59
Participants
Start Date
May 1, 2018
Primary Completion Date
October 8, 2024
Study Completion Date
October 8, 2024
M7824
1,200 mg intravenous (IV) once every 2 weeks.
N-803
8-15 mcg/kg subcutaneous every 2 weeks.
MVA-BN-Brachyury
MVA-BN-Brachyury will be administered subcutaneously (2 doses 2 weeks apart).
FPV-Brachyury
FPV-Brachyury will be given 2 weeks after second dose of modified vaccinia Ankara (MVA)-Bavarian Nordic (BN)-Brachyury, then every 4 weeks until 6 months, then every 3 months for 2 years, then every 6 months.
Epacadostat
600 mg orally twice daily (1200 MG total).
Acetaminophen
Antipyretic medication, orally, prior to infusion, up to 650mg.
Ibuprofen
Antipyretic medication, orally, prior to infusion, up to 600mg.
Naproxen
Antipyretic medication, orally, prior to infusion, up to 500mg.
Benadryl
50mg orally prior to infusion.
EKG
Baseline and principal investigator discretion.
Bone scan
Restaging every 12 weeks.
CT chest, abdomen and pelvis
Every 12 weeks after start of therapy.
MRI
If clinically indicated.
National Institutes of Health Clinical Center, Bethesda
National Cancer Institute (NCI)
NIH