NCT03349983 is a Phase 1 clinical trial of MVA-BN-Brachyury/ FPV-Brachyury in Safety Issues, sponsored by Bavarian Nordic.

Who is sponsoring NCT03349983?

NCT03349983 is sponsored by Bavarian Nordic.

What drugs are being tested in NCT03349983?

Interventions in NCT03349983: MVA-BN-Brachyury/ FPV-Brachyury.

What condition does NCT03349983 study?

NCT03349983 studies Safety Issues.

Is NCT03349983 still recruiting?

NCT03349983 is currently completed. Last updated 26 August 2020.

Last reviewed 2020-08-26 · How we verify

NCT03349983

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 26 August 2020

What this trial tests

Phase 1 trial testing MVA-BN-Brachyury/ FPV-Brachyury in Safety Issues in 11 participants. Completed in 13 June 2020.

Timeline

8 January 2018

Primary endpoint
13 June 2020

13 June 2020

Quick facts

Lead sponsor	Bavarian Nordic
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	8 January 2018
Primary completion	13 June 2020
Estimated completion	13 June 2020
Sites	1 location across United States

Drugs / interventions tested

MVA-BN-Brachyury/ FPV-Brachyury — full drug profile →

Conditions studied

Safety Issues — all drugs for Safety Issues →

Sponsor

Bavarian Nordic — full company profile →

Who can join

Adults 18 to 85, any sex, with Safety Issues. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Molecular Targeted Therapy in the Treatment of Chordoma: A Systematic Review.
Meng T, Jin J, Jiang C, Huang R, et al · · 2019 · cited 70× · PMID 30775316 · DOI 10.3389/fonc.2019.00030
Phase 1 open-label trial of intravenous administration of MVA-BN-brachyury-TRICOM vaccine in patients with advanced cancer.
DeMaria PJ, Lee-Wisdom K, Donahue RN, Madan RA, et al · · 2021 · cited 26× · PMID 34479925 · DOI 10.1136/jitc-2021-003238
Phase I Trial of a Modified Vaccinia Ankara Priming Vaccine Followed by a Fowlpox Virus Boosting Vaccine Modified to Express Brachyury and Costimulatory Molecules in Advanced Solid Tumors.
Collins JM, Donahue RN, Tsai YT, Manu M, et al · · 2020 · cited 21× · PMID 31876334 · DOI 10.1634/theoncologist.2019-0932
The role of tumor immune microenvironment in chordoma: promising immunotherapy strategies.
Xu J, Shi Q, Wang B, Ji T, et al · · 2023 · cited 14× · PMID 37720221 · DOI 10.3389/fimmu.2023.1257254
Combinatorial Natural Killer Cell-based Immunotherapy Approaches Selectively Target Chordoma Cancer Stem Cells.
Hoke ATK, Padget MR, Fabian KP, Nandal A, et al · · 2021 · cited 14× · PMID 35765577 · DOI 10.1158/2767-9764.crc-21-0020
Cancer vaccines.
Rousseau RF, Hirschmann-Jax C, Takahashi S, Brenner MK. · · 2001 · cited 13× · PMID 11676282 · DOI 10.1016/s0889-8588(05)70245-8
New Prospects for Molecular Targets for Chordomas.
Ozair MZ, Shah PP, Mathios D, Lim M, et al · · 2020 · cited 7× · PMID 32147018 · DOI 10.1016/j.nec.2019.11.004

Verify or expand the search:

Other recruiting trials for Safety Issues

Currently open trials in the same condition.

NCT06485141 — BeSMART Secure Storage Counseling in the Inpatient Setting · NA · recruiting
NCT06494527 — A Phase 1 Study to Evaluate the Safety/Tolerability, PK/PD of RG002C0106 Injection in Healthy Adults · Phase 1 · active not recruiting
NCT06189170 — Phase I Study to Evaluate KP405 in Healthy and Parkinson's Disease Patients · EARLY_PHASE1 · recruiting
NCT06509490 — NKG2D CAR-T(KD-025) in the Treatment of Advanced NKG2DL+ Solid Tumors · NA · recruiting
NCT06498167 — Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib) · recruiting

Other Bavarian Nordic trials

Trials by the same sponsor.

NCT07199569 — Comparability Trial of the MVA-BN Vaccine Manufactured in Different Production Cells · Phase 2 · active not recruiting
NCT06549530 — Open-label, Multicenter Immunogenicity and Safety Study of MVA-BN Vaccine in Children From 2 Years to Less Than 12 Years · Phase 2 · active not recruiting
NCT05329220 — ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2 · Phase 3 · completed
NCT05349617 — Safety and Immunogenicity of CHIKV VLP Vaccine PXVX0317 in Adults ≥65 Years · Phase 3 · completed
NCT05238025 — MVA-BN-RSV Vaccine Trial · Phase 3 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03349983 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bavarian Nordic
Last refreshed: 26 August 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03349983.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing