Clinical trial NCT06504615: Observational Study of Patients Treated With Nivolumab and Chemotherapy for Advanced or Metastatic Esophageal, Gastroesophageal or Gastric Cancer in France
Official title: A French, Prospective, Observational, Multicenter Study of Patients Treated With Nivolumab Plus Chemotherapy as First Line Treatment in Advanced or Metastatic Esophageal Squamous Cell Carcinoma, Esophageal Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma or Gastric Adenocarcinoma [METAGIO]
Study type: OBSERVATIONAL
Overall status: RECRUITING
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)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-07-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Secondary outcomes:
measure: Cause of death (where available)
timeFrame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
measure: Disease progression
timeFrame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
measure: Progression-free survival (PFS)
timeFrame: Day 0 and months 2, 3, 4-6, 8-9, 12, 18, 24, 30 and 36
measure: Time to treatment discontinuation (TTD)
timeFrame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
measure: Time to failure of strategy (TFS)
timeFrame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
measure: Time to next Treatment (TTNT)
timeFrame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
measure: Second progression-free survival (PFS2)
timeFrame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
measure: Treatment Free Interval (TFI)
timeFrame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
measure: Overall tumor response (ORR)
timeFrame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
measure: Response rate
timeFrame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
measure: Duration of response (DOR)
timeFrame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
measure: Participant socio-demographics
timeFrame: Baseline
measure: Participant clinical characteristics
timeFrame: Baseline
measure: Participant treatment history
timeFrame: Baseline
measure: Nivolumab treatment regime
timeFrame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
measure: Chemotherapy treatment regime
timeFrame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
measure: Reason for treatment discontinuation
timeFrame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
measure: Subsequent non-systemic treatment received post first-line treatment
timeFrame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
measure: Subsequent systemic treatment received post first-line treatment
timeFrame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
measure: Subsequent systemic treatment effectiveness
timeFrame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
measure: Participant adverse events (AEs)
timeFrame: Up to 3 years
measure: Participant health related quality of life as assessed by 5-level EuroQoL-5 dimension version (EQ-5D-5L)
timeFrame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Other outcomes:
Locations:
city: Paris
country: France
facility: KAPPA SANTE Institution
city: Paris
country: France
facility: Kappa Santé
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: