A Study to Evaluate Nivolumab in Patients With Unresectable Advanced/Metastatic Gastric Cancer and Gastroesophageal Junction Cancer

NCT06452329 | Completed FDA Drug

• 1 other identifier: CA209-1429
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to collect and evaluate real-world data to enhance understanding of the effectiveness, and treatment patterns of first-line nivolumab treatment in patients with unresectable advanced or metastatic gastric cancer/gastroesophageal junction cancer (GC/GEJC) in China

Conditions

Gastric Cancer; Gastroesophageal Junction Cancer

Outcome Measures

Primary Outcomes (1)

• Time to progression (TTP)

  Up to 68 months

Secondary Outcomes (5)

• Objective response rate (ORR)

  Up to 68 months

• Duration of response (DOR)

  Up to 68 months

• Participant socio-demographics

  Baseline

• Participant baseline clinical characteristics

  Baseline

• Participant treatment patterns

  Up to 68 months

Study Arms (1)

Participants who received first-line nivolumab therapy for advanced GC/GEJC

Drug: Nivolumab

Interventions

Nivolumab DRUG

As prescribed by treating physician

Participants who received first-line nivolumab therapy for advanced GC/GEJC

Eligibility Criteria

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

Study Population

Adult patients diagnosed with unresectable advanced or metastatic Gastric Cancer (GC) or Gastroesophageal Junction Cancer (GEJC) treated with nivolumab as first-line treatment.

You may qualify if:

• Participants aged ≥ 18 years at date of first administration of nivolumab
• Confirmed diagnosis of unresectable advanced or metastatic Gastric Cancer (GC) or Gastroesophageal Junction Cancer (GEJC) (histologically or cytologically)
• Participants newly received nivolumab as first-line (1L) treatment between 15 June 2018 and 30 June 2023
• Participants with at least one tumor assessment after index date except for death or discontinuation due to Adverse Events

You may not qualify if:

• Participants with primary malignancies other than unresectable advanced or metastatic GC/GEJC
• Participants who participate in an interventional clinical trial in or before 1L nivolumab treatment for advanced/metastatic GC/GEJC
• Participants with known HER2 status positive

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Local Institution - 0001

Wuhan, Hubei, 430030, China

Location

Tianjin Happy Life Technology Co., Ltd

Shanghai, China

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: February 28, 2024
• Primary Completion: July 29, 2025
• Study Completion: July 29, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)