EUCTR2016-002114-50-SE进行中（未招募）1 期
A multicenter phase II open label study to evaluate efficacy of concomitant use of pembrolizumab and entinostat in adult patients with metastatic uveal melanoma - PEMDAC
Sahlgrenska University Hospital0 个研究点目标入组 29 人开始时间: 2017年10月27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
- 29
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
- •Patient must have a histologically confirmed diagnosis of stage IV uveal melanoma. If tissue biopsy is judged not feasible by the investigator, cytological diagnosis from fine needle aspiration (FNA) will be accepted.
- •Patient may have received any number of prior systemic anticancer therapies (including none), with the exception of anticancer immunotherapy (see below).
- •Patient is willing and able to provide written informed consent and comply with study procedures. Written informed consent must be signed and dated before the start of specific protocol procedures.
- •Patient is =18 years of age on the day of signing informed consent.
- •Patient has a tumor sample (archived or newly obtained biopsy) that is adequate for HLA-expression analysis. Patients with an inadequate sample may undergo re- biopsy at the discretion of the investigator. If judged not feasible by the investigator, material from FNA will be accepted.
- •Patient has a performance status of 0 or 1 on the ECOG PS Scale.
- •Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria (Eisenhauer et al., 2009)
- •Patient must have adequate organ function as indicated by the following laboratory values obtained within 14 days of receiving the first dose of study drug:
- •Absolute neutrophil count =1.5x109/L
- •Platelets =100x109/L
- •Hemoglobin =9 g/dL or =5.6 mmol/L
- •Serum creatinine = 1.5 x upper limit of normal (ULN)
- •Total serum bilirubin = 1.5 x ULN OR Direct bilirubin = ULN for patients with total bilirubin levels >1.5 ULN
- •AST and ALT =2.5 x ULN OR?= 5 X ULN for patients with liver metastases
- •International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (aPTT) =1.5 x ULN unless subject is receiving anticoagulant therapy as long as INR or aPTT is within the therapeutic range of intended use
- •Female patient of childbearing potential (Section 7.6) should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •Female patients of childbearing potential (Section 7.6) must be willing to use an adequate method of contraception as outlined in Section 7.6 – Contraception, for the course of the study through 120 days after the last dose of study medication.
- •Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
- •Male patients of childbearing potential (Section 7.6) must agree to use an adequate method of contraception as outlined in Section 7.6 - Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.
- •Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
- •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 13
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •Patient has known active brain metastases. Patients previously treated for brain metastases, may participate if there is no clinical or radiological sign of progression or new brain metastases four weeks prior to receiving the first dose of study drug without the use of steroids or on stable or decreasing dose of =10 mg daily prednisone (or equivalent), and must be without neurologic dysfunction that would confound the evaluation of neurologic and other AEs. This exception does not include patients with a history of leptomeningeal metastases, which are excluded regardless of clinical stability
- •Patient has received prior treatment with anti-cancer immunotherapy (including, but not limited to: any anti-CTLA4, anti-PD-1, anti-PD-L1 or anti-PD-L2 agent, adoptive cell therapy, IL-2, interferon)
- •Has had a prior anti-cancer monoclonal antibody (mAb) 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, targeted small molecule therapy, radiation therapy or other locoregional anti-cancer therapy within 2 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
- •Note: Subjects with = Grade 2 neuropathy or = Grade 2 alopecia are exceptions to this criterion and may qualify for the study. Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
- •Patient has life expectancy of less than 3 months
- •Patient is currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of study drug
- •Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy or in situ cervical cancer
- •Patient with diagnosis of immune deficiency or treated with any systemic corticosteroids (>10 mg daily prednisone equivalents) or other systemic immunosuppressive medication within 7 days of study drug administration. The use of physiologic doses of corticosteroids (even >10 mg daily prednisone equivalents) may be approved after consultation with the Sponsor
- •Patient with active autoimmune disease or documented history of autoimmune disease that has required systemic treatment (e.g. corticosteroids, disease modifying agents or immunosuppressive medication) in past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment
- •Patient has a known allergy to benzamide (e.g. metoclopramide) or inactive components of entinostat
- •Currently receiving treatment with any other agent listed on the prohibited medication list
- •Patient previously had a severe hypersensitivity reaction to treatment with another mAb
- •Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study drug
- •Patient has received a live vaccine within 30 days of the first dose of treatment
- •Patient has a known active Hepatit
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