EUCTR2015-005053-12-PL进行中（未招募）1 期
A Phase III, Randomized, Open-label, Clinical Trial to Compare Pembrolizumab with Brentuximab Vedotin in Subjects with Relapsed or Refractory Classical Hodgkin Lymphoma - Phase III trial of pembrolizumab or brentuximab vedotin in Hodgkin lymphoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •– =18 years of age
- •– Relapsed or refractory classical Hodgkin lymphoma
- •– Measurable disease on spiral computed tomography (CT) or combined
- •CT/positron emission tomography (PET) scan
- •– Evaluable core or excisional lymph node biopsy
- •– Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •– Adequate organ function (laboratory studies)
- •– Negative pregnancy/lactation
- •– Adequate contraception (males and females)
- •Refer to the protocol for more detail on each inclusion criterion.
- •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 210
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •1. Has severe (= Grade 3) hypersensitivity to the active substance or to any of the excipients in BV or pembrolizumab. 2. 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 treatment. 3. Has a diagnosis of immunosuppression or is receiving systemic steroid therapy (exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- •4. Has had a prior monoclonal antibody within 4 weeks prior to first dose
- •of therapy in the study or who has not recovered (i.e., =Grade 1 or at
- •baseline) from AEs due to agents administered more than 4 weeks
- •5. 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.
- •6. Has undergone prior allo-SCT within the last 5 years.
- •7. Has a known additional malignancy that is progressing or has required
- •active treatment in the last 3 years.
- •8. Has known active central nervous system (CNS) metastases and/or
- •carcinomatous meningitis. Subjects with previously treated brain
- •metastases may participate provided they are radiologically stable (ie,
- •without evidence of progression for at least 4 weeks by repeat imaging
- •(note that the repeat imaging should be performed during study
- •screening), clinically stable, and without requirement of steroid
- •treatment for at least 14 days prior to the first dose of trial treatment.
- •9. 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).
- •10. Has a history of (non-infectious) pneumonitis that required steroids,
- •or current pneumonitis.
- •11. Has an active infection requiring intravenous systemic therapy.
- •12. Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the trial.
- •13. Is pregnant or breastfeeding, or expecting to conceive or father
- •children within the projected duration of the trial, starting with the
- •screening visit through 120 days after the last dose of pembrolizumab or
- •180 days after the last dose of BV
- •14. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2,
- •anti-CD137, CTLA-4 antibody (including ipilimumab), or OX-40, or any
- •other antibody or drug specifically targeting T-cell co-stimulation or
- •checkpoint pathways.
- •15. Has a known history of human immunodeficiency virus (HIV)
- •infection. No HIV testing is required unless mandated by local health
- •16. Has active hepatitis B (HBV) (e.g., HBsAg reactive) or hepatitis C
- •(HCV) (e.g., HCV RNA [qualitative] is detected).
- •17. Has received a live vaccine within 30 days prior to first dose.
- •18. Has a known history of active tuberculosis (TB; Bacillus
- •tuberculosis).
- •19. Is eligible for allogeneic or autologous stem cell transplantation per
- •investigator assessment.
研究者
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