Back to resultsNeoadjuvant Nivolumab for Operable Esophageal Carcinoma
Primary Purpose
Esophageal Squamous Cell Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Nivolumab
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed esophageal squamous cell carcinoma
- Clinical stage T2N0 (invasion to muscularis propria) or T3N0 (invasion to adventitia)
- ECOG performance 0 or 1
- Age 19 years or older
Exclusion Criteria:
- Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer
- Ineligibility or contraindication for esophagectomy
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
- Has severe hypersensitivity and adverse events (≥Grade 3) to nivolumab and/or any PD-1/PD-L1 inhibitors.
Sites / Locations
- Jong-Mu SunRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Arm
Arm Description
Nivolumab 240 mg fixed dose every 2 weeks, for maximum of 3 cycles
Outcomes
Primary Outcome Measures
Major pathologic response
Viable tumor comprised ≤ 10% of resected tumor specimens
Secondary Outcome Measures
Objective response rate (ORR)
Partial response is defined as a decrease by 30% or more in sums of longest diameter of measurable target lesions
Positron Emission Tomography (PET)-CT response
Complete metabolic response is defined as the SUV of 2.5 or less than 2.5 of primary tumor
Progression-free survival (PFS)
Time from the enrollment to disease relapse after complete resection or death from any cause
Overall survival (OS)
Time from the enrollment to death of any cause
Full Information
NCT ID
NCT03987815
First Posted
June 12, 2019
Last Updated
December 15, 2020
Sponsor
Samsung Medical Center
Collaborators
Ono Pharmaceutical Co. Ltd
1. Study Identification
Unique Protocol Identification Number
NCT03987815
Brief Title
Neoadjuvant Nivolumab for Operable Esophageal Carcinoma
Official Title
Neoadjuvant Nivolumab for Operable Esophageal Squamous Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
Collaborators
Ono Pharmaceutical Co. Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a single arm phase II study, in which maximum 3 cycles of nivolumab (240 mg fixed dose every 2 weeks) is administered for T2- or T3-node negative esophageal squamous cell carcinoma, before curative operation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study Arm
Arm Type
Experimental
Arm Description
Nivolumab 240 mg fixed dose every 2 weeks, for maximum of 3 cycles
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Intervention Description
Nivolumab
Primary Outcome Measure Information:
Title
Major pathologic response
Description
Viable tumor comprised ≤ 10% of resected tumor specimens
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Partial response is defined as a decrease by 30% or more in sums of longest diameter of measurable target lesions
Time Frame
2 months
Title
Positron Emission Tomography (PET)-CT response
Description
Complete metabolic response is defined as the SUV of 2.5 or less than 2.5 of primary tumor
Time Frame
2 months
Title
Progression-free survival (PFS)
Description
Time from the enrollment to disease relapse after complete resection or death from any cause
Time Frame
24 months
Title
Overall survival (OS)
Description
Time from the enrollment to death of any cause
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed esophageal squamous cell carcinoma
Clinical stage T2N0 (invasion to muscularis propria) or T3N0 (invasion to adventitia)
ECOG performance 0 or 1
Age 19 years or older
Exclusion Criteria:
Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer
Ineligibility or contraindication for esophagectomy
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
Has severe hypersensitivity and adverse events (≥Grade 3) to nivolumab and/or any PD-1/PD-L1 inhibitors.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jong-Mu Sun, Ph.D, MD
Phone
82-2-3410-3459
Email
jongmu.sun@samsung.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong-Mu Sun
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jong-Mu Sun
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong-Mu Sun
Phone
82-2-3410-3459
Ext
82-2-3410-3459
Email
jongmu.sun@samsung.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neoadjuvant Nivolumab for Operable Esophageal Carcinoma
We'll reach out to this number within 24 hrs