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出境医 / 临床实验 / Neoadjuvant Nivolumab for Operable Esophageal Carcinoma

Neoadjuvant Nivolumab for Operable Esophageal Carcinoma

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.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Drug: Nivolumab Phase 2

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Nivolumab for Operable Esophageal Squamous Cell Carcinoma
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : July 31, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Study Arm
Nivolumab 240 mg fixed dose every 2 weeks, for maximum of 3 cycles
 Drug: Nivolumab
Nivolumab
Outcome Measures
Primary Outcome Measures :
  1. Major pathologic response [ Time Frame: 2 months ]
    Viable tumor comprised ≤ 10% of resected tumor specimens


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 2 months ]
    Partial response is defined as a decrease by 30% or more in sums of longest diameter of measurable target lesions

  2. Positron Emission Tomography (PET)-CT response [ Time Frame: 2 months ]
    Complete metabolic response is defined as the SUV of 2.5 or less than 2.5 of primary tumor

  3. Progression-free survival (PFS) [ Time Frame: 24 months ]
    Time from the enrollment to disease relapse after complete resection or death from any cause

  4. Overall survival (OS) [ Time Frame: 24 months ]
    Time from the enrollment to death of any cause


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed esophageal squamous cell carcinoma
  2. Clinical stage T2N0 (invasion to muscularis propria) or T3N0 (invasion to adventitia)
  3. ECOG performance 0 or 1
  4. Age 19 years or older

Exclusion Criteria:

  1. Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer
  2. Ineligibility or contraindication for esophagectomy
  3. 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.
  4. 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).
  5. Has severe hypersensitivity and adverse events (≥Grade 3) to nivolumab and/or any PD-1/PD-L1 inhibitors.
Contacts and Locations

Contacts
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Contact: Jong-Mu Sun, Ph.D, MD 82-2-3410-3459 jongmu.sun@samsung.com

Locations
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Korea, Republic of
Jong-Mu Sun Recruiting
Seoul, Korea, Republic of, 06351
Contact: Jong-Mu Sun    82-2-3410-3459 ext 82-2-3410-3459    jongmu.sun@samsung.com   
Sponsors and Collaborators
Samsung Medical Center
Ono Pharmaceutical Co. Ltd
Investigators
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Principal Investigator: Jong-Mu Sun Samsung Medical Center
Tracking Information
First Submitted Date  ICMJE June 12, 2019
First Posted Date  ICMJE June 17, 2019
Last Update Posted Date December 17, 2020
Actual Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2019) 		Major pathologic response [ Time Frame: 2 months ]
Viable tumor comprised ≤ 10% of resected tumor specimens
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2019)
  • Objective response rate (ORR) [ Time Frame: 2 months ]
    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 [ Time Frame: 2 months ]
    Complete metabolic response is defined as the SUV of 2.5 or less than 2.5 of primary tumor
  • Progression-free survival (PFS) [ Time Frame: 24 months ]
    Time from the enrollment to disease relapse after complete resection or death from any cause
  • Overall survival (OS) [ Time Frame: 24 months ]
    Time from the enrollment to death of any cause
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neoadjuvant Nivolumab for Operable Esophageal Carcinoma
Official Title  ICMJE Neoadjuvant Nivolumab for Operable Esophageal Squamous Cell Carcinoma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Esophageal Squamous Cell Carcinoma
Intervention  ICMJE Drug: Nivolumab
Nivolumab
Study Arms  ICMJE Experimental: Study Arm
Nivolumab 240 mg fixed dose every 2 weeks, for maximum of 3 cycles
Intervention: Drug: Nivolumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 12, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histologically confirmed esophageal squamous cell carcinoma
  2. Clinical stage T2N0 (invasion to muscularis propria) or T3N0 (invasion to adventitia)
  3. ECOG performance 0 or 1
  4. Age 19 years or older

Exclusion Criteria:

  1. Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer
  2. Ineligibility or contraindication for esophagectomy
  3. 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.
  4. 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).
  5. Has severe hypersensitivity and adverse events (≥Grade 3) to nivolumab and/or any PD-1/PD-L1 inhibitors.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jong-Mu Sun, Ph.D, MD 82-2-3410-3459 jongmu.sun@samsung.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03987815
Other Study ID Numbers  ICMJE 2019-01-147-0004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Ono Pharmaceutical Co. Ltd
Investigators  ICMJE
Principal Investigator: Jong-Mu Sun Samsung Medical Center
PRS Account Samsung Medical Center
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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