Metastatic Breast CancerPhase 1/2KORNELIANCT04061863
Nivolumab and Eribulin in HER2 Negative Metastatic Breast Cancer
A Phase 1/2 study testing Nivolumab in people with Metastatic Breast Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Cancer therapeutics such as chemotherapy may modulate tumor/immune-system interactions in favor of the immune system. Chemotherapy can result in tumor cell death with a resultant increase in tumor antigen delivery to antigen-presenting cells. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2019to Dec 2022
- Phase
- Phase 1/2
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures
- Age 20 years or older
- ECOG performance status(PS) 0 or 1
- Histologically confirmed stage IV or recurrent breast cancer
- HER2 negative disease: not eligible for anti-HER2 therapy
- HER2 negative [IHC 0, 1+ or IHC 2+ with corresponding ISH non-amplified or ratio less than 2.0 or ISH non-amplified ratio less than 2.0] as per ASCO-CAP HER2 guideline recommendations 2013 (ASCO-CAP)
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- Patients previously treated with anthracycline and/or taxane unless contraindicated; Patients who received anthracycline and/or taxane based chemotherapy in either the neoadjuvant, adjuvant or metastatic setting and experienced disease progression on or after taxane-based chemotherapy in the metastatic setting
- No more than 3 prior lines of cytotoxic chemotherapy for metastatic disease; patients who experienced disease recurrence within 1 year after completion of (neo)adjuvant anthracycline and taxane-based chemotherapy will be counted as 1 prior line of treatment.; hormonal therapy will not be counted as a prior line of treatment
- Measurable disease according to RECIST v 1.1.
Who cannot join
- Previous treatment with eribulin mesylate or any anti-PD-1, PD-L1, or PD-L2
- Active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment.
- Known central nervous system (CNS) disease, except for those subjects with treated brain metastasis who are stable for at least 1 month, having no evidence of progression or hemorrhage after treatment and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT]) during the screening period
- Known history of human immunodeficiency virus (HIV) positive
- Known active hepatitis B or hepatitis C (eg, HCV RNA detected)
- Any other malignancy that required treatment or has shown evidence of recurrence (except for nonmelanoma skin cancer, or histologically confirmed complete excision of carcinoma in situ) during the 3 years prior to enrollment in this study
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- History of significant cardiovascular disease
- Hypersensitivity to the active substance or any other excipients of the eribulin mesylate drug product, or to nivolumab
- Scheduled for major surgery during the study
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids may be allowed
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
- Has a history of interstitial lung disease
- Has received a live-virus vaccination within 30 days of planned start of study therapy. Seasonal flu vaccines that do not contain live virus are permitted.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam, 13620
About this study
Official title: A Phase IB/II, Single Arm, Multi-center Study of Nivolumab in Combination With Eribulin in HER2 Negative Metastatic Breast Cancer Patients
Cancer therapeutics such as chemotherapy may modulate tumor/immune-system interactions in favor of the immune system. Chemotherapy can result in tumor cell death with a resultant increase in tumor antigen delivery to antigen-presenting cells. Therefore, combining immunotherapy (Nivolumab) with chemotherapy (Eribulin) is a promising anti-cancer strategy.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Nivolumab
- Keywords
- breast cancer, eribulin, nivolumab, immunotherapy, immune checkpoint inhibitor, metastatic breast cancer, PD-1
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called Opdivo
Nivolumab 360mg on D1 every 3 weeks Eribulin 1.4mg/m2 on D1, 8 every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| ER+/HER2- breast cancer | Experimental | will be treated with a combination of eribulin and nivolumab Receives: Drug: Nivolumab |
| ER-/HER2- breast cancer | Experimental | will be treated with a combination of eribulin and nivolumab Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 months progression-free survival (PFS) rate
Measured: 6 months
Secondary outcomes (4)
Objective response rate by RECIST criteria v 1.1
Measured: 2 years
Overall survival (OS)
Measured: 2 years (upto 5 years)
Incidence Rate of each Toxicity by CTCAE 4.0
Measured: 2 years (upto 5 years)
Clinical benefit rate by RECIST criteria v 1.1 (and iRECIST)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start1 Aug 2019
- Primary completionApr 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- ER+/HER2- BC cohort: 45 pts ER-/HER2- (Triple negative) BC cohort: 45 pts
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Korean Cancer Study Group (KCSG), Eisai Korea Inc., Ono pharmaceutical Korea
- Responsible party
- Sponsor
- Investigators
- JEEHYUN KIM, MD,PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061863
- Sponsor's protocol ID
- KCSG BR18-16
- Acronym
- KORNELIA
- Status last verified
- Sep 2021
- First submitted
- 13 Aug 2019
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park C, Suh KJ, Kim SH, Lee KH, Im SA, Kim MH, Sohn J, Jeong JH, Jung KH, Lee KE, Park YH, Kim HJ, Cho EK, Choi IS, Noh SJ, Shin I, Cho DY, Kim JH. Genomic and transcriptomic profiles associated with response to eribulin and nivolumab combination in HER-2-negative metastatic breast cancer. Cancer Immunol Immunother. 2024 Aug 6;73(10):197. doi: 10.1007/s00262-024-03782-7.
PubMed 39105849Kim SH, Im SA, Suh KJ, Lee KH, Kim MH, Sohn J, Park YH, Kim JY, Jeong JH, Lee KE, Choi IS, Park KH, Kim HJ, Cho EK, Park SY, Kim M, Kim JH. Clinical activity of nivolumab in combination with eribulin in HER2-negative metastatic breast cancer: A phase IB/II study (KCSG BR18-16). Eur J Cancer. 2023 Dec;195:113386. doi: 10.1016/j.ejca.2023.113386. Epub 2023 Oct 14.
PubMed 37890351
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IB/II, Single Arm, Multi-center Study of Nivolumab in Combination With Eribulin in HER2 Negative Metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04061863
- Acronym / sponsor ID
- KORNELIA / KCSG BR18-16
- Conditions
- Metastatic Breast Cancer
- Keywords
- breast cancer, eribulin, nivolumab, immunotherapy, immune checkpoint inhibitor, metastatic breast cancer, PD-1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Korean Cancer Study Group (KCSG), Eisai Korea Inc., Ono pharmaceutical Korea
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 20 Aug 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.
Cancer therapeutics such as chemotherapy may modulate tumor/immune-system interactions in favor of the immune system. Chemotherapy can result in tumor cell death with a resultant increase in tumor antigen delivery to antigen-presenting cells. Therefore, combining immunotherapy (Nivolumab) with chemotherapy (Eribulin) is a promising anti-cancer strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- ER+/HER2- BC cohort: 45 pts ER-/HER2- (Triple negative) BC cohort: 45 pts
| Arm | Type | Receives |
|---|---|---|
| ER+/HER2- breast cancer | Experimental | Drug: Nivolumabwill be treated with a combination of eribulin and nivolumab |
| ER-/HER2- breast cancer | Experimental | Drug: Nivolumabwill be treated with a combination of eribulin and nivolumab |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provision of informed consent prior to any study specific procedures
- Age 20 years or older
- ECOG performance status(PS) 0 or 1
- Histologically confirmed stage IV or recurrent breast cancer
- HER2 negative disease: not eligible for anti-HER2 therapy
Key exclusion criteria (13 listed)
- Previous treatment with eribulin mesylate or any anti-PD-1, PD-L1, or PD-L2
- Active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment.
- Known central nervous system (CNS) disease, except for those subjects with treated brain metastasis who are stable for at least 1 month, having no evidence of progression or hemorrhage after treatment and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT]) during the screening period
- Known history of human immunodeficiency virus (HIV) positive
- Known active hepatitis B or hepatitis C (eg, HCV RNA detected)
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 |
|---|---|---|
| NivolumabAlso: OpdivoNivolumab 360mg on D1 every 3 weeks Eribulin 1.4mg/m2 on D1, 8 every 3 weeks | Drug | ER+/HER2- breast cancer, ER-/HER2- breast cancer |
Primary outcome
6 months progression-free survival (PFS) rate
Time frame: 6 months
4 secondary outcomes
Objective response rate by RECIST criteria v 1.1
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years (upto 5 years)
Incidence Rate of each Toxicity by CTCAE 4.0
Time frame: 2 years (upto 5 years)
Clinical benefit rate by RECIST criteria v 1.1 (and iRECIST)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Derived from this study: PubMed 39105849Park C, Suh KJ, Kim SH, Lee KH, Im SA, Kim MH, Sohn J, Jeong JH, Jung KH, Lee KE, Park YH, Kim HJ, Cho EK, Choi IS, Noh SJ, Shin I, Cho DY, Kim JH. Genomic and transcriptomic profiles associated with response to eribulin and nivolumab combination in HER-2-negative metastatic breast cancer. Cancer Immunol Immunother. 2024 Aug 6;73(10):197. doi: 10.1007/s00262-024-03782-7.
- Derived from this study: PubMed 37890351Kim SH, Im SA, Suh KJ, Lee KH, Kim MH, Sohn J, Park YH, Kim JY, Jeong JH, Lee KE, Choi IS, Park KH, Kim HJ, Cho EK, Park SY, Kim M, Kim JH. Clinical activity of nivolumab in combination with eribulin in HER2-negative metastatic breast cancer: A phase IB/II study (KCSG BR18-16). Eur J Cancer. 2023 Dec;195:113386. doi: 10.1016/j.ejca.2023.113386. Epub 2023 Oct 14.
- Korea Cancer Study GroupLink provided by the sponsor.
- Seoul National University Bundang HospitalLink provided by the sponsor.
- 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.
JEEHYUN KIM, MD,PhD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nivolumab in people with Metastatic Breast Cancer, run by Seoul National University Hospital 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 9 inclusion and 13 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 8 Sep 2021. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 months progression-free survival (PFS) rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04061863, which also lists 2 linked publications.
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 8 Sep 2021.