A Phase III, Randomized, Open-label, Clinical Trial to Compare Pembrolizumab With Brentuximab Vedotin in Subjects With Relapsed or Refractory Classical Hodgkin Lymphoma

Merck Sharp & Dohme LLC0 个研究点目标入组 304 人2016年5月23日

适应症Hodgkin Lymphoma

干预措施pembrolizumab brentuximab vedotin

相关药物pembrolizumab brentuximab vedotin

概览

阶段: 3 期
干预措施: pembrolizumab
疾病 / 适应症: Hodgkin Lymphoma
发起方: Merck Sharp & Dohme LLC
入组人数: 304
主要终点: Progression-free Survival (PFS)
状态: 已完成
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标相似试验

概览

简要总结

The purpose of this study is to evaluate pembrolizumab (MK-3475) in the treatment of participants with relapsed or refractory Classical Hodgkin Lymphoma. Participants will be randomized to receive either pembrolizumab or brentuximab vedotin (BV) for up to 35 three-week cycles of treatment.

The primary hypotheses of this study are that treatment with pembrolizumab prolongs Progression-free Survival (PFS) and Overall Survival (OS) in participants with relapsed or refractory Classical Hodgkin Lymphoma compared to treatment with BV.

注册库

clinicaltrials.gov

开始日期

2016年5月23日

结束日期

2026年1月14日

最后更新

2个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Merck Sharp & Dohme LLC

责任方

Sponsor

入排标准

入选标准

•Has relapsed (disease progression after most recent therapy) or refractory (failure to achieve Complete Response \[CR\] or Partial Response \[PR\] to most recent therapy) classical Hodgkin Lymphoma.
•Has responded (achieved a CR or PR) to BV or BV-containing regimens, if previously treated with BV.
•Has measurable disease defined as ≥1 lesion that can be accurately measured in ≥2 dimensions with spiral computed tomography (CT) scan or combined CT/positron emission tomography (PET) scan. Minimum measurement must be \>15 mm in the longest diameter or \>10 mm in the short axis.
•Is able to provide an evaluable core or excisional lymph node biopsy for biomarker analysis from an archival (\>60 days) or newly obtained (within 60 days) biopsy at Screening (Visit 1).
•Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
•Has adequate organ function
•Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days (for participants receiving pembrolizumab) or 180 days (for participants receiving BV) after the last dose of study drug.
•Male participants of childbearing potential must be willing to use an adequate method of contraception starting with the first dose of study drug through 120 days (for participants receiving pembrolizumab) or 180 days (for participants receiving BV) after the last dose of study drug.

排除标准

•Has hypersensitivity to the active substance or to any of the excipients in BV or pembrolizumab.
•Is currently participating in or has participated in a study of an investigational agent and is currently receiving study therapy or has participated in a study of an investigational agent and has received study therapy or used an investigational device within 4 weeks of the first dose of study drug.
•Has a diagnosis of immunosuppression or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
•Has had a prior monoclonal antibody (mAb) within 4 weeks prior to first dose of study drug in the study or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events (AEs) due to agents administered more than 4 weeks earlier.
•Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy including investigational agents within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from AEs due to a previously administered agent.
•Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years. Note: Participants who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of graft-versus-host disease (GVHD).
•Has a known additional malignancy that is progressing or requires active treatment in the last 3 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
•Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (i.e., without evidence of progression by repeat imaging), clinically stable and without requirement of steroid treatment for ≥14 days prior to the first dose of study drug.
•Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with the use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
•Has a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis.