NL-OMON49601已完成2 期
eo-adjuvant Pembrolizumab in dMMR/ POLE-EDM uterine cancer patients: a feasibility study - PAM
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
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
- •- Female participants who are at least 18 years of age on the day of signing
- •informed consent with histologically confirmed primary diagnosis of
- •dMMR/POLE-EDM uterine cancer who are intended to be treated with hysterectomy
- •will be enrolled in this study.
- •- A female participant is eligible to participate if she is not pregnant, not
- •breastfeeding, is not a woman of childbearing potential (WOCBP) or agrees to
- •follow the contraceptive guidance in section 5.2 during the treatment period
- •and at least until standard-of-care hysterectomy.
- •- The participant (or legally acceptable representative if applicable) provides
- •written informed consent for the trial.
排除标准
- •- A woman who has a positive urine pregnancy test within 72 hours prior to
- •allocation.
- •- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2
- •agent or with an agent directed to another stimulatory or co-inhibitory T-cell
- •- Has received prior systemic anti-cancer therapy including investigational
- •agents within 4 weeks prior to allocation.
- •- Has received prior radiotherapy within 2 weeks of start of study treatment.
- •- Has received a live vaccine within 30 days prior to the first dose of study
- •- Is currently participating in or has participated in a study of an
- •investigational agent or has used an investigational device within 4 weeks
- •prior to the first dose of study treatment.
- •- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid
- •therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other
- •form of immunosuppressive therapy within 7 days prior to the first dose of
- •study drug.
- •- Has a known additional malignancy that is progressing or has required active
- •treatment within the past 3 years.
- •- Has known active CNS metastases and/or carcinomatous meningitis.
- •- Has severe hypersensitivity (>=Grade 3) to pembrolizumab and/or any of its
- •excipients.
- •- Has active autoimmune disease that has required systemic treatment in the
- •past 2 years
- •- Has a history of (non-infectious) pneumonitis that required steroids or has
- •current pneumonitis.
- •- Has an active infection requiring systemic therapy.
- •- Has a known history of Human Immunodeficiency Virus (HIV).
- •- Hepatitis B of C
- •- Has a history or current evidence of any condition, therapy, or laboratory
- •abnormality that might confound the results of the study, interfere with the
- •subject*s participation for the full duration of the study, or is not in the
- •best interest of the subject to participate, in the opinion of the treating
- •investigator.
- •- Has known psychiatric or substance abuse disorders that would interfere with
- •cooperation with the requirements of the trial.
- •- Is pregnant or breastfeeding, or expecting to conceive within the projected
- •duration of the study, starting with the screening visit through 120 days after
- •the last dose of trial treatment.
研究者
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