EUCTR2017-000433-30-GB进行中（未招募）1 期
Phase II Trial of Pembrolizumab and Radiotherapy in Cutaneous T cell lymphoma - PORT
niversity College London0 个研究点目标入组 46 人开始时间: 2018年7月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 46
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
- •-Age = 18 years
- •-Diagnosis of Stage IB-IVB CTCL mycosis fungoides (MF)/Sézary Syndrome (SS)
- •-Have relapsed, are refractory or progressed after at least 1 systemic therapy
- •-Skin biopsy at the time of or within 6 months prior to study entry
- •-Patients must have a total mSWAT (modified Severity Weighted Assessment Tool)
- •score of =10 OR have 2 or more measurable tumours of any size. Of this area:
- •o There should be at least 1 cutaneous lesion (MF) or a defined area of involved
- •skin (erythrodermic MF or SS) which is an appropriate target for palliative
- •radiotherapy (see radiotherapy section 8.3.2 for protocol defined min/max
- •irradiated area)
- •o There should be an area of skin involved by measurable Mycosis Fungoides/SS
- •that will not be irradiated (to assess the abscopal effect of radiotherapy)
- •-Have a minimum wash-out and adverse event (AE) recovery period from previous treatments (e.g. topical therapy, phototherapy, local radiotherapy, monoclonal antibody, systemic cytotoxic anticancer treatment or other novel agents) prior to the first dose of pembrolizumab, as detailed in section 6.2.1 of the trial protocol
- •-Have ECOG performance status of 0 or 1
- •-Life expectancy of at least 6 months
- •-Demonstrate adequate organ function
- •-Female patients of childbearing potential must have a negative urine or serum pregnancy test at pre-registration
- •-Willing to comply with the contraception requirements
- •-Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •-Received chemotherapy or targeted small molecule therapy within 4 weeks prior to study entry or has not recovered from adverse events due to agents administered >4 weeks earlier (except patients with = grade 2 neuropathy)
- •-Is currently or has participated in an IMP or device study within 4 weeks prior to the first dose of pembrolizumab
- •-Received any other monoclonal antibody within 15 weeks prior to the first dose of pembrolizumab or has not recovered (= grade 1 or to baseline level) from adverse events due to agents administered >4 weeks earlier. The exception to this is alemtuzumab which should not have been administered in the previous 12 weeks.
- •-Additional malignancy that is progressing or requires active treatment
- •-Patients with known central nervous system (CNS) involvement with lymphoma
- •-Hypersensitivity to pembrolizumab or its excipients
- •-Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- •-Diagnosis of prior immunodeficiency or organ-transplant requiring immunosuppressive therapy
- •-Current or prior use of immunosuppressive therapy within 7 days prior to start of treatment except the following: intranasal, inhaled, topical steroids or local steroid injections (eg. Intra-articular injection); systemic corticosteroids at physiologic doses (10mg/day or less of prednisolone or equivalent)
- •-Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 therapy
- •-Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia
- •-Has known history of, or any evidence of active, non-infectious pneumonitis
- •-History of other pulmonary disease such as interstitial lung disease, emphysema or chronic obstructive pulmonary disease
- •-Is pregnant or breastfeeding
- •-Has a known history of active TB
- •-Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial or interfere with the subject’s participation for the full duration of the trial or to participate in the trial is not in the patient’s best interest, in the opinion of the treating investigator
- •-Has known psychiatric or substance abuse disorders that would interfere with the requirements of the trial
- •-Has a known history of HIV
- •-Has known active Hepatitis B or Hepatitis C
- •-Has received a live vaccine within 30 days prior to the planned start of study medication (see section 6.2.2 of the trial protocol)
- •-Patients who have previously received a solid organ transplant
- •-Patients who have previously received any allogeneic transplantation
研究者
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