NCT04134312

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Bavarian Nordic · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Solid Metastatic Tumor

Interventions

Type	Name	Description
BIOLOGICAL	MVA-BN-Brachyury	MVA-BN-Brachyury will be administered intravenously every three weeks with three administrations in total at the dose indicated by the enrolled cohort.

Timeline

• Start date: 2020-01-08
• Primary completion: 2021-01-12
• Completion: 2021-04-06
• First posted: 2019-10-22
• Last updated: 2021-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study