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NCT04134312

A Phase 1 Open Label Trial of Intravenous Administration of MVA-BN-Brachyury Vaccine in Patients With Advanced Cancer

Completed Phase 1 Last updated 14 July 2021
What this trial tests

Phase 1 trial testing MVA-BN-Brachyury in Solid Metastatic Tumor in 13 participants. Completed in 6 April 2021.

Timeline
8 January 2020
Primary endpoint
12 January 2021
6 April 2021

Quick facts

Lead sponsorBavarian Nordic
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment13
Start date8 January 2020
Primary completion12 January 2021
Estimated completion6 April 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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

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Other trials of MVA-BN-Brachyury

Trials testing the same drug.

Other Bavarian Nordic trials

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Data sources for this page

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.

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