Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04936399
  4. Details
NCT04936399 Clinical Trial

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

Esophageal Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04936399
Other study ID # CA209-76A
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 25, 2020
Est. completion date December 3, 2021

Study information
Verified date May 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 87
Est. completion date December 3, 2021
Est. primary completion date December 3, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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)

Locations
Country Name City State
United Kingdom Local Institution Basingstoke
United Kingdom Local Institution Bebington
United Kingdom Local Institution Belfast
United Kingdom Local Institution Birmingham
United Kingdom Local Institution Birmingham West Midlands
United Kingdom Local Institution Blackburn
United Kingdom Local Institution - 0037 Bristol
United Kingdom Local Institution Cambridge
United Kingdom Local Institution Cardiff
United Kingdom Local Institution Cottingham
United Kingdom Local Institution Coventry
United Kingdom Local Institution Derby
United Kingdom Local Institution Devon
United Kingdom Local Institution Dundee
United Kingdom Local Institution Edinburgh Scotland
United Kingdom Local Institution Glasgow Lanarkshire
United Kingdom Local Institution Grimsby Lincolnshire
United Kingdom Local Institution Headington
United Kingdom Local Institution Lancaster
United Kingdom Local Institution Leeds West Yorkshire
United Kingdom Local Institution London Greater London
United Kingdom Local Institution London
United Kingdom Local Institution London
United Kingdom Local Institution London
United Kingdom Local Institution Maidstone Kent
United Kingdom Local Institution Manchester
United Kingdom Local Institution Melrose
United Kingdom Local Institution Northwood
United Kingdom Local Institution Nottingham
United Kingdom Local Institution Pembrokeshire
United Kingdom Local Institution Preston
United Kingdom Local Institution Surrey
United Kingdom Local Institution Surrey
United Kingdom Local Institution Taunton
United Kingdom Local Institution - 0006 Truro Cornwall
United Kingdom Local Institution Walsall

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Age At baseline
Primary Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Gender At baseline
Primary Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Race At baseline
Primary 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
Primary 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
Primary Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Number of organs with metastases At baseline
Primary Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Sites of metastasis At baseline
Primary Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Prior surgery for oesophageal cancer At baseline
Primary Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Underlying comorbidities At baseline
Primary Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Concomitant medication At baseline
Primary Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Weight At baseline
Primary Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Disease history At baseline
Primary Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Treatment history At baseline
Primary Distribution of treatment patterns of nivolumab: Treatment duration Up to 12 months
Primary Distribution of disease progression to determine progression free survival (PFS) based on data collected as part of routine care Up to 12 months
Primary Distribution of disease progression to determine overall survival (OS) based on data collected as part of routine care Up to 12 months
Primary Distribution of survival status to determine progression free survival (PFS) based on data collected as part of routine care Up to 12 months
Primary Distribution of survival status to determine overall survival (OS) based on data collected as part of routine care Up to 12 months
Primary Distribution of patient quality of life through EQ-5D-3L (EQ-5D) at baseline following patient enrolment into the EAMS At baseline
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT06056336 - Perioperative Tislelizumab Plus Chemotherapy for Resectable Thoracic Oesophageal Squamous Cell Carcinoma Phase 2
Suspended NCT04084158 - A Study of Toripalimab Combined With Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma. Phase 2
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Not yet recruiting NCT05561699 - Sequential Preoperative Penpulimab Combined With Chemoradiotherapy(CRT) for Locally Advanced Esophageal Squamous Cell Cancer N/A
Active, not recruiting NCT04543617 - A Study of Atezolizumab With or Without Tiragolumab in Participants With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy Phase 3
Recruiting NCT06190782 - Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor Phase 3
Completed NCT05557955 - Identification of Breath Biomarkers in Esophageal Cancer
Recruiting NCT04045496 - A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors Phase 1
Recruiting NCT04584008 - Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics N/A
Not yet recruiting NCT03766178 - Study of Anti-PD-1 Antibody SHR-1210 Plus Nimotuzumab in the Treatment of Advanced Esophageal Squamous Cell Carcinoma Phase 2
Recruiting NCT02913066 - S-1 IMRT Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma Phase 2
Completed NCT02399306 - Chemoradiotherapy With or Without Enteral Nutrition for Locally Advanced Thoracic Esophageal Carcinoma Phase 3
Completed NCT01605305 - Study on FOLFOX6 as First-line Therapy to Treat Recurrent or Metastatic Esophageal Cancer Phase 2
Not yet recruiting NCT05552651 - Envafolimab Combined With Chemotherapy in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma Phase 2
Recruiting NCT05520619 - Combination of Tislelizumab and Chemoradiotherapy in Esophageal Cancer (EC-CRT-002) Phase 2
Terminated NCT03251417 - Apatinib and Irinotecan Combination Treatment in Unresectable or Metastatic Esophageal Squamous Cell Carcinoma Phase 2
Recruiting NCT05990231 - Cadonilimab/Anlotinib in Locally Advanced or Relapsed/Metastatic ESCC Patients After Failure of PD-1 Combined With Platinum-containing Chemotherapy Phase 2
Recruiting NCT04644250 - Combination of Toripalimab and Neoadjuvant Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma Phase 2
Completed NCT02916511 - Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy Concurrent With Chemotherapy for Esophageal Squamous Cell Carcinoma Phase 2
Terminated NCT04032704 - A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors Phase 2

External Links