Study of Adjuvant ONO-4538 With Resected Gastric Cancer

Ono Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Gastric Cancer

Treatments: Drug: Tegafur-gimeracil-oteracil potassium; Drug: Nivolumab; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03006705

ONO-4538-38

Details and patient eligibility

About

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.

Enrollment: 800 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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800 participants in 2 patient groups, including a placebo group

Nivolumab group

Experimental group

Description:

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.

Treatment:

Drug: Oxaliplatin

Drug: Tegafur-gimeracil-oteracil potassium

Drug: Capecitabine

Drug: Nivolumab

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Oxaliplatin

Drug: Placebo

Drug: Tegafur-gimeracil-oteracil potassium

Drug: Capecitabine