Phase Ib Study of MK-3475 in Subjects With Advanced Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Number of Participants Discontinuing Treatment Due to AEs
研究概览
简要总结
This study will assess the safety, tolerability, and efficacy of every-3-week dosing (Q3W) of pembrolizumab (MK-3475) in participants with advanced melanoma; participants may receive pembrolizumab for up to 2 years if deriving clinical benefit. The primary study hypothesis is that treatment with single agent pembrolizumab will result in a clinically meaningful overall response rate.
详细描述
Participants who discontinue pembrolizumab after achieving a complete response (CR) and subsequently develop progressive disease (PD) may be eligible to enter a Second Course Phase and receive pembrolizumab again.
The end of the study for each participant will occur with: 1) the marketing approval of pembrolizumab for melanoma, 2) the completion of safety follow up or 3) the time when a possibility of entry to second course of treatment is lost, whichever occurs last.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 confirmed diagnosis of locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma not amenable to local therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •At least one measurable lesion
- •Adequate organ function
排除标准
- •Prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-PD ligand-1 (PD-L1), anti-PD-L2, anti-CD137 antibody, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) agent
- •Is currently participating or has participated in a study with an investigational compound or device within 30 days, or 5X half-life of the investigational compound, whichever is longer, of initial dosing on this study
- •Chemotherapy, targeted small molecule therapy, radiotherapy, or biological cancer therapy (including monoclonal antibodies) within 4 weeks prior to the first dose of trial treatment, or not recovered (<= Grade 1 or baseline) from adverse events due to a previously administered agent
- •Expected to require any other form of systemic or localized antineoplastic therapy while in study
- •Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- •Documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
- •Receiving systemic steroid therapy or any other form of immunosuppressive therapy within 1 week prior to the first dose of study treatment
- •Received a live vaccine within 4 weeks prior to the first dose of trial treatment
- •Has a known hypersensitivity to the components of the study drug or another monoclonal antibody
- •History or evidence of active pneumonitis
- •Human immunodeficiency virus (HIV)-positive
- •Has known history of active Hepatitis B or C
- •Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial treatment through 120 days after the last dose of study medication
研究组 & 干预措施
Advanced Mucosal Melanoma
Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
干预措施: Pembrolizumab (Biological)
Advanced Cutaneous Melanoma
Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, intravenously (IV) over 30 minutes on Day 1 of each 3-week dosing cycle (Q3W).
干预措施: Pembrolizumab (Biological)
结局指标
主要结局
Number of Participants Discontinuing Treatment Due to AEs
时间窗: Up to last dose of study drug (Up to 24 months)
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Number of Participants Experiencing Adverse Events (AEs)
时间窗: All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Overall Response Rate (ORR) Per Central Radiology Review Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
时间窗: Up to 24 months
The ORR, using RECIST 1.1, was defined as the percentage of participants in the analysis population who had a confirmed 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) at any time during the study, based on central radiology review.
次要结局
- ORR Per Central Radiology Review Using Immune-related Response Criteria (irRC)(Up to 24 months)
- ORR Per Investigator Assessment Using RECIST 1.1(Up to 24 months)