EUCTR2017-000220-10-BE进行中（未招募）1 期
A randomized phase IIb study evaluating immunogenic chemotherapy combined with ipilimumab and nivolumab in patients with metastatic hormone receptor positive breast cancer - ICON CA209-9F
Oslo University Hospital0 个研究点目标入组 75 人开始时间: 2019年3月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Metastatic hormone receptor positive breast cancer (primary or recurrent), defined as ER+ >1% in metastatic biopsy (archival material or study biopsy) or cytology and HER2 negative in the last biopsy or cytology evaluable for HER2. HER2-analysis is to be perfomed according to national criteria.
- •2.Adequate core or excisional study biopsy of a tumor lesion. Lesions in previously irradiated areas may only be used for the biopsy if the lesion has appeared or progressed after radiation. . No anti-tumor treatment is allowed between the time point for biopsy and study entry.
- •3.Measurable metastatic disease according to RECIST
- •4.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •5.Signed Informed Consent Form
- •6.Women or men aged = 18 years
- •7.A minimum of 12 months from adjuvant/neoadjuvant chemotherapy with antracyclins to relapse of disease.
- •8.A maximum of one previous line with chemotherapy in the metastatic setting
- •9.Chemotherapy is considered as preferred treatment
- •10.Previous endocrine and targeted therapy is allowed
- •11.No use of systemic corticosteroids at study entry
- •12.Female subject of childbearing potential should have a negative urine or serum pregnancy within 7 days prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- •13.Female subjects of childbearing potential should agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year, during the treatment period and for at least 5 months after the last dose of study therapy.
- •14.Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 7 months after the last dose of study therapy
- •15.Able to swallow and retain orally administered medication
- •16.Adequate organ function as defined in Table 1
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Malignancies other than breast cancer within 5 years prior to randomization
- •2.Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to randomization
- •3.Known CNS disease, except for asymptomatic CNS metastases, provided all of the following criteria in the protocol are met.
- •4.Uncontrolled pleural effusion, pericardial effusion, or ascites. Patients with indwelling catheters are allowed
- •5.Uncontrolled tumor-related pain. Patients requiring narcotic pain medication must be on a stable regimen at study entry. Symptomatic lesions amenable to palliative radiotherapy should be treated prior to randomization. Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain should be considered for loco-regional therapy if appropriate prior to randomization
- •6.Ionized calcium > 1.2 x UNL.
- •7.Pregnant or breastfeeding
- •8.Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease
- •9.Significant cardiovascular disease. Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or LVEF < 50% must be on a stable medical regimen that is optimized
- •10.Severe infection within 21 days prior to randomization, requiring hospitalization
- •11.Received oral or IV antibiotics within 1 week prior to Cycle 1, Day 1.
- •12.Major surgical procedure within 21 days prior to randomization or anticipation of the?need for a major surgical procedure during the course of the study other than for diagnosis.
- •13.A history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •14.Known hypersensitivity to any of the components of the investigational products
- •15.A history of autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic treatment.? Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations only are permitted provided that they meet all of the following conditions defined in the protocol.
- •16.Undergone allogeneic stem cell or solid organ transplantation
- •17.A history of idiopathic pulmonary fibrosis or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- •18.A positive test for HIV
- •19.Active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C.
- •20.Active tuberculosis
- •21.Currently receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment
- •22.Received treatment with immune checkpoint modulators
- •23.Received treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug (whichever is shorter) prior to randomization
- •24.Received treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to randomization, or anticipated requirement for systemic immunosuppressive medications during the trial
- •a.Patients wh
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