Esophageal Carcinoma, Gastroesophageal Junction Carcinoma
Conditions
Keywords
Nivolumab, Adjuvant, Post Marketing, Non-interventional
Brief summary
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).
Interventions
None listed
Sponsors
PPD Development, LP
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
1. Must provide voluntary informed consent to participate in the study before inclusion in the study 2. Must have confirmed diagnosis of resected early stage (Stage II/III) EC or GEJC (histologically or cytologically confirmed stage) 3. 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
1. 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.) 2. Prior treatment with immuno-oncologic agents, including nivolumab, for any indication 3. 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free Survival (DFS) | Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| Number of Participants with Adverse Events | From baseline up to 42 months | — |
| Overall Response Rate 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 | — |
| Disease stage at initial diagnosis | From baseline up to 42 months | Esophageal Cancer/Gastroesophageal Junction Cancer (EC/GEJC) stage (i.e., I, II or III) and stage using Tumor, node, and metastasis (TNM) system |
| Eastern Cooperative Oncology Group (ECOG) performance status | From baseline up to 42 months | 0: Fully active, able to carry on all pre-disease performance without restriction 1. Restricted in physically strenuous activity but ambulatory and able to carry out work on a light or sedentary nature 2. Ambulatory and capable of all self-care but unable to carry out work activities. Up and about more than 50% of waking hours 3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours 4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair 5. Dead |
| Tumor location at initial diagnosis | From baseline up to 42 months | EC (upper, middle, lower area of the esophagus) or GEJC (Siewert type I, II or III, if available) |
| Tumor histology at initial diagnosis | From baseline up to 42 months | Squamous Cell Carcinoma (SSC) or adenocarcinoma |
| Pathologic lymph node status | From baseline up to 42 months | ypN0, ypN1, ypN2, ypN3, unknown |
| Pathologic tumor status | From baseline up to 42 months | ypT0, ypT1, ypT2, ypT3, ypT4, unknown |
| Tumor cell PD-L1 expression (≥1% vs. <1% vs. indeterminate/non-evaluable) | From baseline up to 42 months | 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 |
| Type of recurrence | From baseline up to 42 months | local/regional vs. distant |
| 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 | From baseline up to 42 months | Lung, brain, liver, peritoneum, bone, lymph nodes, other |
| Comorbidities | From baseline up to 42 months | Diagnosis date and name of diagnosis, grouped using the National Cancer Institute (NCI) Comorbidity Index. |
| Concomitant treatments | From baseline up to 42 months | Type of treatment or therapies receive in parallel of nivolumab treatment and details (e.g., medications, radiotherapy, chemotherapy, systemic therapy, or surgical treatment) |
| Concurrent medical conditions | From baseline up to 42 months | — |
| Prior treatments for EC/GEJC | From baseline up to 42 months | 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 |
| Participant Treatment History | From baseline up to 42 months | — |
| Number of Participants with Serious Adverse Events Related to Nivolumab Treatment | From baseline up to 42 months | — |
Countries
Germany, United States
Outcome results
None listed