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Neoadjuvant Nivolumab for Operable Esophageal Carcinoma

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ClinicalTrials.gov Identifier: NCT03987815
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Samsung Medical Center

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Nivolumab for Operable Esophageal Squamous Cell Carcinoma
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Study Arm
Nivolumab 240 mg fixed dose every 2 weeks, for maximum of 3 cycles
Drug: Nivolumab
Nivolumab




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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987815


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 Not yet 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

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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03987815     History of Changes
Other Study ID Numbers: 2019-01-147-0004
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal 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
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents