Neoadjuvant Nivolumab for Operable Esophageal Carcinoma
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2019
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2019
CompletedFirst Posted
Study publicly available on registry
June 17, 2019
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2022
CompletedDecember 17, 2020
December 1, 2019
2.4 years
June 12, 2019
December 15, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Major pathologic response
Viable tumor comprised ≤ 10% of resected tumor specimens
2 months
Secondary Outcomes (4)
Objective response rate (ORR)
2 months
Positron Emission Tomography (PET)-CT response
2 months
Progression-free survival (PFS)
24 months
Overall survival (OS)
24 months
Study Arms (1)
Study Arm
EXPERIMENTALNivolumab 240 mg fixed dose every 2 weeks, for maximum of 3 cycles
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Samsung Medical Centerlead
- Ono Pharmaceutical Co. Ltdcollaborator
Study Sites (1)
Jong-Mu Sun
Seoul, 06351, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jong-Mu Sun
Samsung Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2019
First Posted
June 17, 2019
Study Start
August 1, 2019
Primary Completion
December 31, 2021
Study Completion
July 31, 2022
Last Updated
December 17, 2020
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share