Expanded Access Protocol of Talimogene Laherparepvec for Subjects With Unresected, Stage lllB to IVM1c Melanoma

Inclusion Criteria:

Histologically confirmed diagnosis of melanoma
Subject has unresected stage lllB to IVM1c melanoma regardless of prior therapy
Subject who is not eligible for or cannot access ongoing talimogene laherparepvec clinical trials
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)
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Adequate organ function determined within 35 days prior to enrollment
Serum LDH levels less than or equal to 1.5 ULN within 35 days prior to enrollment
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

Exclusion Criteria:

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, craniotomy, gammaknife therapy, with no evidence of progression, and have not required steroids, for at least two (2) months prior to enrollment.
Greater than 3 visceral metastases (this does not include lung metastases or nodal metastases associated with visceral organs). For subjects with less than or equal to 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.
Bone metastases
Primary ocular or mucosal melanoma
History or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease
Evidence of clinically significant immunosuppression
Active herpetic skin lesions or prior complications of HSV-1 infection (eg, herpetic keratitis or encephalitis)
Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use
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)
Other investigational procedures while participating in this protocol are excluded
Known to have acute or chronic active hepatitis B or hepatitis C infection
Known to have human immunodeficiency virus infection
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 or lentigo maligna 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
Subject has known sensitivity to any of the products or components to be administered during dosing
History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen medical monitor, if consulted, would pose a risk to subject safety or interfere with the protocol evaluation, procedures or completion
Female subject is pregnant or breast-feeding, or planning to become pregnant during protocol treatment and through 3 months after the last dose of talimogene laherparepvec
Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during protocol treatment and through 3 months after the last dose of talimogene laherparepvec