Description:
The purpose of study is to evaluate the efficacy and safety of postoperative adjuvant
chemotherapy with Nivolumab in combination with tegafur-gimeracil-oteracil potassium (S-1
therapy) or capecitabine + oxaliplatin (CapeOX therapy), in comparison with placebo in
combination with S-1 therapy or CapeOX therapy, in pStage III gastric cancer (including
esophagogastric junction cancer) after D2 or more extensive lymph node dissection.
Title
- Brief Title: Study of Adjuvant ONO-4538 With Resected Gastric Cancer
- Official Title: A Multicenter, Double-blind, Randomized Study in Patients With Gastric Cancer Undergoing Postoperative Adjuvant Chemotherapy
Clinical Trial IDs
- ORG STUDY ID:
ONO-4538-38
- NCT ID:
NCT03006705
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Nivolumab | BMS-936558, ONO-4538, MDX-1106 | Nivolumab group |
| Tegafur-gimeracil-oteracil potassium | | Nivolumab group |
| Oxaliplatin | | Nivolumab group |
| Capecitabine | | Nivolumab group |
| Placebo | | Placebo group |
Purpose
The purpose of study is to evaluate the efficacy and safety of postoperative adjuvant
chemotherapy with Nivolumab in combination with tegafur-gimeracil-oteracil potassium (S-1
therapy) or capecitabine + oxaliplatin (CapeOX therapy), in comparison with placebo in
combination with S-1 therapy or CapeOX therapy, in pStage III gastric cancer (including
esophagogastric junction cancer) after D2 or more extensive lymph node dissection.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Nivolumab group | Experimental | Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).
Chemotherapy: S-1 Therapy or CapeOX Therapy is determined by the investigator.
S-1 therapy(maximum 1 year):
Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off
CapeOX Therapy(maximum 6 months):
Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.
Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off. | - Nivolumab
- Tegafur-gimeracil-oteracil potassium
- Oxaliplatin
- Capecitabine
|
| Placebo group | Placebo Comparator | Placebo: Placebo solution intravenously for 30 min in every 3 weeks (maximum 1 year).
Chemotherapy: S-1 Therapy or CapeOX Therapy is determined by the investigator.
S-1 therapy(maximum 1 year):
Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off
CapeOX Therapy(maximum 6 months):
Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.
Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off. | - Tegafur-gimeracil-oteracil potassium
- Oxaliplatin
- Capecitabine
- Placebo
|
Eligibility Criteria
Inclusion Criteria:
- Patients with histologically confirmed adenocarcinoma of the stomach
- Patients without a remnant cancer (R0) who have undergone gastrectomy
- Gastric carcinoma according to the stage classification of AJCC/UICC TNM
Classification, 7th Edition on the basis of overall postoperative findings
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1
Exclusion Criteria:
- Patients who have received non-surgical treatment (e.g., radiotherapy, chemotherapy,
hormone therapy) for gastric cancer
- Multiple primary cancers
- A current or past history of severe hypersensitivity to any other antibody products
- Any concurrent autoimmune disease or past history of chronic or recurrent autoimmune
disease
| Maximum Eligible Age: | 80 Years |
| Minimum Eligible Age: | 20 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Relapse-free survival (RFS) |
| Time Frame: | 5 years |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Overall survival (OS) |
| Time Frame: | 5 years |
| Safety Issue: | |
| Description: | |
| Measure: | 3-year OS rate |
| Time Frame: | 3 years |
| Safety Issue: | |
| Description: | |
| Measure: | 5-year OS rate |
| Time Frame: | 5 years |
| Safety Issue: | |
| Description: | |
| Measure: | 3-year RFS rate |
| Time Frame: | 3 years |
| Safety Issue: | |
| Description: | |
| Measure: | 5-year RFS rate |
| Time Frame: | 5 years |
| Safety Issue: | |
| Description: | |
| Measure: | Safety will be analyzed through the incidence of adverse events, serious adverse events |
| Time Frame: | Up to 28 days from last dose |
| Safety Issue: | |
| Description: | |
| Measure: | Safety will be analyzed through the incidence of laboratory abnormalities |
| Time Frame: | Up to 28 days from last dose |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Ono Pharmaceutical Co. Ltd |
Trial Keywords
- ONO-4538,BMS-936558,Nivolumab,gastric,adjuvant,S-1,CapeOX
Last Updated
October 14, 2020
