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Safety and Tolerability Trial (MVA-BN-Brachyury/FPV-Brachyury)

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ClinicalTrials.gov Identifier: NCT03349983
Recruitment Status : Recruiting
First Posted : November 22, 2017
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Bavarian Nordic

Brief Summary:
An open-label Phase 1 trial to evaluate the safety and tolerability of MVA-BN-Brachyury priming and FPV-Brachyury boost vaccines modified to express brachyury and T-cell costimulatory molecules in patients with a metastatic or unresectable locally advanced malignant solid tumor. Subjects will be given the following subcutaneous doses: two prime doses with MVA-BN-Brachyury and monthly boost doses with FPV-Brachyury for 6 months. The study will last approximately 104 weeks before starting long term follow up (FU).

Condition or disease Intervention/treatment Phase
Safety Issues Biological: MVA-BN-Brachyury/ FPV-Brachyury Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Phase 1 Trial to Evaluate the Safety and Tolerability of a Modified Vaccinia Ankara (MVA) Priming Followed by Fowlpox Booster Vaccines Modified to Express Brachyury and T-cell Costimulatory Molecules (MVA-BN-Brachyury/FPV-Brachyury)
Actual Study Start Date : January 8, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : November 2024

Arm Intervention/treatment
Experimental: MVA-BN-Brachyury/ FPV-Brachyury Biological: MVA-BN-Brachyury/ FPV-Brachyury
Two priming doses of MVA-BN-Brachyury followed by boost doses of FPV-Brachyury monthly for 6 months




Primary Outcome Measures :
  1. Patients with Dose Limiting Toxicity [ Time Frame: up to 8 weeks ]
    Fraction of patients who experience a (Dose Limiting Toxicity) DLT.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have a metastatic or unresectable locally advanced malignant solid tumor, histologically confirmed by the Laboratory of Pathology, NCI. In the case of chordoma, unresectable, locally recurrent, or metastatic tumors are acceptable for enrollment, given that this represents incurable disease. Efforts will be made, as much as possible, to enroll patients with tumor types with known increased expression of brachyury (such as lung, breast, ovarian, prostate, colorectal, pancreatic, hepatocellular, Merkel cell, small cell lung cancer or chordoma; other tumors may be included as data on the level of brachyury in those tumors becomes available). Every attempt will be made to collect archival tissue, preferably metastatic disease.
  • Patients may have measurable or nonmeasurable but evaluable disease. Patients with surgically resected metastatic disease at high risk of relapse or patients with metastatic disease with a complete response after palliative chemotherapy with at high risk of relapse (such as small cell lung cancer, etc) are also eligible.
  • Prior therapy: Patients must have completed or had disease progression on at least one prior line of disease-appropriate therapy for metastatic disease, or not be candidates for therapy of proven efficacy for their disease.
  • There should be a minimum of 4 weeks from any prior chemotherapy, immunotherapy and/or radiation, with the following exceptions:

    1. Prostate cancer - patients must continue to receive GnRH agonist therapy (unless orchiectomy has been done). Patients on combined androgen blockade therapy may continue those therapies as well (bicalutamide, nilutamide, flutamide, enzalutamide and abiraterone).
    2. Breast cancer - patients may remain on hormonal therapy if indicated (ER/PR+), HER2-directed therapy for HER2+ breast cancer (3+ IHC or FISH+).
    3. EGFR-mutated lung cancer - patient may remain on first line EGFR inhibiting therapy (tyrosine kinase inhibitors) if they have had stable disease or ongoing response to therapy. Patients with T790M mutations may continue receiving osimertinib while receiving vaccine.
    4. Mestastatic colorectal cancer may continue "maintenance" therapy with capecitabine and/or bevacizumab.
  • There should be a minimum of 6 weeks from any prior antibody therapies, (such as ipilimumab or anti-PD1/PDL1) due to prolonged half-life.
  • Patients must have recovered (grade 1 or baseline) from any clinically significant toxicity associated with prior therapy.
  • Age ≥ 18 years.
  • ECOG performance status ≤ 1 (Karnofsky ≥ 70%)
  • Patients must have normal organ and marrow function as defined in protocol
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to trial entry and for the duration of trial participation and for a period of 4 months after the last vaccination therapy.)
  • Patients must be able to understand and be willing to sign a written informed consent document.

Exclusion Criteria:

  • Concurrent treatment for cancer, with specific exceptions noted in 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.
  • Concurrent use of systemic steroids, except for physiologic doses of systemic steroid replacement or local (topical, nasal, or inhaled) steroid use. Limited pharmacologic doses of systemic steroids (e.g., in patients with exacerbations of reactive airway disease or to prevent I.V. contrast allergic reaction or anaphylaxis in patients who have known contrast allergies) are allowed.
  • Patients who are receiving any other investigational agents within 28 days before start of trial treatment.
  • Patients with untreated central nervous system metastases or local treatment of brain metastases within the last 6 months. Patients with stable brain metastasis for 6 months post-intervention are eligible. Subjects with chordoma will be eligible regardless of site of disease if other eligibility criteria are met.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to BN-Brachyury or other agents used in trial. History of allergic reaction to aminoglycoside antibiotics or egg products.
  • Serious or uncontrolled intercurrent illness including, 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.
  • HIV-positive patients.

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): NCT03349983


Contacts
Contact: Christopher Heery, MD 866-378-5237 Christopher.Heery@bavarian-nordic.com

Locations
United States, Maryland
Genitourinary Malignancies Branch National Cancer Institute Recruiting
Bethesda, Maryland, United States, 20892
Contact    240-760-6050    Marijo.bilusic@nih.gov   
Principal Investigator: Marijo Bilusic, MD         
Sponsors and Collaborators
Bavarian Nordic
Investigators
Principal Investigator: Marijo Bilusic, MD National Cancer Institute (NCI)

Responsible Party: Bavarian Nordic
ClinicalTrials.gov Identifier: NCT03349983     History of Changes
Obsolete Identifiers: NCT03411486
Other Study ID Numbers: BRACHY-MVA-FPV-001
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

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