct 31, 2018
Actual Primary Completion Date :
Dec 10, 2021
Actual Study Completion Date :
Jan 25, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Clinically Meaningful Objective Response Rate [27 months]

    Objective response rate anytime within 12 months post completion of radiation on target lesion(s) based on RECIST 1.1

Secondary Outcome Measures

  1. Safety of BN-Brachyury: adverse events [42 months]

    Incidence of treatment-emergent adverse events

  2. Clinical Benefit of BN-Brachyury plus radiation therapy [42 months]

    Evaluate other clinical endpoints that might be indicative of clinical benefits (PFS, improvement of other clinical symptoms)

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy 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

Locations

Site City State Country Postal Code
1 Mayo Clinic, Arizona Phoenix Arizona United States 85054
2 Mayo Clinic, Florida Jacksonville Florida United States 32224
3 Massachusetts General Hospital, Cancer Center Boston Massachusetts United States 02114
4 Washington University School of Medicine Saint Louis Missouri United States 63110
5 MD Anderson Cancer Center Houston Texas United States 77030

Sponsors and Collaborators

  • Bavarian Nordic

Investigators

  • Principal Investigator: Gregory Cote, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bavarian Nordic
ClinicalTrials.gov Identifier:
NCT03595228
Other Study ID Numbers:
  • BRACHY-CHOR-001
First Posted:
Jul 23, 2018
Last Update Posted:
Feb 28, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Chordoma

Study Results

No Results Posted as of Feb 28, 2022