A Study of the Effectiveness and Safety of Nivolumab Plus Chemotherapy in Participants With Untreated Advanced/Recurrent Gastric Cancer

Active, not recruiting

• Conditions: Stomach Neoplasms

• Registration Number: NCT05334719
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to assess the effectiveness, safety, and actual treatment status of first-line nivolumab plus chemotherapy in participants with untreated advanced / recurrent gastric cancer in a Japanese real-world setting.

Detailed Description

The Time Perspective for this observational study is defined as 'Retrospective and Prospective'.

Study Timeline

• Study Start: 2022-02-03
• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-04-12
• Study First Posted: 2022-04-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08
• Primary Completion: 2026-01-16
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Histologically confirmed advanced or recurrent gastric cancer
• Have initiated or are confirmed to receive nivolumab plus chemotherapy as the first-line therapy between the date of approval of nivolumab plus chemotherapy and December 31, 2022. For combination chemotherapy, SOX, CapeOX, or FOLFOX is acceptable
• Have signed a written informed consent form of their own free will after they have been given an adequate explanation and a full understanding of this study before enrolling in this study.

Exclusion Criteria

• Treated with antineoplastic agents as first-line treatment for advanced or recurrent gastric cancer prior to the initiation of nivolumab plus chemotherapy (participants who have received prior perioperative chemotherapy and participants who have received prior bisphosphonates for osseous metastases may be enrolled)
• Confirmed to be positive for HER2
• Diagnosed with gastric cancer and have previously received investigational drugs with anti-tumor effects
• 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.
• 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
Progression-free survival (PFS)	Up to approximately 4 years
Objective response rate (ORR)	Up to approximately 4 years
Incidence of all immune-related adverse events (irAE) according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0	Up to approximately 4 years
Incidence of treatment-related adverse events (TRAE) that have led to treatment discontinuation	Up to approximately 4 years

Secondary Outcome Measures

Name	Time	Method
Duration of treatment (DOT)	Up to approximately 4 years
Time to next treatment (TNT)	Up to approximately 4 years
Overall survival (OS)	Up to approximately 4 years
Duration of response (DOR)	Up to approximately 4 years
Number of participants who have received subsequent therapy	Up to approximately 4 years
Incidence of Adverse Events (AEs)	Up to approximately 4 years

Trial Locations

Locations (1)

Local Institution - 0001; 🇯🇵 Minato-ku, Tokyo, Japan