Clinical trial NCT05165264: A Study of Nivolumab Plus Chemotherapy in First Line Treatment of Adult Participants With Advanced or Metastatic Gastric Cancer
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gastric Cancer
Keywords: OPDIVO®
Nivolumab
Advanced or Metastatic
Gastric Cancer
Prospective Study
Gastro-oesophageal junction
Oesophageal Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-12-21
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include participants with previously untreated advanced or metastatic GC, GEJ adenocarcinoma or EAC that will be enrolled continuously.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
measure: Overall response rate (ORR)
timeFrame: From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
measure: Duration of response
timeFrame: From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
measure: Incidence of Adverse Events (AEs)
timeFrame: From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
measure: Overall Survival (OS)
timeFrame: From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
measure: OS measured by Programmed Death-Ligand 1 (PD-L1) combined positive score (CPS)
timeFrame: From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Local Institution - 0001
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: