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

NCT03349983 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2020-08-26

No results posted yet for this study

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).

Conditions

  • Safety Issues

Interventions

BIOLOGICAL

MVA-BN-Brachyury/ FPV-Brachyury

Two priming doses of MVA-BN-Brachyury followed by boost doses of FPV-Brachyury monthly for 6 months

Sponsors & Collaborators

  • Bavarian Nordic

    lead INDUSTRY

Principal Investigators

  • Marijo Bilusic, MD · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-08
Primary Completion
2020-06-13
Completion
2020-06-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03349983 on ClinicalTrials.gov