A NON-INTERVENTIONAL OBSERVATIONAL STUDY OF EFFECTIVENESS AND SAFETY OF NIVOLUMAB PLUS CHEMOTHERAPY FOR UNTREATED ADVANCED / RECURRENT GASTRIC CANCER

Not Applicable

• Conditions: ADVANCED/GASTRIC CANCER

• Registration Number: JPRN-UMIN000046820
• Lead Sponsor: Bristol-Myers Squibb K.K. Ono Pharmaceutical CO.LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-03
• Last Update Posted: 1 April 2024
• Study Completion: 2026-01-16

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

To participate in this study, the following criteria MUST NOT be met at the time of informed consent: 1.Patients who have been treated with antineoplastic agents as first-line treatment for advanced or recurrent gastric cancer prior to the initiation of nivolumab plus chemotherapy (patients who have received prior perioperative chemotherapy and patients who have received prior bisphosphonates for osseous metastases may be enrolled). 2.Patients who have been confirmed to be positive for HER2. 3.Patients who have been diagnosed with gastric cancer and have previously received investigational drugs with anti-tumor effects for gastric cancer. 4.Patients who were initiated with nivolumab plus chemotherapy as the first-line treatment for advanced or recurrent gastric cancer at a site other than the study site and were later hospitalized at the study site. 5.Other patients judged by the investigators to be inappropriate for enrollment in this study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness -Progression-free survival (PFS) -Objective response rate (ORR) Safety -Incidence of all immune-related adverse events (irAE) according to CTCAE v5.0 -Incidence of treatment-related adverse events (TRAE) that have led to treatment discontinuation

Secondary Outcome Measures

Name	Time	Method
Effectiveness -Overall survival (OS) -Duration of treatment (DOT) -Duration of response (DOR) -DOT of second-line treatment -PFS, ORR, and DOT of nivolumab treatment in third or later line treatment -OS, PFS, ORR, and DOT by patient characteristics Actual treatment status -Time to next treatment (TNT) -Rate of patients who have received subsequent therapy -Treatment status Safety -Safety by patient characteristics