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

June 5, 2024 updated by: Bristol-Myers Squibb

Retrospective Evaluation of Nivolumab in First-Line Unresectable Advanced or Metastatic Gastric Cancer (GC) and Gastroesophageal Junction Cancer (GEJC): A Non-interventional Observational Study in China

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Tianjin Happy Life Technology Co., Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Participants who investigator deems inappropriate for inclusion, for example clinical data was incomplete

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants who received first-line nivolumab therapy for advanced GC/GEJC
Drug: Nivolumab
As prescribed by treating physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to progression (TTP)
Time Frame: Up to 68 months
Up to 68 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Participant baseline clinical characteristics
Time Frame: Baseline
Baseline
Objective response rate (ORR)
Time Frame: Up to 68 months
Up to 68 months
Duration of response (DOR)
Time Frame: Up to 68 months
Up to 68 months
Participant socio-demographics
Time Frame: Baseline
Baseline
Participant treatment patterns
Time Frame: Up to 68 months
Up to 68 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2024

Primary Completion (Estimated)

April 28, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 5, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 5, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-1429

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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