EUCTR2014-002834-30-AT进行中（未招募）1 期
A Phase 3b, Multicenter, Open-label, Single-arm, Expanded Access Protocol of Talimogene Laherparepvec for the Treatment of Subjects in Europe With Unresected Stage IIIB to IVM1c Melanoma
Amgen Inc.0 个研究点目标入组 11 人开始时间: 2015年4月28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
- 11
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
入选标准
- •101 Subject has provided informed consent prior to initiation of any protocol-specific activities/procedures
- •102 Male or female age = 18 years at the time of informed consent
- •103 Histologically confirmed diagnosis of melanoma
- •104 Subject has unresected stage lllB to IVM1c melanoma regardless of prior therapy
- •105 Subject who is not eligible for or cannot access ongoing talimogene
- •laherparepvec clinical trials
- •106 Subject does not qualify for, or cannot access, other comparable or satisfactory alternative therapy for stage IIIB to IVM1c melanoma
- •107 Candidate for intralesional therapy (ie, disease is appropriate for direct injection or through the use of ultrasound guidance) defined as one of the following:
- •for a subject not previously treated with talimogene laherparepvec:
- •- at least 1 injectable cutaneous, subcutaneous, or nodal melanoma lesion = 10 mm in longest diameter, or
- •- multiple injectable melanoma lesions that in aggregate have a longest diameter of = 10 mm
- •for a subject previously treated with talimogene laherparepvec:
- •- at least 1 injectable cutaneous, subcutaneous, or nodal melanoma lesion must be present (no minimal size criteria)
- •108 Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •109 Adequate organ function determined within 35 days prior to enrollment, defined as follows:
- •absolute neutrophil count = 1500/mm3
- •platelet count = 75,000/mm3
- •hemoglobin = 8 g/dL without need for hematopoietic growth factor or
- •transfusion support
- •serum creatinine = 1.5 x upper limit of normal (ULN)
- •serum bilirubin = 1.5 x ULN
- •aspartate amino-transferase (AST) = 2.5 x ULN
- •alanine amino-transferase (ALT) = 2.5 x ULN
- •alkaline phosphatase = 2.5 x ULN
- •serum albumin = 2.5 g/dL
- •prothrombin time (PT) or international normalization ratio (INR)= 1.5 x ULN*
- •partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) = 1.5 x ULN*
- •* prolongation in INR, PT, and PTT when the result is from therapeutic
- •anticoagulation treatment are permitted for subjects whose injectable lesions are cutaneous and/or subcutaneous such that direct pressure could be applied in the event of excessive bleeding
- •110 Serum LDH levels = 1.5 ULN within 35 days prior to enrollment
- •111 For a subject who previously received talimogene laherparepvec in another clinical trial, subject must have ended treatment for reason(s) other than disease progression or intolerability to talimogene laherparepvec
- •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 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •201 Clinically active cerebral metastases. Subjects with up to 3 (neurological performance status of 0) cerebral metastases may be enrolled, provided that all lesions have been adequately treated with stereotactic radiation therapy, including Gamma Knife therapy, or craniotomy, with no evidence of progression, and have not required steroids, for at least 2 months prior to enrollment.
- •202 Greater than 3 visceral metastases (this does not include lung metastases or nodal metastases associated with visceral organs). For subjects with = 3 visceral metastases, no lesion > 3 cm, and liver lesions must meet RECIST criteria for stable disease for at least 1 month prior to enrollment.
- •203 Bone metastases
- •204 Primary ocular or mucosal melanoma
- •205 History or evidence of symptomatic autoimmune pneumonitis,
- •glomerulonephritis, vasculitis, or other symptomatic autoimmune disease
- •206 Evidence of clinically significant immunosuppression such as the following:
- •primary immunodeficiency state such as Severe Combined
- •Immunodeficiency Disease
- •concurrent opportunistic infection
- •receiving systemic immunosuppressive therapy (> 2 weeks), including oral steroid doses > 10 mg/day of prednisone or equivalent
- •207 Active herpetic skin lesions or prior complications of HSV-1 infection (eg, herpetic keratitis or encephalitis)
- •208 Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use
- •209 Currently receiving treatment with another investigational device or drug study besides talimogene laherparepvec, or less than 28 days since ending treatment with another investigational device or drug study(s)
- •210 Other investigational procedures while participating in this protocol are excluded
- •211 Known to have acute or chronic active hepatitis B infection
- •212 Known to have acute or chronic active hepatitis C infection
- •213 Known to have human immunodeficiency virus infection
- •214 History of other malignancy within the past 3 years with the following exceptions:
- •malignancy treated with curative intent and with no known active disease present for = 3 years before enrollment and felt to be at low risk for
- •recurrence by the treating physician
- •adequately treated non-melanoma skin cancer without evidence of disease
- •adequately treated cervical carcinoma in situ without evidence of disease
- •adequately treated breast ductal carcinoma in situ without evidence of disease
- •prostatic intraepithelial neoplasia without evidence of prostate cancer
- •adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ
- •215 Subject has known sensitivity to any of the products or components to be administered during dosing
- •216 Subject likely to not be available to complete all protocol-required visits or procedures, and/or to comply with all required protocol procedures to the best of the subject’s and investigator’s knowledge
- •217 History or evidence of any other clinically significant disorder
研究者
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