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

Recruiting

• Conditions: Esophageal Adenocarcinoma (EAC); Gastro-esophageal Junction Adenocarcinoma; Esophageal Squamous Cell Carcinoma (ESCC); Gastric Adenocarcinoma
• Interventions: Drug: nivolumab + chemotherapy

• Registration Number: NCT06504615
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-10
• Study First Posted: 2024-07-17
• Status Verified: 2024-12
• Study Start: 2024-12-10
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-13
• Primary Completion: 2028-08-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	nivolumab + chemotherapy	Participants with a diagnosis of gastric adenocarcinoma, gastro-esophageal junction adenocarcinoma or esophageal adenocarcinoma
Cohort 2	nivolumab + chemotherapy	Participants with a diagnosis of untreated, unresectable, advanced, recurrent, or metastatic esophageal squamous cell carcinoma

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

Secondary Outcome Measures

Name	Time	Method
Cause of death (where available)	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
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 failure of strategy (TFS)	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
Time to treatment discontinuation (TTD)	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
Second progression-free survival (PFS2)	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
Participant socio-demographics	Baseline
Participant treatment history	Baseline
Chemotherapy treatment regime	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 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
Duration of response (DOR)	Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Participant clinical characteristics	Baseline
Nivolumab treatment regime	Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Participant adverse events (AEs)	Up to 3 years

Trial Locations

Locations (2)

KAPPA SANTE Institution; 🇫🇷 Paris, France

Kappa Santé; 🇫🇷 Paris, France