Clinical Study of Regorafenib and Nivolumab Plus Chemotherapy

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 6, 2022

Primary Completion Date

April 14, 2024

Study Completion Date

November 30, 2025

Conditions
Gastric AdenocarcinomaGastroesophageal Junction AdenocarcinomaEsophageal Adenocarcinoma
Interventions
DRUG

Regorafenib

"90 mg administered orally, once daily for 21 consecutive days followed by 7 days off~\*Repeat every 4 weeks as Regorafenib therapy"

DRUG

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

DRUG

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"

DRUG

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"

Trial Locations (1)

277-8577

National Cancer Center Hospital East, Kashiwa

All Listed Sponsors
collaborator

Bayer Yakuhin, Ltd.

INDUSTRY

lead

National Cancer Center Hospital East

OTHER