A Study of the Effectiveness and Safety of Nivolumab Plus Chemotherapy in Participants With Untreated Advanced/Recurrent Gastric Cancer

Stomach Neoplasms Clinical Trial

— G-KNIGHT  

Official title:

A Non-interventional Observational Study of Effectiveness and Safety of Nivolumab Plus Chemotherapy for Untreated Advanced / Recurrent Gastric Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05334719
• Other study ID #: CA209-6HP
• Status: Active, not recruiting
• Start date: February 3, 2022
• Est. completion date: September 30, 2026

Study information

• Verified date: April 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess the effectiveness, safety, and actual treatment status of first-line nivolumab plus chemotherapy in participants with untreated advanced / recurrent gastric cancer in a Japanese real-world setting.

Description:

The Time Perspective for this observational study is defined as 'Retrospective and Prospective'.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: September 30, 2026
• Est. primary completion date: January 16, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed advanced or recurrent gastric cancer

• Have initiated or are confirmed to receive nivolumab plus chemotherapy as the first-line therapy between the date of approval of nivolumab plus chemotherapy and December 31, 2022. For combination chemotherapy, SOX, CapeOX, or FOLFOX is acceptable

• Have signed a written informed consent form of their own free will after they have been given an adequate explanation and a full understanding of this study before enrolling in this study.

Exclusion Criteria:

• Treated with antineoplastic agents as first-line treatment for advanced or recurrent gastric cancer prior to the initiation of nivolumab plus chemotherapy (participants who have received prior perioperative chemotherapy and participants who have received prior bisphosphonates for osseous metastases may be enrolled)

• Confirmed to be positive for HER2

• Diagnosed with gastric cancer and have previously received investigational drugs with anti-tumor effects

• Initiated with nivolumab plus chemotherapy as the first-line treatment for advanced or recurrent gastric cancer at a site other than the study site and were later hospitalized at the study site.

• Judged by the investigators to be inappropriate for enrollment in this study

Related Conditions & MeSH terms

• Stomach Neoplasms

Locations

Country	Name	City	State
Japan	Local Institution	Minato-ku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)		Up to approximately 4 years
Primary	Objective response rate (ORR)		Up to approximately 4 years
Primary	Incidence of all immune-related adverse events (irAE) according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0		Up to approximately 4 years
Primary	Incidence of treatment-related adverse events (TRAE) that have led to treatment discontinuation		Up to approximately 4 years
Secondary	Overall survival (OS)		Up to approximately 4 years
Secondary	Duration of response (DOR)		Up to approximately 4 years
Secondary	Duration of treatment (DOT)		Up to approximately 4 years
Secondary	Time to next treatment (TNT)		Up to approximately 4 years
Secondary	Number of participants who have received subsequent therapy		Up to approximately 4 years
Secondary	Incidence of Adverse Events (AEs)		Up to approximately 4 years

External Links

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