NCT05334719Completed
A Study of the Effectiveness and Safety of Nivolumab Plus Chemotherapy in Participants With Untreated Advanced/Recurrent Gastric Cancer
A Non-interventional Observational Study of Effectiveness and Safety of Nivolumab Plus Chemotherapy for Untreated Advanced / Recurrent Gastric Cancer
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 500 (actual)
- First submitted
- 12 Apr 2022
- Start date
- 29 Jun 2022
- Primary completion date
- 16 Jan 2026
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05334719
What you commit to
- Study type: Observational
- Participants enrolled: 500
- From 29 Jun 2022 to the primary completion date, 16 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Diagnosed with gastric cancer and have previously received investigational drugs with anti-tumor effects
Other illness
- 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.
Other
- Confirmed to be positive for HER2
- Judged by the investigators to be inappropriate for enrollment in this study
Who the study is looking for
- 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.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Minato-ku | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.