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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 87
- Locations
- 3
- Primary Endpoint
- Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Disease history
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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/exclusion criteria apply
Outcomes
Primary Outcomes
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Disease history
Time Frame: At baseline
Distribution of disease progression to determine progression free survival (PFS) based on data collected as part of routine care
Time Frame: Up to 12 months
Distribution of survival status to determine progression free survival (PFS) based on data collected as part of routine care
Time Frame: Up to 12 months
Distribution of survival status to determine overall survival (OS) based on data collected as part of routine care
Time Frame: Up to 12 months
Distribution of patient quality of life through EQ-5D-3L (EQ-5D) at baseline following patient enrolment into the EAMS
Time Frame: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Age
Time Frame: 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
Time Frame: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Number of organs with metastases
Time Frame: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Concomitant medication
Time Frame: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Weight
Time Frame: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Gender
Time Frame: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Prior surgery for oesophageal cancer
Time Frame: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Treatment history
Time Frame: At baseline
Distribution of disease progression to determine overall survival (OS) based on data collected as part of routine care
Time Frame: Up to 12 months
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
Time Frame: Up to 24 weeks
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Sites of metastasis
Time Frame: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Underlying comorbidities
Time Frame: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Race
Time Frame: 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)
Time Frame: At baseline
Distribution of treatment patterns of nivolumab: Treatment duration
Time Frame: Up to 12 months
Secondary Outcomes
No secondary outcomes reported