NL-OMON52889已完成2 期
Monalizumab and trastuzumab In Metastatic HER2-pOStive breAst cancer: MIMOSA-trial - MIMOSA
ederlands Kanker Instituut0 个研究点目标入组 19 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Histologically confirmed HER2-positive (immunohistochemistry 2+ with SISH
- •amplification or 3+ reagrdless of SISH amplification) breast cancer.
- •HER2-positivity must have been assessed on a baseline study biopsy of a
- •metastatic lesion.
- •Histological or cytological confirmed locally incurable or metastatic disease
- •Accessible lesion for study biopsies.
- •Administration of at least one line of palliative treatment with documented
- •progression and a maximum of three lines of palliative chemotherapy in
- •combination with HER2 targeting agents (TDM-1 is considered one line of
- •palliative treatment). Trastuzumab in combination with endocrine treatment is
- •not defined as one line of treatment.
- •Documented progression during previous trastuzumab-based therapy
- •Measurable disease according to RECIST1.1 (at least one target lesion)
- •Left ventricular ejection fraction of 50% or higher
- •WHO performance status of 0 or 1
- •No signs of a visceral crisis
- •Signed written informed consent
- •- Subjects with brain metastases are eligible if they have been treated,
- •asymptomatic and there is no magnetic resonance imaging (MRI) evidence of
- •progression for at least 4 weeks prior to study registration. There must also
- •be no requirement for immunosuppressive doses of systemic corticosteroids (> 10
- •mg/day prednisone equivalents) for at least 2 weeks prior to study drug
- •administration
排除标准
- •uncontrolled intercurrent illness including, but not limited to, ongoing or
- •active infection, symptomatic congestive heart failure, unstable angina pectoris
- •known leptomeningeal disease localization
- •history of having received other anticancer therapies within 2 weeks of start
- •of the study drug
- •history of immunodeficiency, autoimmune disease, conditions requiring
- •immunosuppression (>10 mg daily prednisone equivalents) or chronic infections.
- •Subjects with vitiligo, diabetes mellitus type I on a stable insulin regimen,
- •psoriasis not requiring systemic treatment or resolved childhood asthma/atopy
- •would be an exception to this rule. Subjects that require intermittent use of
- •bronchodilators, inhaled steroids, or local steroid injections will not be
- •excluded from the study. Subjects with hypothyroidism stable on hormone
- •replacement, Sjøgren*s syndrome or conditions not expected to recur in the
- •absence of an external trigger will not be excluded from the study. In
- •addition, subjects with Graves* disease stable on hormone replacement will also
- •not be excluded from the study. Adrenal replacement doses >10 mg daily
- •prednisone equivalents are permitted in the absence of active autoimmune disease
- •prior treatment with immune checkpoint blockade or other forms of
- •immunotherapy, such as but not limited to: anti-PD-(L)1, anti-PD-L2,
- •anti-CTLA-4, anti-GITR or CD137/OX40 agonists
- •prior treatment with HER2-based vaccines
- •live vaccine within two weeks prior to start of the study, at any time during
- •the study or within 5 months following the last dose of monalizumab.
- •Inactivated vaccines, such as the seasonal flu vaccination, are allowed
- •history of clinically significant or uncontrolled cardiac disease, including
- •congestive heart failure (New York Heart Association functional classification
- •>=3), angina, myocardial infarction within 12 months prior to study treatment or
- •ventricular arrhythmia.
- •active other cancer
- •positive test for hepatitis B surface virus surface antigen (HBsAg) or
- •hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic
- •allogeneic stem cell or organ transplantation, HIV or active tuberculosis
- •history of uncontrolled serious medical or psychiatric illness
- •Presence of any psychological, familial, sociological or geographical
- •condition potentially hampering compliance with the study protocol and
- •follow-up schedule
- •current pregnancy or breastfeeding. Women of childbearing potential (WOCBP*)
- •must use adequate contraceptive protection. WOCBP must have a negative serum or
- •urine pregnancy test
研究者
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