EUCTR2015-002406-37-FR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) - A phase II study of pembrolizumab in subjects with relapsed or refractory PMBC
Merck Sharp & Dohme Corp., a subsidiary of Merck Co., Inc0 个研究点目标入组 53 人开始时间: 2016年1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
- 53
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
- •- Confirmed diagnosis of Primary Mediastinal Large B-cell lymphoma by independent central review, according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues (WHO Criteria 2008 [52].
- •- Subject must be able to provide an evaluable core or excisional lymph node biopsy for confirmation of PMBCL diagnosis from an archival or newly obtained biopsy at Screening. In addition subjects may be asked to provide additional biopsy samples, if possible, at Week 12 and at the time of discontinuation due to progression for biomarker analysis.
- •- Have relapsed*a or refractory*b Primary Mediastinal Large B-cell lymphoma and:
- •- Have relapsed after auto-SCT or have failed to achieve a Complete Response 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.
- •- 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 spiral computed tomography (CT) scan. Minimum measurement must be > 15 mm in the longest diameter.
- •- Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
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.
- •- Has a known history of immunosuppression or is receiving systemic steroid therapy or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
- •- Has had a prior monoclonal antibody 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 agents administered more than 4 weeks earlier.
- •- 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.
- •- Has undergone prior allogeneic hematopoetic stem cell transplantation within the last 5 years. (Subjects 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. 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 CNS involvement. Subjects with prior CNS involvement are eligible if their CNS disease is in radiographic, cytological (for CSF 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 treatment
- •- Has evidence of active, non-infectious 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-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- •- Has a known Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), or Hepatitis C (HCV) infection.
- •- Has received a live vaccine within 30 days prior to first dose.
研究者
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