A National, Prospective, Non-interventional Study (NIS) of Nivolumab Plus Chemotherapy in First Line Treatment of Adult Patients With HER2 Negative Advanced or Metastatic Gastric, Gastro-oesophageal Junction or Oesophageal Adenocarcinoma Whose Tumours Express PD-L1 With a CPS ≥5

Bristol-Myers Squibb1 site in 1 country600 target enrollmentFebruary 16, 2022

ConditionsGastric Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gastric Cancer
Sponsor: Bristol-Myers Squibb
Enrollment: 600
Locations: 1
Primary Endpoint: Overall Survival (OS)
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this observational study is to assess the effectiveness and safety of nivolumab in participants with previously untreated advanced or metastatic Gastric Cancer (GC), Gastro-oesophageal Junction (GEJ) Adenocarcinoma, or Oesophageal Adenocarcinoma (EAC).

Registry

clinicaltrials.gov

Start Date

February 16, 2022

End Date

December 31, 2026

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of HER2 negative advanced or metastatic HER2-negative GC, GEJ adenocarcinoma or EAC whose tumours express PD-L1 with a CPS ≥ 5
•Whose physician has decided to start a treatment with nivolumab (according to the German marketing authorization) for the treatment of GC, GEJ adenocarcinoma or EAC and prior to study participation

Exclusion Criteria

•Previous malignancy within 3 years or concomitant malignancy, except: those with a 5-year overall survival rate of more than 90%, e.g. non-melanomatous skin cancer or adequately treated in situ cervical cancer.
•Participants currently included in an interventional clinical trial for their advanced or metastatic GC, GEJ adenocarcinoma or EAC. Participants who have completed their participation in an interventional trial or who are not receiving any study drug anymore and who are only in the follow-up Phase for OS can be enrolled. For blinded studies, the study drug administered needs to be known at the time of enrolment.

Outcomes

Primary Outcomes

Overall Survival (OS)

Time Frame: From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months

Secondary Outcomes

Progression-free survival (PFS)(From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months)
Overall response rate (ORR)(From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months)
Duration of response(From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months)
Incidence of Adverse Events (AEs)(From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months)
Overall Survival (OS)(From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months)
OS measured by Programmed Death-Ligand 1 (PD-L1) combined positive score (CPS)(From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months)