A Study of Participants With Squamous Cell Oesophageal Carcinoma Receiving Nivolumab as Part of an Early Access to Medicines Scheme (EAMS) Program in the United Kingdom

Study Overview
=================
Brief Summary
-----------------
This purpose of this observational study is to review medical chart and patient survey data collection within an early access to medicines scheme (EAMS) program. Participant who are eligible, provide consent and enroll into the squamous cell oesophageal cancer EAMS to receive Nivolumab will be included in this study.

Official Title
-----------------
Clinical Characteristics, Outcomes and Quality of Life in Patients With Squamous Cell Oesophageal Carcinoma Receiving Nivolumab After Prior Chemotherapy as Part of an Early Access to Medicines Scheme (EAMS) Program in the United Kingdom

Conditions
-----------------
Esophageal Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Biological: Nivolumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult participant (≥18 years of age) enrolling into the squamous cell (including adenosquamous) oesophageal cancer early access to medicines scheme (EAMS) and plans to initiate treatment with nivolumab Willing and able to comply with the study requirements and provide informed consent Exclusion Criteria: • Does not receive at least one dose of nivolumab as part of the EAMS Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Participants with Squamous Cell Oesophageal Carcinoma Receiving Nivolumab | Biological: Nivolumab<br>* Participants will receive Nivolumab after prior chemotherapy as part of an early access to medicines scheme (EAMS) program in the United Kingdom (UK)<br>* Other names: Opdivo®, BMS-936558;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Age |  | At baseline | 
| Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Gender |  | At baseline | 
| Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Race |  | At baseline | 
| Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Eastern Cooperative Oncology Group Performance Status (ECOG PS) |  | At baseline | 
| Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Condition which the product is being used for |  | At baseline | 
| Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Number of organs with metastases |  | At baseline | 
| Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Sites of metastasis |  | At baseline | 
| Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Prior surgery for oesophageal cancer |  | At baseline | 
| Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Underlying comorbidities |  | At baseline | 
| Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Concomitant medication |  | At baseline | 
| Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Weight |  | At baseline | 
| Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Disease history |  | At baseline | 
| Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Treatment history |  | At baseline | 
| Distribution of treatment patterns of nivolumab: Treatment duration |  | Up to 12 months | 
| Distribution of disease progression to determine progression free survival (PFS) based on data collected as part of routine care |  | Up to 12 months | 
| Distribution of disease progression to determine overall survival (OS) based on data collected as part of routine care |  | Up to 12 months | 
| Distribution of survival status to determine progression free survival (PFS) based on data collected as part of routine care |  | Up to 12 months | 
| Distribution of survival status to determine overall survival (OS) based on data collected as part of routine care |  | Up to 12 months | 
| Distribution of patient quality of life through EQ-5D-3L (EQ-5D) at baseline following patient enrolment into the EAMS |  | At baseline | 
| Distribution of patient quality of life through EQ-5D-3L (EQ-5D) every two weeks for 24 weeks post-treatment initiation following patient enrolment into the EAMS |  | Up to 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BMS-936558, Early Access to Medicines Scheme, EAMS, Nivolumab, Prospective Study, Quality of Life, Real World Evidence, Squamous Cell Oesophageal Carcinoma, Survival