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Completed

NCT Number: 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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0006, Truro, Cornwall, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other names: Opdivo®, BMS-936558

Primary outcomes

  1. Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Age

    Time frame: At baseline

  2. Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Gender

    Time frame: At baseline

  3. Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Race

    Time frame: At baseline

  4. 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

  5. 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

  6. Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Number of organs with metastases

    Time frame: At baseline

  7. Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Sites of metastasis

    Time frame: At baseline

  8. Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Prior surgery for oesophageal cancer

    Time frame: At baseline

  9. Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Underlying comorbidities

    Time frame: At baseline

  10. Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Concomitant medication

    Time frame: At baseline

  11. Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Weight

    Time frame: At baseline

  12. Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Disease history

    Time frame: At baseline

  13. Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Treatment history

    Time frame: At baseline

  14. Distribution of treatment patterns of nivolumab: Treatment duration

    Time frame: Up to 12 months

  15. 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

  16. Distribution of disease progression to determine overall survival (OS) based on data collected as part of routine care

    Time frame: Up to 12 months

  17. 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

  18. Distribution of survival status to determine overall survival (OS) based on data collected as part of routine care

    Time frame: Up to 12 months

  19. Distribution of patient quality of life through EQ-5D-3L (EQ-5D) at baseline following patient enrolment into the EAMS

    Time frame: At baseline

  20. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 23, 2021
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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