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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants with Squamous Cell Oesophageal Carcinoma Receiving Nivolumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological | Participants will receive Nivolumab after prior chemotherapy as part of an early access to medicines scheme (EAMS) program in the United Kingdom (UK) |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
• Does not receive at least one dose of nivolumab as part of the EAMS
Other protocol-defined inclusion/exclusion criteria apply
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This is an observational study consisting of medical chart review and patient survey data collection within an early access to medicines scheme (EAMS) program. Participants who are eligible, provide consent and enroll into the squamous cell oesophageal Cancer EAMS to receive nivolumab will be included in this study. The total number of patients and sites will be dependent on the number of requests for patient enrolment submitted to BMS from physicians. Pseudo-anonymized data on patient and disease characteristics, medical and oesophageal cancer treatment history, and nivolumab treatment patterns will be collected from patient medical charts and entered into an electronic data capture (EDC) system.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0006 | Truro | Cornwall | TR1 3LJ | United Kingdom | ||
| Local Institution |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Pre-approval Access (PAA) Healthcare Practitioner Requests | View source |
| FDA Safety Alerts and Recalls |
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|
| 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 |
| London |
| Greater London |
| NW3 2QG |
| United Kingdom |
| Local Institution | Maidstone | Kent | ME16 9QQ | United Kingdom |
| Local Institution | Glasgow | Lanarkshire | G75 8RG | United Kingdom |
| Local Institution | Grimsby | Lincolnshire | DN332BA | United Kingdom |
| Local Institution | Edinburgh | Scotland | EH4 2XU | United Kingdom |
| Local Institution | Birmingham | West Midlands | B9 5SS | United Kingdom |
| Local Institution | Leeds | West Yorkshire | LS9 7TF | United Kingdom |
| Local Institution | Basingstoke | RG24 9NA | United Kingdom |
| Local Institution | Bebington | CH63 4JY | United Kingdom |
| Local Institution | Belfast | BT9 7AB | United Kingdom |
| Local Institution | Birmingham | B15 2TH | United Kingdom |
| Local Institution | Blackburn | BB2 3HH | United Kingdom |
| Local Institution - 0037 | Bristol | S2 8ED | United Kingdom |
| Local Institution | Cambridge | CB2 2QQ | United Kingdom |
| Local Institution | Cardiff | CF14 2TL | United Kingdom |
| Local Institution | Cottingham | HU16 5JQ | United Kingdom |
| Local Institution | Coventry | CV2 2DX | United Kingdom |
| Local Institution | Derby | DE22 3NE | United Kingdom |
| Local Institution | Devon | EX2 5DW | United Kingdom |
| Local Institution | Dundee | DD1 9SY | United Kingdom |
| Local Institution | Headington | OX3 7LE | United Kingdom |
| Local Institution | Lancaster | LA1 4RP | United Kingdom |
| Local Institution | London | EC1A 7BE | United Kingdom |
| Local Institution | London | SE1 9RT | United Kingdom |
| Local Institution | London | W6 8RF | United Kingdom |
| Local Institution | Manchester | M20 4BX | United Kingdom |
| Local Institution | Melrose | TD6 9BS | United Kingdom |
| Local Institution | Northwood | HA6 2RN | United Kingdom |
| Local Institution | Nottingham | NG5 1PB | United Kingdom |
| Local Institution | Pembrokeshire | SA61 2PZ | United Kingdom |
| Local Institution | Preston | PR2 9HT | United Kingdom |
| Local Institution | Surrey | GU2 7XX | United Kingdom |
| Local Institution | Surrey | SM2 5PT | United Kingdom |
| Local Institution | Taunton | TA1 5DA | United Kingdom |
| Local Institution | Walsall | WS2 9PS | United Kingdom |
| View source |
| BMS Clinical Trial Patient Recruiting | View source |
| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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