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

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Contents

clinicaltrials.gov/study/NCT03349983
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT033499830
Trial Recruitment Size
110
Trial Sponsor
Bavarian Nordic
Bavarian Nordic
0
Clinical Trial Start Date
January 8, 2018
0
Primary Completion Date
June 13, 2020
0
Study Completion Date
June 13, 2020
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Biological0
Intervention Name
MVA-BN-Brachyury/ FPV-Brachyury0
Interventional Trial Phase
Phase 10
Official Name
An Open-label Phase 1 Trial to Evaluate the Safety and Tolerability of a Modified Vaccinia Ankara (MVA) Priming Followed by Fowlpox Booster Vaccines Modified to Express Brachyury and T-cell Costimulatory Molecules (MVA-BN-Brachyury/FPV-Brachyury)0
Last Updated
August 26, 2020
0
Allocation Type
NA0
Intervention Model
Sequential Assignment0
Masking Type
None (Open Label)0
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).

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