Esophageal Squamous Cell CarcinomaNCT04936399
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
An observational study of Esophageal Squamous Cell Carcinoma, run by Bristol-Myers Squibb at 36 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Nivolumab
- How many people
- 87 participants
- Where
- 36 sitesUnited Kingdom
- Study dates
- 25 Jun 2020to 3 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Does not receive at least one dose of nivolumab as part of the EAMS
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United Kingdom36 sites
Local Institution
Basingstoke, RG24 9NA
Local Institution
Bebington, CH63 4JY
Local Institution
Belfast, BT9 7AB
Local Institution
Birmingham, West Midlands, B9 5SS
Local Institution
Birmingham, B15 2TH
Local Institution
Blackburn, BB2 3HH
Local Institution - 0037
Bristol, S2 8ED
Local Institution
Cambridge, CB2 2QQ
Local Institution
Cardiff, CF14 2TL
Local Institution
Cottingham, HU16 5JQ
Local Institution
Coventry, CV2 2DX
Local Institution
Derby, DE22 3NE
Local Institution
Devon, EX2 5DW
Local Institution
Dundee, DD1 9SY
Local Institution
Edinburgh, Scotland, EH4 2XU
Local Institution
Glasgow, Lanarkshire, G75 8RG
Local Institution
Grimsby, Lincolnshire, DN332BA
Local Institution
Headington, OX3 7LE
Local Institution
Lancaster, LA1 4RP
Local Institution
Leeds, West Yorkshire, LS9 7TF
Local Institution
London, Greater London, NW3 2QG
Local Institution
London, EC1A 7BE
Local Institution
London, SE1 9RT
Local Institution
London, W6 8RF
Local Institution
Maidstone, Kent, ME16 9QQ
Local Institution
Manchester, M20 4BX
Local Institution
Melrose, TD6 9BS
Local Institution
Northwood, HA6 2RN
Local Institution
Nottingham, NG5 1PB
Local Institution
Pembrokeshire, SA61 2PZ
Local Institution
Preston, PR2 9HT
Local Institution
Surrey, GU2 7XX
Local Institution
Surrey, SM2 5PT
Local Institution
Taunton, TA1 5DA
Local Institution - 0006
Truro, Cornwall, TR1 3LJ
Local Institution
Walsall, WS2 9PS
About this study
Official title: 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.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Nivolumab
- Keywords
- BMS-936558, Early Access to Medicines Scheme, EAMS, Nivolumab, Prospective Study, Quality of Life, Real World Evidence, Squamous Cell Oesophageal Carcinoma, Survival
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabBiological
Also called Opdivo®, BMS-936558
Participants will receive Nivolumab after prior chemotherapy as part of an early access to medicines scheme (EAMS) program in the United Kingdom (UK)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants with Squamous Cell Oesophageal Carcinoma Receiving Nivolumab Receives: Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Age
Measured: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Gender
Measured: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Race
Measured: 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)
Measured: 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
Measured: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Number of organs with metastases
Measured: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Sites of metastasis
Measured: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Prior surgery for oesophageal cancer
Measured: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Underlying comorbidities
Measured: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Concomitant medication
Measured: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Weight
Measured: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Disease history
Measured: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Treatment history
Measured: At baseline
Distribution of treatment patterns of nivolumab: Treatment duration
Measured: Up to 12 months
Distribution of disease progression to determine progression free survival (PFS) based on data collected as part of routine care
Measured: Up to 12 months
Distribution of disease progression to determine overall survival (OS) based on data collected as part of routine care
Measured: Up to 12 months
Distribution of survival status to determine progression free survival (PFS) based on data collected as part of routine care
Measured: Up to 12 months
Distribution of survival status to determine overall survival (OS) based on data collected as part of routine care
Measured: Up to 12 months
Distribution of patient quality of life through EQ-5D-3L (EQ-5D) at baseline following patient enrolment into the EAMS
Measured: 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
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start25 Jun 2020
- Primary completion3 Dec 2021
- Study completion3 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936399
- Sponsor's protocol ID
- CA209-76A
- Status last verified
- May 2022
- First submitted
- 21 Jun 2021
- Last updated
- 25 May 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04936399
- Acronym / sponsor ID
- CA209-76A
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- BMS-936558, Early Access to Medicines Scheme, EAMS, Nivolumab, Prospective Study, Quality of Life, Real World Evidence, Squamous Cell Oesophageal Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 3 Dec 2021 (actual)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Biological: NivolumabParticipants with Squamous Cell Oesophageal Carcinoma Receiving Nivolumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Does not receive at least one dose of nivolumab as part of the EAMS
- Other protocol-defined inclusion/exclusion criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: Opdivo®, BMS-936558Participants will receive Nivolumab after prior chemotherapy as part of an early access to medicines scheme (EAMS) program in the United Kingdom (UK) | Biological | Cohort 1 |
Primary outcome
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: Gender
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 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: Sites of metastasis
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: Underlying comorbidities
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: Disease history
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 treatment patterns of nivolumab: Treatment duration
Time frame: 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
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 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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Squamous Cell Carcinoma, run by Bristol-Myers Squibb at 36 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Age (time frame: At baseline). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.