An Extended Use Study of Safety and Efficacy of Talimogene Laherparepvec in Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Talimogene Laherparepvec; Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF)
Intervention description: Up to 4 mL of 10⁸ pfu/mL/per intratumoral injection; 125 µg/m² subcutaneous injection
Intervention MeSH terms: Molgramostim; Talimogene laherparepvec; Sargramostim
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Melanoma; Stage IIIb, IIIc and IV Disease; oncolytic; OncoVex; OncoVEX^GM-CSF

Summary:

      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.
    

Eligibility criteria:

        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.