Study to Evaluate the Safety/ Efficacy of T-VEC in Japanese Subjects With Unresectable Stage IIIB-IV Malignant Melanoma
Condition: Unresectable Stage IIIB-IV Malignant Melanoma
MeSH terms: Melanoma
Intervention: Talimogene laherparepvec
Intervention description: Talimogene laherparepvec will be administered as an intralesional injection.
Intervention MeSH terms: Talimogene laherparepvec
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Unresectable Stage IIIB-IV Malignant Melanoma

Summary:

      There are 2 fold of purposes for this study. 1 is to evaluate safety and tolerability and the
      other is to study the anti-tumor effects of talimogene laherparepvec in Japanese participants
      with unresectable stage IIIB-IV malignant melanoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of melanoma

          -  Participants with stage IIIB to IVM1c melanoma that is not surgically resectable

          -  Participant who is treatment naive and is determined by the physician to be not
             suitable or eligible for the approved systemic anticancer drug therapy in Japan.
             Participant may also have received prior systemic anticancer treatment consisting of
             chemotherapy, immunotherapy, or targeted therapy. Treatment for melanoma must have
             been completed at least 28 days prior to enrollment.

          -  Candidate for intralesional therapy (ie, disease is appropriate for direct injection
             or through the use of ultrasound guidance, where appropriate) defined as one or more
             of the following:

               -  at least 1 injectable cutaneous, subcutaneous, or nodal melanoma lesion greater
                  or equal to 10 mm in longest diameter, OR

               -  multiple injectable melanoma lesions that in aggregate have a longest diameter of
                  greater or equal to 10 mm

          -  Measurable disease defined as one or more of the following:

               -  at least 1 melanoma lesion that can be accurately and serially measured in at
                  least 2 dimensions and for which the greatest diameter is greater or equal to 10
                  mm as measured by contrast-enhanced or spiral computed tomography (CT) scan,
                  magnetic resonance imaging (MRI), or ultrasound for nodal/soft tissue disease
                  (including lymph nodes)

               -  at least 1 greater or equal to 10 mm longest diameter superficial cutaneous or
                  subcutaneous melanoma lesion as measured by calipers

               -  multiple superficial melanoma lesions which in aggregate have a total diameter of
                  greater or equal to 10 mm

          -  Serum lactate dehydrogenase (LDH) levels less than or equal to 1.5 X upper limit of
             normal (ULN) within 28 days prior to enrollment

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Other Inclusion Criteria May Apply.

        Exclusion Criteria:

          -  Clinically active cerebral metastases. Participants with up to 3 cerebral metastases
             may be enrolled, provided that all lesions have been adequately treated with
             stereotactic radiation therapy (including Gamma Knife) or craniotomy, with no evidence
             of progression and have not required steroids for at least 2 months prior to
             enrollment.

          -  Greater than 3 visceral metastases (this does not include lung metastases or nodal
             metastases associated with visceral organs). For participants with less than or equal
             to 3 visceral metastases, no lesion greater than 3 cm in longest dimension and liver
             lesions must be stable for at least 1 month prior to enrollment.

          -  Bone metastases

          -  Primary ocular or mucosal melanoma

          -  History or evidence of symptomatic autoimmune disease (eg, pneumonitis,
             glomerulonephritis, vasculitis, or other), or history of autoimmune disease that
             required systemic treatment (ie, use of corticosteroids, immunosuppressive drugs or
             biological agents used for treatment of autoimmune diseases) in past 2 months prior to
             enrollment.

          -  Active herpetic skin lesions or prior complications of herpetic 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.

          -  Previous treatment with talimogene laherparepvec

          -  Other investigational procedures while participating in this study are excluded.

          -  Known to have acute or chronic active hepatitis B infection, acute or chronic active
             hepatitis C infection or human immunodeficiency virus (HIV) infection

          -  Participant has known sensitivity to bovine- or porcine derived components or to any
             of the products or components to be administered during dosing.

          -  History of other malignancy within the past 3 years

          -  Other Exclusion Criteria May Apply