NCT05394740

Clinical Study of Regorafenib and Nivolumab Plus Chemotherapy

A Phase Ib/II Study of Regorafenib and Nivolumab Plus Chemotherapy in Patients With Unresectable Advanced/Recurrent Gastric/Gastroesophageal Junction/Esophageal Adenocarcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: National Cancer Center Hospital East · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm, single-center Phase Ib/II study to exploratorily evaluate the tolerability, safety, and efficacy of regorafenib and nivolumab plus chemotherapy in patients with unresectable advanced/recurrent gastric/ gastroesophageal junction/esophageal adenocarcinoma.

Detailed description

Phase Ib part: To evaluate safety and tolerability in combination of Regorafenib, Nivolumab and chemotherapy in patient with unresectable advanced/recurrent gastric/ gastroesophageal junction/esophageal adenocarcinoma and to determine recommended dose in phase II part. Phase II part: To evaluate safety and potential efficacy in combination of Regorafenib, Nivolumab and chemotherapy in patients in expanded arm. The protocol treatment in this study is regorafenib and nivolumab plus CapeOX (Cohort A) / FOLFOX (Cohort B). Regorafenib (the initial dose is 90 mg/dose) is orally administered daily for 21 days, followed by a 7-day washout period. Nivolumab is administered intravenously at a dose of 360 mg every 3 weeks (Cohort A) or 240 mg every 2 weeks (Cohort B). Cohort A:CapeOX * 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 Cohort B:FOLFOX * 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

Conditions

• Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma
• Esophageal Adenocarcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-06-06
• Primary completion: 2024-04-14
• Completion: 2025-08-25
• First posted: 2022-05-27
• Last updated: 2026-04-09

Locations

1 site across 1 country: Japan