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

NCT04936399 | Completed

• 1 other identifier: CA209-76A
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 36

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.

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

Outcome Measures

Primary Outcomes (20)

• 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

Study Arms (1)

Cohort 1

Participants with Squamous Cell Oesophageal Carcinoma Receiving Nivolumab

Biological: Nivolumab

Interventions

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)

Also known as: Opdivo®, BMS-936558

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Does not receive at least one dose of nivolumab as part of the EAMS

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (36)

Local Institution - 0006

Truro, Cornwall, TR1 3LJ, United Kingdom

Location

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London, Greater London, NW3 2QG, United Kingdom

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Maidstone, Kent, ME16 9QQ, United Kingdom

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Glasgow, Lanarkshire, G75 8RG, United Kingdom

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Grimsby, Lincolnshire, DN332BA, United Kingdom

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Edinburgh, Scotland, EH4 2XU, United Kingdom

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Birmingham, West Midlands, B9 5SS, United Kingdom

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Leeds, West Yorkshire, LS9 7TF, United Kingdom

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Basingstoke, RG24 9NA, United Kingdom

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Bebington, CH63 4JY, United Kingdom

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Belfast, BT9 7AB, United Kingdom

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Birmingham, B15 2TH, United Kingdom

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Blackburn, BB2 3HH, United Kingdom

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Local Institution - 0037

Bristol, S2 8ED, United Kingdom

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Cambridge, CB2 2QQ, United Kingdom

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Cardiff, CF14 2TL, United Kingdom

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Cottingham, HU16 5JQ, United Kingdom

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Coventry, CV2 2DX, United Kingdom

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Derby, DE22 3NE, United Kingdom

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Devon, EX2 5DW, United Kingdom

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Dundee, DD1 9SY, United Kingdom

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Headington, OX3 7LE, United Kingdom

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Lancaster, LA1 4RP, United Kingdom

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London, EC1A 7BE, United Kingdom

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London, SE1 9RT, United Kingdom

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London, W6 8RF, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Melrose, TD6 9BS, United Kingdom

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Northwood, HA6 2RN, United Kingdom

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Nottingham, NG5 1PB, United Kingdom

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Pembrokeshire, SA61 2PZ, United Kingdom

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Preston, PR2 9HT, United Kingdom

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Surrey, GU2 7XX, United Kingdom

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Surrey, SM2 5PT, United Kingdom

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Taunton, TA1 5DA, United Kingdom

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Walsall, WS2 9PS, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• Pre-approval Access (PAA) Healthcare Practitioner Requests
• FDA Safety Alerts and Recalls
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 23, 2021
• Study Start: June 25, 2020
• Primary Completion: December 3, 2021
• Study Completion: December 3, 2021
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

GB (36)