An Extended Use Study of Safety and Efficacy of Talimogene Laherparepvec in Melanoma
An Extended Use Study of Safety and Efficacy of Talimogene Laherparepvec in Melanoma
The purpose of this study is to learn about the safety and the risks of using talimogene
 laherparepvec in patients who already received treatment with talimogene laherparepvec in
 study 005/05 (NCT00769704), and to see if extended treatment with talimogene laherparepvec
 can destroy melanoma tumors.
Inclusion Criteria:

 1. Previously participated in protocol 005/05 (NCT00769704) and:

 1. received the maximum number of talimogene laherparepvec treatment injections or
 cycles of GM-CSF allowable for that patient on study 005/05, or

 2. new injectable lesion(s) appeared after previous resolution of all injectable
 disease while on study 005/05. New injectable lesions must have appeared within ≤
 12 months from the End of Treatment visit on the 005/05 study.

 2. In the opinion of the investigator and the sponsor's medical monitor further treatment
 is warranted [e.g., those patients who do not have clinically relevant progressive
 disease (PDr)].

 3. Performance status (Eastern Cooperative Oncology Group, ECOG) 0 or 1.

 4. For patients randomized to talimogene laherparepvec only: Injectable disease (i.e.
 suitable for direct injection or through the use of ultrasound guidance) defined as at
 least 1 injectable cutaneous, subcutaneous or nodal melanoma lesion. There is no
 minimum size for injection.

 Exclusion Criteria:

 1. Prior Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or 4 toxicity
 related to talimogene laherparepvec of any organ system (with the exception of
 injection site reactions, fever and vomiting).

 2. History of Grade 3 fatigue lasting > 1 week while on talimogene laherparepvec
 treatment.

 3. History of Grade 3 arthralgia/myalgias while on talimogene laherparepvec treatment.

 4. History of ≥ Grade 2 autoimmune reactions, allergic reactions or urticaria or other
 talimogene laherparepvec related non-hematological toxicities while on talimogene
 laherparepvec treatment that required a dose delay or discontinuation of talimogene
 laherparepvec therapy.

 5. PDr while participating in study 005/05

 6. Patient requested to be withdrawn from study 005/05 or was unable to comply with the
 demands of the 005/05 trial.

 7. At the discretion of the investigator, patient was withdrawn from the 005/05 trial.