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

NCT05334719 | Completed

• 1 other identifier: CA209-6HP
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Stomach Neoplasms

Keywords

Nivolumab; Advanced or Recurrent; Gastric Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Overall survival (OS)

  Up to approximately 4 years

• Duration of response (DOR)

  Up to approximately 4 years

• Duration of treatment (DOT)

  Up to approximately 4 years

• Time to next treatment (TNT)

  Up to approximately 4 years

• Number of participants who have received subsequent therapy

  Up to approximately 4 years

Study Arms (1)

Cohort 1

Participants with previously untreated advanced/recurrent gastric cancer (GC)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include participants who received nivolumab plus chemotherapy as first-line treatment for unresectable advanced or recurrent gastric cancer at least once between nivolumab plus chemotherapy approval and December 31, 2022.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Ono Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Local Institution - 0001

Minato-ku, Tokyo, 1050001, Japan

Location

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Stomach Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 19, 2022
• Study Start: June 29, 2022
• Primary Completion: January 16, 2026
• Study Completion: January 16, 2026
• Last Updated: June 18, 2026

Record last verified: 2026-06

Locations

JP (1)