Pilot Study of Carboplatin, Nab-Paclitaxel and Pembrolizumab for Metastatic Triple-Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Overall Response Rate (ORR) in Patients Treated With CNP
研究概览
简要总结
The purpose of this study is to see how effective the combination of the two chemotherapy drugs (carboplatin and nab-paclitaxel) are when added to a third drug, pembrolizumab.
Pembrolizumab is an investigational (experimental) drug that works by reinvigorating the immune system, allowing it to target and destroy cancer cells. Pembrolizumab is experimental because it is not approved by the Food and Drug Administration (FDA) for this type of breast cancer treatment.
详细描述
Primary Objective - Determine overall response rate (ORR) in patients treated with CNP
Secondary Objective(s)
- Determine progression-free survival (PFS), and disease control rate (DCR) in patients treated with CNP.
- Determine duration of response in patients treated with CNP.
- Determine safety/tolerability of CNP.
Correlative Endpoints
- Identify pathologic and genomic correlates of response to CNP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have histologically or cytologically confirmed metastatic triple negative breast cancer
- •Subjects must have received no more than 2 prior therapies for this disease
- •ECOG Performance Status 0-1
- •Subjects must have normal organ and marrow function as defined below:
- •Hemoglobin ≥ 10.0 g/dl
- •Absolute neutrophil count ≥ 1,000/μL
- •Platelet count ≥ 100,000/μL
- •Total bilirubin within normal institutional limits
- •AST (SGOT) ≤ 2.5 X institutional upper limit of normal
- •ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
- •Serum creatinine ≤ 1.5 normal institutional limits
- •Life expectancy of 12 weeks or more
- •Subjects must have the ability to understand and the willingness to sign a written informed consent document
- •Subjects must have measurable disease per RECIST v1.1
- •Subjects must be willing to undergo a preliminary biopsy of a metastatic focus for research purposes. A second post-treatment biopsy will be offered but will not be mandated
排除标准
- •Prior treatment toxicities have not resolved to ≤ Grade 1 according to NCI CTCAE Version 4.0 (except for alopecia and neuropathy)
- •Subjects receiving any other investigational agents
- •Subjects with radiographically stable treated brain metastases are eligible but must not have been on steroid therapy for at least 4 weeks
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to nab-paclitaxel, carboplatin, pembrolizumab, or other agents used in this study
- •Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Pregnant or breastfeeding women are excluded from this study
- •Patients with conditions requiring immunosuppressive medications or chronic infections (including HIV infection, hepatitis B and C)
- •Patients with chronic autoimmune disease
- •Patients with prior therapy with antibodies that modulate T-cell function (e.g., anti-PD-1, anti-PD-L1)
- •Patients with evidence of active, non-infectious pneumonia
- •Patients active infection requiring intravenous systemic therapy
- •Patients with known psychiatric or substance abuse disorders that would interfere with cooperation with requirements of the trial
- •Patients who have received a live vaccine within 30 days prior to the first dose of pembrolizumab
- •Patients with a known additional malignancy that is progressing or requires active treatment (within the last 5 years). Exceptions: basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ cervical cancer that has undergone potentially curative therapy
- •Patients who have received monoclonal anti-cancer antibody within 4 weeks of first dose of study drugs
- •Patients who have received chemotherapy, small molecule targeted therapy or radiation within the 2 weeks of first dose of study drugs
- •Patients who have participated in MK-3475 Merck studies
- •Patients with carcinomatous meningitis
研究组 & 干预措施
Carboplatin + Nab-paclitaxel + Pembrolizumab
Combination therapy of Carboplatin, Nab-paclitaxel, and Pembrolizumab
干预措施: Carboplatin (Drug)
Carboplatin + Nab-paclitaxel + Pembrolizumab
Combination therapy of Carboplatin, Nab-paclitaxel, and Pembrolizumab
干预措施: Nab-paclitaxel (Drug)
Carboplatin + Nab-paclitaxel + Pembrolizumab
Combination therapy of Carboplatin, Nab-paclitaxel, and Pembrolizumab
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Overall Response Rate (ORR) in Patients Treated With CNP
时间窗: Up to 24 months
The number of people with tumor responses according to RECIST (V1.1). These responses include Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study
次要结局
- Progression-free Survival (PFS) in Patients Treated With CNP(Up to 24 months)
- Disease Control Rate (DCR) in Patients Treated With CNP(Up to 24 months)
- Duration of Response in Patients Treated With CNP(Up to 24 months)
研究者
Joseph Baar, MD, PhD
Associate Professor of Medicine
Case Comprehensive Cancer Center