NL-OMON52501招募中2 期
PEMbrolizumab Plus Lenvatinib In Second Line And Third Line Malignant Pleural MEsotheLiomA Patients. - PEMMELA
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 58 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 58
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Histologically or cytologically diagnosed malignant pleural mesothelioma,
- •age at least 18 years
- •2. 2. Progressive disease after at least 1 and maximal 2 prior systemic
- •treatment lines:
- •- Cohort 1: patients, in which one of the lines contains a platinum-based
- •doublet (both cisplatin and carboplatin are allowed) for unresectable MPM
- •- Cohort 2: patients with only in which one of the lines contains
- •nivolumab-ipilimumab immunotherapy as first line treatment for unresectable
- •MPM. No prior chemotherapy.
- •3. Measurable disease. At least one measurable lesion according to Modified
- •(i)RECIST for pleural mesothelioma. Lesions situated in a previously irradiated
- •area are considered measurable if progression has been demonstrated in such
- •4. WHO-ECOG performance status of 0 to 1. Evaluation of ECOG is to be performed
- •within 7 days prior to date of allocation
- •5. Adequate organ function
- •6. Ability to understand the study and give signed informed consent (or legally
- •acceptable representative if applicable) prior to beginning of protocol
- •specific procedures including the approval of the thoracoscopy or transthoracic
- •pleural biopsy before the first treatment cycle and an optional biopsy before
- •the third treatment cycle
- •7. No presence of clinically relevant treatment-related toxicity from previous
- •chemotherapy, targeted therapy and/or radiotherapy. Note: Participates must
- •have recovered from all AEs due to previous therapies to <=Grade 1 or baseline.
- •Participants with <=2 neuropathy may be eligible8. No active uncontrolled
- •infection, severe cardiac dysfunction (i.e. unstable angina, history of
- •myocardial infarction within the past 12 months prior to screening, congestive
- •heart failure > NYHA II, serious cardiac arrhythmia), unstable peptic ulcer,
- •unstable diabetes mellitus or other seriously disabling condition
- •9. Adequately controlled blood pressure (BP) with or without antihypertensive
- •medications, defined as BP <=150/90 mmHg at screening ad no change in
- •hypertensive medication within 1 week before the cycle 1/day1.
- •10. No prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with
- •another agent agents direct to another stimulatory or co-inhibitory T-cell
- •receptor (eg CTLA-4, OC-40, CD137) or TKI or antibody targeting angiogenesis in
- •the first cohort. Patients who have been treated with autologous tumor cell
- •vaccination (eg. Dendritic cell-based immunotherapy) will be eligible in the
- •first cohort.
- •11. No major injuries and/or surgery within the past 4 weeks prior to first
- •study dose with incomplete wound healing
- •12. No active autoimmune disease that has required systemic treatment in past 2
- •years (i.e., with use of disease modifying agents, corticosteroids or
- •immunosuppressive drugs).
- •13. A female is eligible if she is not pregnant and not breastfeeding. A male
- •participant who agrees to use contraception as detailed in age and reproductive
- •status breastfeeding
排除标准
- •1. presence of clinically relevant treatment-related toxicity from previous
- •chemotherapy, targeted therapy and/or radiotherapy. Note: Participates must
- •have recovered from all AEs due to previous therapies to <=Grade 1 or baseline.
- •Participants with <=2 neuropathy may be eligible
- •2. active uncontrolled infection, severe cardiac dysfunction (i.e. unstable
- •angina, history of myocardial infarction within the past 12 months prior to
- •screening, congestive heart failure > NYHA II, serious cardiac arrhythmia),
- •unstable peptic ulcer, unstable diabetes mellitus or other seriously disabling
- •3. prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with
- •another agent agents direct to another stimulatory or co-inhibitory T-cell
- •receptor (eg CTLA-4, OC-40, CD137) or TKI or antibody targeting angiogenesis in
- •the first cohort. Patients who have been treated with autologous tumor cell
- •vaccination (eg. Dendritic cell-based immunotherapy) will be eligible in the
- •first cohort.
- •4. concomitant administration to any other experimental drugs under
- •investigation <= 4 weeks prior to first admission of pembrolizumab- lenvatinib
研究者
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