Skip to main content
OpenTrials
Completed

NCT Number: NCT05334719

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stomach Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Attributes Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Stomach Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001

Minato-ku, Tokyo, 1050001, Japan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: Up to approximately 4 years

  2. Objective response rate (ORR)

    Time frame: Up to approximately 4 years

  3. Incidence of all immune-related adverse events (irAE) according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0

    Time frame: Up to approximately 4 years

  4. Incidence of treatment-related adverse events (TRAE) that have led to treatment discontinuation

    Time frame: Up to approximately 4 years

Secondary outcomes

  1. Overall survival (OS)

    Time frame: Up to approximately 4 years

  2. Duration of response (DOR)

    Time frame: Up to approximately 4 years

  3. Duration of treatment (DOT)

    Time frame: Up to approximately 4 years

  4. Time to next treatment (TNT)

    Time frame: Up to approximately 4 years

  5. Number of participants who have received subsequent therapy

    Time frame: Up to approximately 4 years

  6. Incidence of Adverse Events (AEs)

    Time frame: Up to approximately 4 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Ono Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Acronym: G-KNIGHT

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 19, 2022
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.