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

Gastric Cancer Clinical Trial

— INGA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05165264
• Other study ID #: CA209-8EC
• Status: Recruiting
• Start date: February 16, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2022
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
Germany	Local Institution	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)		From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
Secondary	Progression-free survival (PFS)	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.	From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
Secondary	Overall response rate (ORR)	Defined as investigator assessed complete response, partial response, stable disease, or progressive disease.	From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
Secondary	Duration of response	Defined as time from response to progression	From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
Secondary	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
Secondary	Overall Survival (OS)	Defined as time since initial diagnosis and treatment with nivolumab until date of death due to any cause.	From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
Secondary	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

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form