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

May 18, 2022 updated by: Bristol-Myers Squibb

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

87

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Basingstoke, United Kingdom, RG24 9NA
        • Local Institution
      • Bebington, United Kingdom, CH63 4JY
        • Local Institution
      • Belfast, United Kingdom, BT9 7AB
        • Local Institution
      • Birmingham, United Kingdom, B15 2TH
        • Local Institution
      • Blackburn, United Kingdom, BB2 3HH
        • Local Institution
      • Bristol, United Kingdom, S2 8ED
        • Local Institution - 0037
      • Cambridge, United Kingdom, CB2 2QQ
        • Local Institution
      • Cardiff, United Kingdom, CF14 2TL
        • Local Institution
      • Cottingham, United Kingdom, HU16 5JQ
        • Local Institution
      • Coventry, United Kingdom, CV2 2DX
        • Local Institution
      • Derby, United Kingdom, DE22 3NE
        • Local Institution
      • Devon, United Kingdom, EX2 5DW
        • Local Institution
      • Dundee, United Kingdom, DD1 9SY
        • Local Institution
      • Headington, United Kingdom, OX3 7LE
        • Local Institution
      • Lancaster, United Kingdom, LA1 4RP
        • Local Institution
      • London, United Kingdom, SE1 9RT
        • Local Institution
      • London, United Kingdom, EC1A 7BE
        • Local Institution
      • London, United Kingdom, W6 8RF
        • Local Institution
      • Manchester, United Kingdom, M20 4BX
        • Local Institution
      • Melrose, United Kingdom, TD6 9BS
        • Local Institution
      • Northwood, United Kingdom, HA6 2RN
        • Local Institution
      • Nottingham, United Kingdom, NG5 1PB
        • Local Institution
      • Pembrokeshire, United Kingdom, SA61 2PZ
        • Local Institution
      • Preston, United Kingdom, PR2 9HT
        • Local Institution
      • Surrey, United Kingdom, SM2 5PT
        • Local Institution
      • Surrey, United Kingdom, GU2 7XX
        • Local Institution
      • Taunton, United Kingdom, TA1 5DA
        • Local Institution
      • Walsall, United Kingdom, WS2 9PS
        • Local Institution
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • Local Institution - 0006
    • Greater London
      • London, Greater London, United Kingdom, NW3 2QG
        • Local Institution
    • Kent
      • Maidstone, Kent, United Kingdom, ME16 9QQ
        • Local Institution
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G75 8RG
        • Local Institution
    • Lincolnshire
      • Grimsby, Lincolnshire, United Kingdom, DN332BA
        • Local Institution
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH4 2XU
        • Local Institution
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B9 5SS
        • Local Institution
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Age
Time Frame: At baseline
At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Gender
Time Frame: At baseline
At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Race
Time Frame: At baseline
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
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
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
At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Sites of metastasis
Time Frame: At baseline
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
At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Underlying comorbidities
Time Frame: At baseline
At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Concomitant medication
Time Frame: At baseline
At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Weight
Time Frame: At baseline
At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Disease history
Time Frame: At baseline
At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Treatment history
Time Frame: At baseline
At baseline
Distribution of treatment patterns of nivolumab: Treatment duration
Time Frame: Up to 12 months
Up to 12 months
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
Up to 12 months
Distribution of disease progression to determine overall survival (OS) based on data collected as part of routine care
Time Frame: Up to 12 months
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
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
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
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
Time Frame: Up to 24 weeks
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2020

Primary Completion (Actual)

December 3, 2021

Study Completion (Actual)

December 3, 2021

Study Registration Dates

First Submitted

June 21, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (Actual)

June 23, 2021

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-76A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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