NCT02435680已完成2 期
A Randomized Phase II Study of MCS110 Combined With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Progression Free Survival (PFS) as Per RECIST v1.1 (by Local Investigator Assessment)
研究概览
简要总结
To determine whether MCS110 antibody therapy improves the efficacy of carboplatin and gemcitabine (carbo/gem) in advanced TNBC patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women (≥ 18 years of age) with advanced TNBC.
- •Histological or cytological evidence of estrogen-receptor negative (ER-), progesterone receptor negative (PgR-) and human epidermal growth factor-2 receptor negative (HER2-) Breast Cancer by local laboratory testing, based on last available tumor tissue.
- •ER/PgR negativity to follow local guidelines
- •If IHC HER2 2+, a negative FISH test is required
- •A pre-treatment tumor biopsy demonstrating high TAM content as assessed per the central laboratory
- •Patients must have:
- •At least one measurable lesion per RECIST 1.
- •(Note: Measurable lesions include lytic or mixed (lytic + blastic) bone lesions, with an identifiable soft tissue component that meets the measurability criteria)
排除标准
- •Prior chemotherapy for advanced BC. Previous adjuvant/neoadjuvant chemotherapy is allowed (carboplatin, cisplatin or gemcitabine only if > 12 months has passed since last administration).
- •Therapy for underlying malignancy within 2 weeks prior to start of study treatment:
- •Chemotherapy, biologic therapy (antibodies and biologically targeted small molecules)
- •Radiotherapy
- •Major surgery
- •Patients receiving concomitant immunosuppressive agents or chronic corticosteroids (≥10 mg of prednisone or equivalent) at the time of first study dose.
- •Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening.
- •Known history of human immunodeficiency virus or active infection with hepatitis virus or any uncontrolled active systemic infection.
- •Patients with the following laboratory values during screening and on Day 1 predose:
- •Absolute Neutrophil Count (ANC) < 1.5x109/L
- •Hemoglobin < 9 g/dL
- •Platelets < 100x109/L
- •Serum creatinine > 1.5 x ULN
- •Serum total bilirubin > 1.5 x ULN
- •AST/SGOT and ALT/SGPT > 3.0 x ULN
研究组 & 干预措施
Arm 1: MCS110+carboplatin+gemcitabine
Experimental
MCS110+carboplatin+gemcitabine
干预措施: MCS110 (Drug)
Arm 1: MCS110+carboplatin+gemcitabine
Experimental
MCS110+carboplatin+gemcitabine
干预措施: carboplatin (Drug)
Arm 1: MCS110+carboplatin+gemcitabine
Experimental
MCS110+carboplatin+gemcitabine
干预措施: gemcitabine (Drug)
Arm 2: carboplatin+gemcitabine
Active Comparator
carboplatin+gemcitabine
干预措施: carboplatin (Drug)
Arm 2: carboplatin+gemcitabine
Active Comparator
carboplatin+gemcitabine
干预措施: gemcitabine (Drug)
结局指标
主要结局
Progression Free Survival (PFS) as Per RECIST v1.1 (by Local Investigator Assessment)
时间窗: 4 years
PFS Results presented for all MCS110 treated patients (with and without day 8 dose), in line with phase 2 study design.
次要结局
- Free MCS110 : Derived Pharmacokinetics (PK) Parameters: AUCtau(day 21 (end cycle 1); day 84 (end cycle 4))
- Free MCS110 : Derived Pharmacokinetics (PK) Parameters: Cmax(day 21 (end cycle 1); day 84 (end cycle 4))
- MCS110 Dose Intensity(4 years)
- Tumor Associated Macrophage (TAM) and Tumor Infiltrating Lymphocyte (TIL) Content in Pre- and Post-dose Tumor Biopsies.(Baseline, Day 29-43)
- Cmax Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)(day 21, day 84)
- Circulating Monocytes Cells in Blood(day 15, 29, 43, 50)
- AUClast Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)(day 21, day 84)
- Total Colony Stimulation Factor -1 (CSF-I) Circulating Levels(baseline, day 1, 4, 15, 22, 43, 64, 85, 106, 127, 148)
- Serum C-terminal Telopeptide of Type I Collagen (CTX-I)(baseline, day 2, 4, 15, 22, 43, 64, 85, 106, 127, 148)
- Tumor Response Per RECIST v1.1 (by Local Investigator Assessment)(4 years)
- Tumor Response Per RECIST v1.1 (by Local Investigator Assessment) Duration of Response(4 years)
- Number of Patients With at Least One MCS110 Dose Reduction, and Number of Patients With at Least One MCS110 Dose Interruption(4 years)
研究者
研究点 (3)
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