An Open-label, Non-randomized, Multi-center Phase Ib Study of MK-3475 in Subjects With PD-L1 Positive Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 主要终点
- Number of Participants Experiencing Adverse Events (AEs)
研究概览
简要总结
This study is being done to evaluate the safety and efficacy of pembrolizumab (MK-3475) in participants with advanced non-small cell lung cancer (NSCLC) tumors that are positive for programmed cell death ligand 1 (PD-L1): the hypothesis is that treatment with pembrolizumab will result in a clinically meaningful Overall Response Rate (ORR).
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) that is PD-L1 positive per central laboratory review
- •At least one measurable lesion
- •Radiographic progression of NSCLC after treatment with a platinum-containing doublet for Stage IIIB/IV or recurrent disease
- •Eastern Cooperative Oncology Group (ECOG) Performance Scale 0 or 1
- •Adequate organ function
排除标准
- •Systemic cytotoxic chemotherapy, biological therapy, or major surgery within 3 weeks of the first dose of trial treatment
- •Systemic steroid therapy within 3 days prior to the first dose of trial treatment or any other form of immunosuppressive medication
- •Expected to require any other form of systemic or localized antineoplastic therapy while on trial
- •History of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cancer
- •Active central nervous system (CNS) metastases and/or carcinomatous meningitis
- •Active autoimmune disease or documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
- •Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody
- •Concurrent or past history of interstitial lung disease
- •Pregnant or breast-feeding, or expecting to conceive or father children within the projected duration of the study, starting with screening visit through 120 days after the last dose of pembrolizumab
研究组 & 干预措施
Pembrolizumab 10 mg/kg
Participants receive pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
干预措施: Pembrolizumab (Biological)
结局指标
主要结局
Number of Participants Experiencing Adverse Events (AEs)
时间窗: Up to 27 months (Up to 90 days after last dose of study drug)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. After discontinuation of study drug, each participant was monitored for a minimum of 30 days for AE monitoring (serious AEs were monitored for up to 90 days after last dose of study drug). The number of participants who experienced an AE is presented.
Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Strongly PD-L1 Positive Participants
时间窗: Up to 2 years
On-study imaging was to be performed every 9 weeks after the first dose of study drug, or more frequently if clinically indicated. ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). The percentage of strongly PD-L1 positive participants who experienced a CR or PR is presented.
Number of Participants Discontinuing Study Drug Due to AEs
时间窗: Up to 2 years
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. The number of participants who discontinued study drug due to an AE is presented.
次要结局
- Duration of Response (DOR) by RECIST 1.1 in Strongly PD-L1 Positive Participants(Up to 2 years)
- Progression Free Survival (PFS) by RECIST 1.1 in Strongly PD-L1 Positive Participants(Up to 2 years)
- Overall Survival (OS) in Strongly PD-L1 Positive Participants(Up to 2 years)
- ORR Per Immune-Related Response Criteria (irRC) in Strongly PD-L1 Positive Participants(Up to 2 years)
- PFS Per irRC in Strongly PD-L1 Positive Participants(Up to 2 years)
- DOR Per irRC in Strongly PD-L1 Positive Participants(Up to 2 years)
- ORR Per RECIST 1.1 in PD-L1 Positive Participants(Up to 2 years)
- PFS by RECIST 1.1 in PD-L1 Positive Participants(Up to 2 years)
- DOR by RECIST 1.1 in PD-L1 Positive Participants(Up to 2 years)
- ORR Per irRC in PD-L1 Positive Participants(Up to 2 years)
- DOR Per irRC in PD-L1 Positive Participants(Up to 2 years)
- OS in PD-L1 Positive Participants(Up to 2 years)
- PFS Per irRC in PD-L1 Positive Participants(Up to 2 years)