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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT04936399

Collaborator

(none)

Enrollment

Locations

17.3

Actual Duration (Months)

2.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Squamous Cell Carcinoma	Biological: Nivolumab

Study Design

Study Type:

Observational

Actual Enrollment :

87 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jun 25, 2020

Actual Primary Completion Date :

Dec 3, 2021

Actual Study Completion Date :

Dec 3, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution - 0006	Truro	Cornwall	United Kingdom	TR1 3LJ
2	Local Institution	London	Greater London	United Kingdom	NW3 2QG
3	Local Institution	Maidstone	Kent	United Kingdom	ME16 9QQ
4	Local Institution	Glasgow	Lanarkshire	United Kingdom	G75 8RG
5	Local Institution	Grimsby	Lincolnshire	United Kingdom	DN332BA
6	Local Institution	Edinburgh	Scotland	United Kingdom	EH4 2XU
7	Local Institution	Birmingham	West Midlands	United Kingdom	B9 5SS
8	Local Institution	Leeds	West Yorkshire	United Kingdom	LS9 7TF
9	Local Institution	Basingstoke		United Kingdom	RG24 9NA
10	Local Institution	Bebington		United Kingdom	CH63 4JY
11	Local Institution	Belfast		United Kingdom	BT9 7AB
12	Local Institution	Birmingham		United Kingdom	B15 2TH
13	Local Institution	Blackburn		United Kingdom	BB2 3HH
14	Local Institution - 0037	Bristol		United Kingdom	S2 8ED
15	Local Institution	Cambridge		United Kingdom	CB2 2QQ
16	Local Institution	Cardiff		United Kingdom	CF14 2TL
17	Local Institution	Cottingham		United Kingdom	HU16 5JQ
18	Local Institution	Coventry		United Kingdom	CV2 2DX
19	Local Institution	Derby		United Kingdom	DE22 3NE
20	Local Institution	Devon		United Kingdom	EX2 5DW
21	Local Institution	Dundee		United Kingdom	DD1 9SY
22	Local Institution	Headington		United Kingdom	OX3 7LE
23	Local Institution	Lancaster		United Kingdom	LA1 4RP
24	Local Institution	London		United Kingdom	EC1A 7BE
25	Local Institution	London		United Kingdom	SE1 9RT
26	Local Institution	London		United Kingdom	W6 8RF
27	Local Institution	Manchester		United Kingdom	M20 4BX
28	Local Institution	Melrose		United Kingdom	TD6 9BS
29	Local Institution	Northwood		United Kingdom	HA6 2RN
30	Local Institution	Nottingham		United Kingdom	NG5 1PB
31	Local Institution	Pembrokeshire		United Kingdom	SA61 2PZ
32	Local Institution	Preston		United Kingdom	PR2 9HT
33	Local Institution	Surrey		United Kingdom	GU2 7XX
34	Local Institution	Surrey		United Kingdom	SM2 5PT
35	Local Institution	Taunton		United Kingdom	TA1 5DA
36	Local Institution	Walsall		United Kingdom	WS2 9PS