EUCTR2015-002406-37-SE进行中（未招募）1 期
A Phase 2 Study of Pembrolizumab (MK 3475) in Subjects with Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) or Relapsed or Refractory Richter Syndrome (rrRS) - A phase II study of pembrolizumab in subjects with relapsed or refractory PMBCL/rrRS
Merck Sharp & Dohme Corp., a subsidiary of Merck Co., Inc0 个研究点目标入组 106 人开始时间: 2015年12月14日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 106
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Diagnosis of PMBCL, according to the World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues (WHO Criteria 2008).
- •- Subject must be able to provide an evaluable core or excisional lymph node biopsy for evaluation of PMBCL diagnosis from an archival or newly obtained biopsy at Screening. (Central review is not required before enrolment. Enrolment can be done on local pathologic review for diagnosis.)
- •- Have relapsed or refractory PMBCL and:
- •* Have relapsed after auto-SCT or have failed to achieve a CR or PR within 60 days of auto-SCT. Subjects may have received intervening therapy after auto-SCT for relapsed or
- •refractory disease, in which case they must have relapsed after or be refractory to their last treatment.
- •* For subjects who are ineligible for auto-SCT, have received at least = 2 lines of prior therapy and have failed to respond to or relapsed after their last line of treatment. For subjects who received consolidative local radiotherapy after systemic therapy, local radiotherapy will not be considered as a separate line of treatment.
- •- Must have been previously exposed to rituximab as part of prior lines of treatment.
- •Richter Syndrome:
- •- Pathologic diagnosis per local institutional review of Richter syndrome that transformed from CLL.
- •- Have relapsed or refractory RS and has received at least 1 previous treatment for RS.
- •All Subjects:
- •- Have radiographically measureable disease by independent central review, defined as at least one lesion that can be accurately measured in at least two dimensions with appropriate anatomic imaging (CT scan or magnetic resonance imaging [MRI]). Minimum measurement must be > 15 mm in the longest diameter.
- •a. RS subject must also be PET positive at screening, defined as having at least one lesion, attributable to malignancy and with appropriate correlation to anatomic imaging, with uptake greater than that of normal liver tissue.
- •- Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
- •- Life expectancy > 3 months
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- •- Is receiving systemic steroid therapy < 3 days before the first dose of trial treatment or receiving any other form of immunosuppressive medication.
- •a. Corticosteroid use on study after Cycle 1 for management of AEs, SAEs and ECIs, as a
- •premedication for IV contrast allergies/reactions, or if considered necessary for a subject's welfare is allowed.
- •b. Subjects who receive daily steroid replacement therapy are an exception. Daily prednisone at doses of 5 to 7.5 mg is an example of replacement therapy.
- •c. Equivalent hydrocortisone doses are also permitted if administered as replacement therapy.
- •- Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 (2 week for RS subjects) or who has not recovered (i.e. = Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier (2 weeks for RS subjects).
- •- Has had prior chemotherapy or targeted small molecule therapy within 2 weeks prior to study Day 1 or has had prior radiation therapy within 4 weeks prior to study Day 1 or who has not recovered (i.e. = Grade 1 or at baseline) from adverse events due to a previously administered agent.
- •Exception: Subjects with RS with CLL may receive ibrutinib (or similar for CLL) up to 24 hours before first dose.
- •- Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Subjects who have had a transplant greaterthan 5 years ago are eligible as long as there are no symptoms of Graft versus Host Disease (GVHD).
- •- Has a known additional malignancy (except underlying CLL for RS) that is progressing or requires active treatment. 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) involvement. Subjects with prior CNS involvement are eligible if their CNS disease is in radiographic, cytological (for cerebrospinal fluid disease) and clinical remission.
- •- Has active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic
- •- Has a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis.
- •- Has an active infection requiring intravenous systemic therapy.
- •- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA- 4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- •- Has a known history of Human Immunodeficiency Virus (HIV 1 and 2 antibodies), or known active Hepatitis B (Hepatitis B surface antigen reactive), or Hepatitis C (Hepatitis C virus RNA [qualitative] is detected).
- •- Has received a live vaccine within 30 days prior to first dose.
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