Clinical trial NCT04936399: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Survival
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-06-23
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Age
timeFrame: At baseline
measure: Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Gender
timeFrame: At baseline
measure: Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Race
timeFrame: At baseline
measure: Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Eastern Cooperative Oncology Group Performance Status (ECOG PS)
timeFrame: At baseline
measure: Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Condition which the product is being used for
timeFrame: At baseline
measure: Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Number of organs with metastases
timeFrame: At baseline
measure: Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Sites of metastasis
timeFrame: At baseline
measure: Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Prior surgery for oesophageal cancer
timeFrame: At baseline
measure: Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Underlying comorbidities
timeFrame: At baseline
measure: Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Concomitant medication
timeFrame: At baseline
measure: Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Weight
timeFrame: At baseline
measure: Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Disease history
timeFrame: At baseline
measure: Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Treatment history
timeFrame: At baseline
measure: Distribution of treatment patterns of nivolumab: Treatment duration
timeFrame: Up to 12 months
measure: Distribution of disease progression to determine progression free survival (PFS) based on data collected as part of routine care
timeFrame: Up to 12 months
measure: Distribution of disease progression to determine overall survival (OS) based on data collected as part of routine care
timeFrame: Up to 12 months
measure: Distribution of survival status to determine progression free survival (PFS) based on data collected as part of routine care
timeFrame: Up to 12 months
measure: Distribution of survival status to determine overall survival (OS) based on data collected as part of routine care
timeFrame: Up to 12 months
measure: Distribution of patient quality of life through EQ-5D-3L (EQ-5D) at baseline following patient enrolment into the EAMS
timeFrame: At baseline
measure: 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
timeFrame: Up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Truro
country: United Kingdom
facility: Local Institution - 0006
state: Cornwall
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Maidstone
country: United Kingdom
facility: Local Institution
state: Kent
city: Glasgow
country: United Kingdom
facility: Local Institution
state: Lanarkshire
city: Grimsby
country: United Kingdom
facility: Local Institution
state: Lincolnshire
city: Edinburgh
country: United Kingdom
facility: Local Institution
state: Scotland
city: Birmingham
country: United Kingdom
facility: Local Institution
state: West Midlands
city: Leeds
country: United Kingdom
facility: Local Institution
state: West Yorkshire
city: Basingstoke
country: United Kingdom
facility: Local Institution
city: Bebington
country: United Kingdom
facility: Local Institution
city: Belfast
country: United Kingdom
facility: Local Institution
city: Birmingham
country: United Kingdom
facility: Local Institution
city: Blackburn
country: United Kingdom
facility: Local Institution
city: Bristol
country: United Kingdom
facility: Local Institution - 0037
city: Cambridge
country: United Kingdom
facility: Local Institution
city: Cardiff
country: United Kingdom
facility: Local Institution
city: Cottingham
country: United Kingdom
facility: Local Institution
city: Coventry
country: United Kingdom
facility: Local Institution
city: Derby
country: United Kingdom
facility: Local Institution
city: Devon
country: United Kingdom
facility: Local Institution
city: Dundee
country: United Kingdom
facility: Local Institution
city: Headington
country: United Kingdom
facility: Local Institution
city: Lancaster
country: United Kingdom
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
city: Manchester
country: United Kingdom
facility: Local Institution
city: Melrose
country: United Kingdom
facility: Local Institution
city: Northwood
country: United Kingdom
facility: Local Institution
city: Nottingham
country: United Kingdom
facility: Local Institution
city: Pembrokeshire
country: United Kingdom
facility: Local Institution
city: Preston
country: United Kingdom
facility: Local Institution
city: Surrey
country: United Kingdom
facility: Local Institution
city: Surrey
country: United Kingdom
facility: Local Institution
city: Taunton
country: United Kingdom
facility: Local Institution
city: Walsall
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: