A Phase II Clinical Trial of MK-3475 (Pembrolizumab) in Subjects With Relapsed or Refractory (R/R) Classical Hodgkin Lymphoma (cHL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 211
- 主要终点
- Overall Response Rate (ORR) by BICR Based on IWG Criteria
研究概览
简要总结
This is a study of pembrolizumab (MK-3475) for participants with relapsed/refractory classical Hodgkin Lymphoma (RRcHL) who: 1) have failed to achieve a response or progressed after autologous stem cell transplant (auto-SCT) and have relapsed after treatment with or failed to respond to brentuximab vedotin (BV) post auto-SCT or 2) were unable to achieve a Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV or 3) have failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT.
The primary study hypothesis is that treatment with single agent pembrolizumab will result in a clinically meaningful overall response rate.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1
Participants with RRcHL who failed to achieve a response or progressed after auto-SCT and have relapsed after treatment with or failed to respond to BV post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle for up to 24 months.
干预措施: pembrolizumab (Biological)
Cohort 2
Participants with RRcHL who were unable to achieve CR or PR to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle for up to 24 months.
干预措施: pembrolizumab (Biological)
Cohort 3
Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.
干预措施: pembrolizumab (Biological)
结局指标
主要结局
Overall Response Rate (ORR) by BICR Based on IWG Criteria
时间窗: Up to approximately 99 months
ORR is the percentage of participants who had a complete response (CR) or partial response (PR) prior to disease progression based on the International Working Group (IWG) criteria using blinded independent central review (BICR). CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. The point estimate and 95% 2-sided exact confidence interval (CI) used the Clopper-Pearson method. An exact binomial test was conducted for each cohort versus a fixed control rate for each cohort. It is hypothesized that ORR will be greater than 20% in each of the 3 cohorts.
Percentage of Participants Experiencing at Least One Adverse Event (AE)
时间窗: Up to 27 months
An adverse event (AE) is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study
Percentage of Participants Discontinuing Study Drug Due to AEs
时间窗: Up to 24 months
An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study
次要结局
- Overall Response Rate (ORR) by BICR Based on Lugano Criteria(Up to approximately 99 months)
- Progression-free Survival (PFS) Based on BICR(Up to approximately 99 months)
- Progression-free Survival (PFS) Assessed by the Investigator(Up to approximately 99 months)
- Duration of Response (DOR) Based on BICR(Up to approximately 99 months)
- Duration of Response (DOR) Assessed by the Investigator(Up to approximately 99 months)
- Overall Survival (OS)(Up to approximately 99 months)
- Overall Response Rate (ORR) Assessed by Investigator Based on IWG Criteria(Up to approximately 99 months)
- Complete Remission Rate (CRR) by BICR Based on Lugano Criteria(Up to approximately 99 months)
- Complete Remission Rate (CRR) by BICR Based on IWG Criteria(Up to approximately 99 months)
- Complete Remission Rate (CRR) Assessed by Investigator Based on IWG Criteria(Up to approximately 99 months)