Clinical trial NCT05334719: A Study of the Effectiveness and Safety of Nivolumab Plus Chemotherapy in Participants With Untreated Advanced/Recurrent Gastric Cancer
Official title: A Non-interventional Observational Study of Effectiveness and Safety of Nivolumab Plus Chemotherapy for Untreated Advanced / Recurrent Gastric Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Stomach Neoplasms
Keywords: Nivolumab
Advanced or Recurrent
Gastric Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2022-04-19
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

Detailed description: The Time Perspective for this observational study is defined as 'Retrospective and Prospective'.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to approximately 4 years
measure: Objective response rate (ORR)
timeFrame: Up to approximately 4 years
measure: Incidence of all immune-related adverse events (irAE) according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
timeFrame: Up to approximately 4 years
measure: Incidence of treatment-related adverse events (TRAE) that have led to treatment discontinuation
timeFrame: Up to approximately 4 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up to approximately 4 years
measure: Duration of response (DOR)
timeFrame: Up to approximately 4 years
measure: Duration of treatment (DOT)
timeFrame: Up to approximately 4 years
measure: Time to next treatment (TNT)
timeFrame: Up to approximately 4 years
measure: Number of participants who have received subsequent therapy
timeFrame: Up to approximately 4 years
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to approximately 4 years
Other outcomes:
Locations:
city: Minato-ku
country: Japan
facility: Local Institution - 0001
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: