A Study of Nivolumab Plus Chemotherapy in First Line Treatment of Adult Participants With Advanced or Metastatic Gastric Cancer

Active, not recruiting

• Conditions: Gastric Cancer

• Registration Number: NCT05165264
• Lead Sponsor: Bristol-Myers Squibb

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2021-12-08
• Study First Posted: 2021-12-21
• Study Start: 2022-02-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-03
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months	Defined as time since initial diagnosis and treatment with nivolumab to either the first disease progression date or last known tumour assessment date, or death due to any cause, whichever occurs first.
Overall response rate (ORR)	From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months	Defined as investigator assessed complete response, partial response, stable disease, or progressive disease.
Duration of response	From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months	Defined as time from response to progression
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	Defined as time since initial diagnosis and treatment with nivolumab until date of death due to any cause.
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

Trial Locations

Locations (1)

Local Institution - 0001; 🇩🇪 Hamburg, Germany