Observational Study of Patients Treated With Nivolumab and Chemotherapy for Advanced or Metastatic Esophageal, Gastroesophageal or Gastric Cancer in France

Bristol-Myers Squibb500 enrolled

Overview

A study to estimate the overall survival in real-life conditions in France of adult participants treated with nivolumab in combination with chemotherapy as first-line treatment for gastric and gastroesophageal junction cancer.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Gastric Adenocarcinoma Gastro-esophageal Junction Adenocarcinoma Esophageal Adenocarcinoma (EAC)Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

nivolumab + chemotherapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Cohorts 1 \& 2 * Adult participants (at least 18 years of age at time of treatment decision) * Participants treated with nivolumab in combination with fluoropyrimidine- and platinum-based chemotherapy (according to the French current marketing authorization) for the treatment of Gastric Adenocarcinoma, Gastro-Esophageal Junction (GEJ) adenocarcinoma, Esophageal Adenocarcinoma (EAC) or Esophageal Squamous Cell Carcinoma (ESCC) and prior to study participation. * Participants who provided oral informed consent to participate in the study Cohort 1 only • Diagnosis of untreated HER2 negative advanced or metastatic gastric adenocarcinoma, GEJ adenocarcinoma or EAC whose tumor express PD-L1 with a CPS ≥5 Cohort 2 only • Diagnosis of untreated unresectable advanced, recurrent or metastatic ESCC with tumor cell PD-L1 expression (TPS) ≥1% Exclusion Criteria: Cohorts 1 \& 2 * Participants with a primary diagnosis of a cancer other than advanced or metastatic gastric adenocarcinoma, GEJ adenocarcinoma, EAC or ESCC, within the past 5 years. * Participants currently enrolled in an interventional clinical trial for his/her advanced or metastatic gastric adenocarcinoma, GEJ adenocarcinoma, EAC or ESCC. * Pregnant women * Participants under guardianship

Outcomes

Primary Outcomes

Overall survival (OS)

Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

Secondary Outcomes

Cause of death (where available)

Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

Disease progression

As assessed by the Site Investigator

Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

Progression-free survival (PFS)

Time frame: Day 0 and months 2, 3, 4-6, 8-9, 12, 18, 24, 30 and 36

Time to treatment discontinuation (TTD)

Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

Time to failure of strategy (TFS)

Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

Time to next Treatment (TTNT)

Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

Second progression-free survival (PFS2)

Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

Treatment Free Interval (TFI)

Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

Overall tumor response (ORR)

Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

Response rate

Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

Duration of response (DOR)

Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

Participant socio-demographics

Time frame: Baseline

Participant clinical characteristics

Time frame: Baseline

Participant treatment history

Time frame: Baseline

Nivolumab treatment regime

Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

Chemotherapy treatment regime

Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

Reason for treatment discontinuation

Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

Subsequent non-systemic treatment received post first-line treatment

Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

Subsequent systemic treatment received post first-line treatment

Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

Subsequent systemic treatment effectiveness

Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

Participant adverse events (AEs)

Time frame: Up to 3 years

Participant health related quality of life as assessed by 5-level EuroQoL-5 dimension version (EQ-5D-5L)

Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

Observational Study of Patients Treated With Nivolumab and Chemotherapy for Advanced or Metastatic Esophageal, Gastroesophageal or Gastric Cancer in France

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts