EUCTR2017-004865-28-IT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 -
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
- •1. Patient is an adult = 18 years old at the time of informed consent, and has signed informed consent before any trial related activities and according to local guidelines
- •2. Patient has advanced (loco-regionally recurrent not amenable to curative therapy or metastatic) breast cancer.
- •3. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •4. Patient has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by central laboratory for eligibility):
- •- Absolute neutrophil count = 1.5× 109/L
- •- Platelets = 100 × 109/L
- •- Hemoglobin = 9.0 g/dL
- •- Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) = 40 mL/min
- •- Alanine aminotransferase (ALT) < 3 x ULN, except for patients that have tumor involvement of the liver, who may only be included if ALT =5.0 x ULN who are
- •excluded if ALT > 5 x ULN
- •- Aspartate aminotransferase (AST) < 3 x ULN, except for patients that have tumor involvement of the liver, who may only be included if AST =5.0 x ULN who are excluded if AST > 5 x ULN
- •- Total serum bilirubin < 1.5 ULN; or total bilirubin = 3.0 × ULN with direct bilirubin within normal range of the central laboratory in patients with well documented Gilbert’s Syndrome
- •5. 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).
- •6. Patient progressed after adjuvant or 1 prior systemic treatment in the advanced setting.
- •Patients with de novo metastatic disease are eligible if they received 1 prior line of therapy.
- •7. Patient must have received prior systemic treatment that included taxane-based chemotherapy for adjuvant or metastatic disease.
- •8. 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.
- •9. Patient has histologically and/or cytologically confirmed diagnosis of advanced TNBC (based on most recently analyzed biopsy from locally recurrent or metastatic site, 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) Hammond et al 2010.
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 59
排除标准
- •1. Patient has received prior immune checkpoint inhibitors as anticancer treatment, such as anti-LAG-3, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibody (any line of therapy).
- •2. Patient received prior neoadjuvant or adjuvant therapy with a platinum agent or mitomycin and experienced recurrence within 12 months after the end of the platinumbased or mitomycin containing therapy, or received platinum or mitomycin for advanced disease.
- •3. Patient is concurrently using other anti-cancer therapy.
- •4. 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.
- •5. Patient with presence of CTCAE grade 2 toxicity or higher due to prior cancer therapy.
- •Exception: Patients with any grade of alopecia are allowed to enter the study.
- •6. 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).
- •7. Patient has a known hypersensitivity to other monoclonal antibodies, platinum-containing compounds, or to any of the excipients of LAG525, spartalizumab, or carboplatin.
- •8. Patient with history of Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis, or a history of severe hypersensitivity reactions, which in the opinion of the investigator may pose an increased risk of serious infusion reaction.
- •9. History of acute pancreatitis within 1 year of screening or past medical history of chronic
- •pancreatitis.
- •10. Clinically significant cardiac disease or impaired cardiac function, including any of the following: Cardiac or cardiac repolarization abnormality, including any of the following:
- •i. History of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG) within 6 months prior to randomization
- •ii. History or current diagnosis of myocarditis
- •iii. Cardiac troponin T (TnT) or I (TnI) elevated > 2 x ULN at screening. Repeat Troponin test if values are between >1 and 2 x ULN:
- •- Patients with a screening or repeat levels = 1 x ULN may be included.
- •- If repeat Troponin levels are > 1 and < 2 x ULN, patient can be included at the investigator’s discretion after cardiac assessment
- •- Repeat assessment should be performed the following day if possible but may be later.
- •iv. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block) or uncontrolled hypertension
- •v. QTcF > 470 msec on screening central ECG or long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
- •- Risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically
- •significant/symptomatic bradycardia
- •- Concomitant medication(s) known to cause Torsades de Pointe” per www.qtdrugs.org that cannot be discontinued or replaced by safe alternative medication. (within 5 half-lives or 7 days prior to starting study drug)
- •- Inability to determine the QTcF interval.
- •Other protocol-defined exclusion criteria may apply.
研究者
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