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NCT04134312
A Phase 1 Open Label Trial of Intravenous Administration of MVA-BN-Brachyury Vaccine in Patients With Advanced Cancer
Phase 1 trial testing MVA-BN-Brachyury in Solid Metastatic Tumor in 13 participants. Completed in 6 April 2021.
12 January 2021
Quick facts
| Lead sponsor | Bavarian Nordic |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 8 January 2020 |
| Primary completion | 12 January 2021 |
| Estimated completion | 6 April 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- MVA-BN-Brachyury — full drug profile →
Conditions studied
- Solid Metastatic Tumor — all drugs for Solid Metastatic Tumor →
Sponsor
Bavarian Nordic — full company profile →
Who can join
18 and older, any sex, with Solid Metastatic Tumor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Phase 1 open label trial of intravenous administration of MVA-BN-Brachyury vaccine in patients with advanced cancer. Patients with metastatic or unresectable locally advanced malignant solid tumors will be enrolled and treated according to a 3+3 dose escalation scheme. Up to 3 dose levels will be explored. Patients will receive MVA-BN-Brachyury every three weeks, three administrations in total. Patients will be hospitalized after each vaccination, over 48 hours. Trial duration will be approximately 24 weeks per patient including 3 months after the last vaccination follow up (FU) period.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Breast Cancer Stem Cells: Signaling Pathways, Cellular Interactions, and Therapeutic Implications.
Wang L, Jin Z, Master RP, Maharjan CK, et al · · 2022 · cited 29× · PMID 35805056 · DOI 10.3390/cancers14133287 -
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 -
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 -
Personalized nanovaccines for treating solid cancer metastases.
Feng T, Hu J, Wen J, Qian Z, et al · · 2024 · cited 7× · PMID 39609851 · DOI 10.1186/s13045-024-01628-4 -
Synergistic Integration of HDAC Inhibitors and Individualized Neoantigen Therapy (INT): A Next-Generation Combinatorial Approach for Cancer Immunotherapy.
Han R, Zhou H, Peng B, Yu S, et al · · 2025 · cited 3× · PMID 40573881 · DOI 10.3390/vaccines13060550 -
Fast Clearance of the SARS-CoV-2 Virus in a Patient Undergoing Vaccine Immunotherapy for Metastatic Chordoma: A Case Report.
Pastor DM, Lee-Wisdom K, Arai AE, Sirajuddin A, et al · · 2020 · cited 2× · PMID 33330104 · DOI 10.3389/fonc.2020.603248
Verify or expand the search:
- PubMed search for NCT04134312
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of MVA-BN-Brachyury
Trials testing the same drug.
- NCT04020094 — Perioperative Atezolizumab With MVA-BN-Brachyury and PROSTVAC For Intermediate-Risk And High-Risk Localized Prostate Can · Phase 2 · withdrawn
- NCT03493945 — Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1) · Phase 1, PHASE2 · completed
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)
- Trial protocol + status: ClinicalTrials.gov NCT04134312 (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: 14 July 2021
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/NCT04134312.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing