Esophageal Squamous Cell Carcinoma
Conditions
Keywords
BMS-936558, Early Access to Medicines Scheme, EAMS, Nivolumab, Prospective Study, Quality of Life, Real World Evidence, Squamous Cell Oesophageal Carcinoma, Survival
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.
Interventions
BIOLOGICALNivolumab
Participants will receive Nivolumab after prior chemotherapy as part of an early access to medicines scheme (EAMS) program in the United Kingdom (UK)
Sponsors
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
* 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: 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: 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 |
Countries
United Kingdom
Outcome results
None listed