A Study to Evaluate Nivolumab in the Treatment of Early Stage Esophageal or Gastroesophageal Cancer

Study Overview
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Brief Summary
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The purpose of this study is to describe the effectiveness and use of nivolumab after surgery in participants with early stage (Stage II/III) Esophageal Cancer/Gastroesophageal Junction Cancer (EC/GEJC).

Official Title
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Prospective Evaluation of Nivolumab in Adjuvant Esophageal Carcinoma/Gastroesophageal Junction Carcinoma: A Non-interventional Study

Conditions
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Esophageal Carcinoma, Gastroesophageal Junction Carcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Must provide voluntary informed consent to participate in the study before inclusion in the study Must have confirmed diagnosis of resected early stage (Stage II/III) EC or GEJC (histologically or cytologically confirmed stage) Physician decision to treat the participant with adjuvant nivolumab (according to the local label as per country-specific regulations) must be made prior to and independently of participation in the study Exclusion criteria: Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days (Participants who have completed their participation in an interventional trial and who are only followed-up for OS can be enrolled.) Prior treatment with immuno-oncologic agents, including nivolumab, for any indication Participants with a current primary diagnosis of a cancer other than EC or GEJC that requires systemic or other treatment, or has not been treated curatively (as per discretion of the investigator)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free Survival (DFS) |  | Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DFS in Subgroups of Interest |  | Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first | 
| DFS Rates in Subgroups of Interest |  | From baseline up to 42 months | 
| Overall Survival (OS) |  | Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first | 
| OS Rates |  | From baseline up to 42 months | 
| Progression-free Survival (PFS) |  | Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first | 
| PFS Rates |  | From baseline up to 42 months | 
| Distant Metastasis-free Survival (DMFS) |  | Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first | 
| DMFS Rates |  | From baseline up to 42 months | 
| Treatment Patterns of Adjuvant Nivolumab |  | From baseline up to 42 months | 
| Treatment Patterns of Subsequent Therapy |  | From baseline up to 42 months | 
| Post-recurrence Survival |  | Up to Month 42, death, lost to follow-up, or study withdrawal, whichever occurs first | 
| Time To Next Treatment |  | From baseline up to 42 months | 
| OS for Participants That Received Subsequent Nivolumab Treatment |  | Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first | 
| OS Rates for Participants That Received Subsequent Nivolumab Treatment |  | From baseline up to 42 months | 
| PFS for Participants That Received Subsequent Nivolumab Treatment |  | Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first | 
| PFS Rates for Participants That Received Subsequent Nivolumab Treatment |  | From baseline up to 42 months | 
| Overall Response Rate for Participants That Received Subsequent Nivolumab Treatment |  | From baseline up to 42 months | 
| Time to Disease Recurrence |  | From baseline up to 42 months | 
| Type of Disease Recurrence |  | From baseline up to 42 months | 
| Participant Sociodemographics |  | From baseline up to 42 months | 
| Number of Participants with Adverse Events |  | From baseline up to 42 months | 
| Number of Participants with Serious Adverse Events Related to Nivolumab Treatment |  | From baseline up to 42 months | 
| Disease stage at initial diagnosis | Esophageal Cancer/Gastroesophageal Junction Cancer (EC/GEJC) stage (i.e., I, II or III) and stage using Tumor, node, and metastasis (TNM) system | From baseline up to 42 months | 
| Eastern Cooperative Oncology Group (ECOG) performance status | 0: Fully active, able to carry on all pre-disease performance without restriction Restricted in physically strenuous activity but ambulatory and able to carry out work on a light or sedentary nature Ambulatory and capable of all self-care but unable to carry out work activities. Up and about more than 50% of waking hours Capable of only limited self-care, confined to bed or chair more than 50% of waking hours Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair Dead | From baseline up to 42 months | 
| Tumor location at initial diagnosis | EC (upper, middle, lower area of the esophagus) or GEJC (Siewert type I, II or III, if available) | From baseline up to 42 months | 
| Tumor histology at initial diagnosis | Squamous Cell Carcinoma (SSC) or adenocarcinoma | From baseline up to 42 months | 
| Pathologic lymph node status | ypN0, ypN1, ypN2, ypN3, unknown | From baseline up to 42 months | 
| Pathologic tumor status | ypT0, ypT1, ypT2, ypT3, ypT4, unknown | From baseline up to 42 months | 
| Tumor cell PD-L1 expression (≥1% vs. <1% vs. indeterminate/non-evaluable) | Tumor cell PD-L1 expression levels and cells assessed. This will be used to group PD-L1 expression into ≥1%, <1%, or Indeterminate/non-evaluable and to derive the combined positive score (CPS) score which is defined as PD-L1 positive tumor cells + PD-L1 positive mononuclear inflammatory cells)/Total tumor cells) × 100 | From baseline up to 42 months | 
| Type of recurrence | local/regional vs. distant | From baseline up to 42 months | 
| Serum levels of nuclear protein Ki67 |  | From baseline up to 42 months | 
| Number of participants with metastasis |  | From baseline up to 42 months | 
| Sites of metastases | Lung, brain, liver, peritoneum, bone, lymph nodes, other | From baseline up to 42 months | 
| Comorbidities | Diagnosis date and name of diagnosis, grouped using the National Cancer Institute (NCI) Comorbidity Index. | From baseline up to 42 months | 
| Concomitant treatments | Type of treatment or therapies receive in parallel of nivolumab treatment and details (e.g., medications, radiotherapy, chemotherapy, systemic therapy, or surgical treatment) | From baseline up to 42 months | 
| Concurrent medical conditions |  | From baseline up to 42 months | 
| Prior treatments for EC/GEJC | Type of therapies received prior to initiation of nivolumab treatment (e.g., radiotherapy, chemotherapy, targeted therapy, systemic treatment, platinum-based therapy) and details (if applicable, e.g., regimens, dosing | From baseline up to 42 months | 
| Participant Treatment History |  | From baseline up to 42 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nivolumab, Adjuvant, Post Marketing, Non-interventional