NCT04061863

Brief 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. Therefore, combining immunotherapy (Nivolumab) with chemotherapy (Eribulin) is a promising anti-cancer strategy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2019

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 20, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 8, 2021

Status Verified

September 1, 2021

Enrollment Period

2.7 years

First QC Date

August 13, 2019

Last Update Submit

September 5, 2021

Conditions

Metastatic Breast Cancer

Keywords

breast cancereribulinnivolumabimmunotherapyimmune checkpoint inhibitormetastatic breast cancerPD-1

Outcome Measures

Primary Outcomes (1)

  • 6 months progression-free survival (PFS) rate

    6 months

Secondary Outcomes (4)

  • Objective response rate by RECIST criteria v 1.1

    2 years

  • Overall survival (OS)

    2 years (upto 5 years)

  • Incidence Rate of each Toxicity by CTCAE 4.0

    2 years (upto 5 years)

  • Clinical benefit rate by RECIST criteria v 1.1 (and iRECIST)

    2 years

Study Arms (2)

ER+/HER2- breast cancer

EXPERIMENTAL

will be treated with a combination of eribulin and nivolumab

Drug: Nivolumab

ER-/HER2- breast cancer

EXPERIMENTAL

will be treated with a combination of eribulin and nivolumab

Drug: Nivolumab

Interventions

NivolumabDRUG

Nivolumab 360mg on D1 every 3 weeks Eribulin 1.4mg/m2 on D1, 8 every 3 weeks

Also known as: Opdivo
ER+/HER2- breast cancerER-/HER2- breast cancer

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 39105849DERIVED

  • Kim 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.

    PMID: 37890351DERIVED

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • JEEHYUN KIM, MD,PhD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: ER+/HER2- BC cohort: 45 pts ER-/HER2- (Triple negative) BC cohort: 45 pts
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2019

First Posted

August 20, 2019

Study Start

August 1, 2019

Primary Completion

April 1, 2022

Study Completion

December 1, 2022

Last Updated

September 8, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)