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
Completed
- Conditions
- Esophageal Squamous Cell Carcinoma
- Interventions
- Biological: Nivolumab
- Registration Number
- NCT04936399
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 87
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1 Nivolumab Participants with Squamous Cell Oesophageal Carcinoma Receiving Nivolumab
- Primary Outcome Measures
Name Time Method Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Disease history At baseline 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 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 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: 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: 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: Gender 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: Treatment history At baseline Distribution of disease progression 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) every two weeks for 24 weeks post-treatment initiation following patient enrolment into the EAMS Up to 24 weeks 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: Underlying comorbidities 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 treatment patterns of nivolumab: Treatment duration Up to 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Local Institution - 0037
🇬🇧Bristol, United Kingdom
Local Institution
🇬🇧Walsall, United Kingdom
Local Institution - 0006
🇬🇧Truro, Cornwall, United Kingdom