EUCTR2017-004865-28-ES进行中（未招募）1 期
A phase II open-label, randomized, three-arm, multicenter study of LAG525 given in combination with spartalizumab (PDR001), or with spartalizumab and carboplatin, or with carboplatin, as first or second line therapy in patients with advanced triple-negative breast cancer
ovartis Farmacéutica, S.A0 个研究点目标入组 88 人开始时间: 2018年9月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 88
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
- •Patient has advanced (loco-regionally recurrent not amenable to curative therapy or metastatic) breast cancer.
- •Patient must have measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria (Tumor lesions previously irradiated or subjected to other loco-regional therapy will only be considered measurable if disease progression at the treated site after completion of therapy is clearly documented)
- •Patient progressed after adjuvant or 1 prior systemic treatment in the metastatic setting. Patients with de novo metastatic disease are eligible if they received 1 prior line of therapy
- •Patient must have received prior systemic treatment that included taxane-based chemotherapy for adjuvant or metastatic disease
- •Patient must have a site of disease amenable to biopsy, and must be willing to undergo a new tumor biopsy at screening and during therapy on this study, the latter if medically feasible. Patients with an available archival tumor tissue do not need to perform a tumor biopsy at screening if patient has not received anti-cancer therapy since the biopsy was taken.
- •Patient has histologically and/or cytologically confirmed diagnosis of TNBC (based on most recently analyzed biopsy, local lab) meeting the following criteria: HER2 negative in situ hybridization test or an IHC status of 0 or 1+, and ER and PR expression is <1 percent as determined by immunohistochemistry (IHC)
- •Other protocol-defined inclusion criteria may apply
- •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 29
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 67
排除标准
- •Patient has received prior treatment with anti-LAG-3, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibody (any line of therapy).
- •Patient received prior therapy with a platinum agent or mitomycin and experienced recurrence within 12 months after the end of the platinum-based or mitomycin containing therapy
- •Patient has had major surgery within 14 days prior to starting study treatment or has not recovered to grade 1 or less from major side effects.
- •Patient with presence of CTCAE = grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are
- •excluded if = CTCAE grade 3) due to prior cancer therapy.
- •Patient has received radiotherapy = 4 weeks prior to randomization (= 2 weeks for limited field radiation for palliation), and has not recovered to grade 1 or better from related side effects of such therapy (with the exception of alopecia).
- •Patient has a known hypersensitivity to other monoclonal antibodies, platinumcontaining compounds, or to any of the excipients of LAG525, spartalizumab, or carboplatin.
- •Patient with history or presence of central nervous system (CNS) metastases, treated or untreated.
- •Other protocol-defined exclusion criteria may apply
研究者
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