Gastric CancerINGANCT05165264
A Study of Nivolumab Plus Chemotherapy in First Line Treatment of Adult Participants With Advanced or Metastatic Gastric Cancer
An observational study of Gastric Cancer, run by Bristol-Myers Squibb at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- How many people
- 600 participants
- Where
- 1 siteGermany
- Study dates
- 16 Feb 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include participants with previously untreated advanced or metastatic GC, GEJ adenocarcinoma or EAC that will be enrolled continuously.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Conditions
- Gastric Cancer
- Keywords
- OPDIVO®, Nivolumab, Advanced or Metastatic, Gastric Cancer, Prospective Study, Gastro-oesophageal junction, Oesophageal Cancer
- Medical subject headings
- Stomach Neoplasms, Neoplasm Metastasis, Esophageal Neoplasms
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 or metastatic gastric cancer (GC), gastro-oesophageal junction (GEJ) or oesophageal adenocarcinoma (EAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
Secondary outcomes (6)
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.
Measured: From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
Overall response rate (ORR)
Defined as investigator assessed complete response, partial response, stable disease, or progressive disease.
Measured: From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
Duration of response
Defined as time from response to progression
Measured: From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
Incidence of Adverse Events (AEs)
Measured: From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
Overall Survival (OS)
Defined as time since initial diagnosis and treatment with nivolumab until date of death due to any cause.
Measured: From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
OS measured by Programmed Death-Ligand 1 (PD-L1) combined positive score (CPS)
Measured: From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start16 Feb 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165264
- Sponsor's protocol ID
- CA209-8EC
- Acronym
- INGA
- Status last verified
- Feb 2025
- First submitted
- 8 Dec 2021
- Last updated
- 3 Mar 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05165264
- Acronym / sponsor ID
- INGA / CA209-8EC
- Conditions
- Gastric Cancer
- Keywords
- OPDIVO®, Nivolumab, Advanced or Metastatic, Gastric Cancer, Prospective Study, Gastro-oesophageal junction, Oesophageal Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Dec 2021 (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 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Participants with previously untreated advanced or metastatic gastric cancer (GC), gastro-oesophageal junction (GEJ) or oesophageal adenocarcinoma (EAC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include participants with previously untreated advanced or metastatic GC, GEJ adenocarcinoma or EAC that will be enrolled continuously.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
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
Overall Survival (OS)
Time frame: From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
6 secondary outcomes
Progression-free survival (PFS)
Time frame: From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
Overall response rate (ORR)
Time frame: From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
Duration of response
Time frame: From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
Incidence of Adverse Events (AEs)
Time frame: From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
Overall Survival (OS)
Time frame: From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
OS measured by Programmed Death-Ligand 1 (PD-L1) combined positive score (CPS)
Time frame: From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- BMS Clinical Trial InformationLink 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 Gastric Cancer, run by Bristol-Myers Squibb at 1 site in Germany.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 3 Mar 2025. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
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?
Overall Survival (OS) (time frame: From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months). 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 3 Mar 2025.