Esophageal Adenocarcinoma (EAC), Esophageal Squamous Cell Carcinoma (ESCC), Gastric Adenocarcinoma, Gastro-esophageal Junction Adenocarcinoma
Conditions
Keywords
Gastric adenocarcinoma, Gastro-esophageal junction (GEJ) adenocarcinoma, Esophageal adenocarcinoma (EAC), Esophageal squamous cell carcinoma (ESCC)
Brief summary
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.
Interventions
As prescribed by the treating clinician, as per product label
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cause of death (where available) | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 | — |
| Disease progression | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 | As assessed by the Site Investigator |
| Progression-free survival (PFS) | Day 0 and months 2, 3, 4-6, 8-9, 12, 18, 24, 30 and 36 | — |
| Time to treatment discontinuation (TTD) | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 | — |
| Time to failure of strategy (TFS) | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 | — |
| Time to next Treatment (TTNT) | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 | — |
| Second progression-free survival (PFS2) | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 | — |
| Treatment Free Interval (TFI) | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 | — |
| Overall tumor response (ORR) | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 | — |
| Response rate | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 | — |
| Duration of response (DOR) | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 | — |
| Participant socio-demographics | Baseline | — |
| Participant clinical characteristics | Baseline | — |
| Participant treatment history | Baseline | — |
| Nivolumab treatment regime | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 | — |
| Chemotherapy treatment regime | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 | — |
| Reason for treatment discontinuation | 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 | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 | — |
| Subsequent systemic treatment received post first-line treatment | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 | — |
| Subsequent systemic treatment effectiveness | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 | — |
| Participant adverse events (AEs) | Up to 3 years | — |
| Participant health related quality of life as assessed by 5-level EuroQoL-5 dimension version (EQ-5D-5L) | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 | — |
Countries
France
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed