Gastric Cancer
Conditions
Keywords
OPDIVO®, Nivolumab, Advanced or Metastatic, Gastric Cancer, Prospective Study, Gastro-oesophageal junction, Oesophageal Cancer
Brief 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).
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months | Defined as investigator assessed complete response, partial response, stable disease, or progressive disease. |
| Duration of response | From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months | Defined as time from response to progression |
| Progression-free survival (PFS) | From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months | 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. |
| Overall Survival (OS) | From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months | Defined as time since initial diagnosis and treatment with nivolumab until date of death due to any cause. |
| OS measured by Programmed Death-Ligand 1 (PD-L1) combined positive score (CPS) | 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) | From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months | — |
Countries
Germany
Outcome results
None listed