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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05165264

Collaborator

(none)

600

Enrollment

Location

58.4

Anticipated Duration (Months)

10.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 16, 2022

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1 Participants with previously untreated advanced or metastatic gastric cancer (GC), gastro-oesophageal junction (GEJ) or oesophageal adenocarcinoma (EAC)

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.