Stomach NeoplasmsG-KNIGHTNCT05334719
A Study of the Effectiveness and Safety of Nivolumab Plus Chemotherapy in Participants With Untreated Advanced/Recurrent Gastric Cancer
An observational study of Stomach Neoplasms, run by Bristol-Myers Squibb at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stomach Neoplasms
- How many people
- 500 participants
- Where
- 1 siteJapan
- Study dates
- 29 Jun 2022to 16 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include participants who received nivolumab plus chemotherapy as first-line treatment for unresectable advanced or recurrent gastric cancer at least once between nivolumab plus chemotherapy approval and December 31, 2022.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-interventional Observational Study of Effectiveness and Safety of Nivolumab Plus Chemotherapy for 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.
Read the detailed description
The Time Perspective for this observational study is defined as 'Retrospective and Prospective'.
- Conditions
- Stomach Neoplasms
- Keywords
- Nivolumab, Advanced or Recurrent, Gastric Cancer
- Medical subject headings
- Stomach Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants with previously untreated advanced/recurrent gastric cancer (GC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Measured: Up to approximately 4 years
Objective response rate (ORR)
Measured: Up to approximately 4 years
Incidence of all immune-related adverse events (irAE) according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: Up to approximately 4 years
Incidence of treatment-related adverse events (TRAE) that have led to treatment discontinuation
Measured: Up to approximately 4 years
Secondary outcomes (6)
Overall survival (OS)
Measured: Up to approximately 4 years
Duration of response (DOR)
Measured: Up to approximately 4 years
Duration of treatment (DOT)
Measured: Up to approximately 4 years
Time to next treatment (TNT)
Measured: Up to approximately 4 years
Number of participants who have received subsequent therapy
Measured: Up to approximately 4 years
Incidence of Adverse Events (AEs)
Measured: Up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start29 Jun 2022
- Primary completion16 Jan 2026
- Study completion16 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334719
- Sponsor's protocol ID
- CA209-6HP
- Acronym
- G-KNIGHT
- Status last verified
- Jun 2026
- First submitted
- 12 Apr 2022
- Last updated
- 18 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Observational Study of Effectiveness and Safety of Nivolumab Plus Chemotherapy for Untreated Advanced / Recurrent Gastric Cancer
- ClinicalTrials.gov ID
- NCT05334719
- Acronym / sponsor ID
- G-KNIGHT / CA209-6HP
- Conditions
- Stomach Neoplasms
- Keywords
- Nivolumab, Advanced or Recurrent, Gastric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- 16 Jan 2026 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Time Perspective for this observational study is defined as 'Retrospective and Prospective'.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Participants with previously untreated advanced/recurrent gastric cancer (GC) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include participants who received nivolumab plus chemotherapy as first-line treatment for unresectable advanced or recurrent gastric cancer at least once between nivolumab plus chemotherapy approval and December 31, 2022.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-free survival (PFS)
Time frame: Up to approximately 4 years
Objective response rate (ORR)
Time frame: Up to approximately 4 years
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
Incidence of treatment-related adverse events (TRAE) that have led to treatment discontinuation
Time frame: Up to approximately 4 years
6 secondary outcomes
Overall survival (OS)
Time frame: Up to approximately 4 years
Duration of response (DOR)
Time frame: Up to approximately 4 years
Duration of treatment (DOT)
Time frame: Up to approximately 4 years
Time to next treatment (TNT)
Time frame: Up to approximately 4 years
Number of participants who have received subsequent therapy
Time frame: Up to approximately 4 years
Incidence of Adverse Events (AEs)
Time frame: Up to approximately 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stomach Neoplasms, run by Bristol-Myers Squibb at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Up to approximately 4 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.