30
Participants
Start Date
June 6, 2022
Primary Completion Date
April 14, 2024
Study Completion Date
November 30, 2025
Regorafenib
"90 mg administered orally, once daily for 21 consecutive days followed by 7 days off~\*Repeat every 4 weeks as Regorafenib therapy"
Nivolumab
CohotA:360 mg administered intravenously, every 3 weeks \*Administered on the same day as CapeOX therapy Cohort B: 240 mg administered intravenously, every 2 weeks \*Administered on the same day as FOLFOX therapy
CapeOX
"For Cohort A only~* Capecitabine 1,000 mg/m\^2 administered orally, twice daily (Days 1 to 14 continuous dosing of CapeOX therapy)~* Oxaliplatin 130 mg/m\^2 administered intravenously (Day 1 of CapeOX therapy) \*Repeat every 3 weeks as CapeOX therapy"
FOLFOX regimen
"For Cohort B only~* Leucovorin 400 mg/m\^2 administered intravenously (Day 1 of FOLFOX therapy)~* Fluorouracil 400 mg/m\^2 administered intravenously (Day 1 of FOLFOX therapy) and 1,200 mg/m2 administered intravenously (Days 1 to 2 of FOLFOX therapy)~* Oxaliplatin 85 mg/m\^2 administered intravenously (Day 1 of FOLFOX therapy) \*Repeat every 2 weeks as FOLFOX therapy"
National Cancer Center Hospital East, Kashiwa
Bayer Yakuhin, Ltd.
INDUSTRY
National Cancer Center Hospital East
OTHER