Esophageal Squamous Cell CarcinomaPhase 2NCT03987815
Neoadjuvant Nivolumab for Operable Esophageal Carcinoma
A Phase 2 study testing Nivolumab in people with Esophageal Squamous Cell Carcinoma, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2019to 31 Jul 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Jong-Mu Sun
Seoul, 06351
Jong-Mu Sun, 82-2-3410-3459 ext. 82-2-3410-3459, jongmu.sun@samsung.com
About this study
Official title: Neoadjuvant Nivolumab for Operable Esophageal Squamous Cell Carcinoma
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.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Nivolumab
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Nivolumab
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | Nivolumab 240 mg fixed dose every 2 weeks, for maximum of 3 cycles Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathologic response
Viable tumor comprised ≤ 10% of resected tumor specimens
Measured: 2 months
Secondary outcomes (4)
Objective response rate (ORR)
Partial response is defined as a decrease by 30% or more in sums of longest diameter of measurable target lesions
Measured: 2 months
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
Measured: 2 months
Progression-free survival (PFS)
Time from the enrollment to disease relapse after complete resection or death from any cause
Measured: 24 months
Overall survival (OS)
Time from the enrollment to death of any cause
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start1 Aug 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Jong-Mu Sun, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987815
- Sponsor's protocol ID
- 2019-01-147-0004
- Status last verified
- Dec 2019
- First submitted
- 12 Jun 2019
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Nivolumab for Operable Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03987815
- Acronym / sponsor ID
- 2019-01-147-0004
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 17 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Drug: NivolumabNivolumab 240 mg fixed dose every 2 weeks, for maximum of 3 cycles |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabNivolumab | Drug | Study Arm |
Primary outcome
Major pathologic response
Time frame: 2 months
Viable tumor comprised ≤ 10% of resected tumor specimens
4 secondary outcomes
Objective response rate (ORR)
Time frame: 2 months
Positron Emission Tomography (PET)-CT response
Time frame: 2 months
Progression-free survival (PFS)
Time frame: 24 months
Overall survival (OS)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong-Mu Sun principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab in people with Esophageal Squamous Cell Carcinoma, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jong-Mu Sun, Ph.D, MD (82-2-3410-3459, jongmu.sun@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathologic response (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.