Expanded Access Study of Talimogene Laherparepvec of Subjects in Europe with late stage Melanoma
- Conditions
- nresectable, Stage IIIB to IVM1c MelanomaMedDRA version: 20.0 Level: LLT Classification code 10053571 Term: Melanoma System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-002834-30-AT
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 11
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method