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

NCT06504615 | Recruiting FDA Drug

• 1 other identifier: CA209-1408
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Gastric adenocarcinoma; Gastro-esophageal junction (GEJ) adenocarcinoma; Esophageal adenocarcinoma (EAC); Esophageal squamous cell carcinoma (ESCC)

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

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

Secondary Outcomes (22)

• 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

• 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

Study Arms (2)

Cohort 1

Participants with a diagnosis of gastric adenocarcinoma, gastro-esophageal junction adenocarcinoma or esophageal adenocarcinoma

Drug: nivolumab + chemotherapy

Cohort 2

Participants with a diagnosis of untreated, unresectable, advanced, recurrent, or metastatic esophageal squamous cell carcinoma

Drug: nivolumab + chemotherapy

Interventions

nivolumab + chemotherapy DRUG

As prescribed by the treating clinician, as per product label

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants in France diagnosed with Gastric Adenocarcinoma, Gastro-Esophageal Junction (GEJ) adenocarcinoma, Esophageal Adenocarcinoma (EAC) or Esophageal Squamous Cell Carcinoma (ESCC) and treated with nivolumab in combination with fluoropyrimidine- and platinum-based chemotherapy

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

KAPPA SANTE Institution

Paris, 75002, France

RECRUITING

Kappa Santé

Paris, France

NOT YET RECRUITING

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus; Esophageal Squamous Cell Carcinoma; Adenocarcinoma

Interventions

Nivolumab; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 17, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)