Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Talimogene laherparepvec; 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: 437.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Melanoma; OncoVEX^GM-CSF; GM-CSF; Stage IIIb, IIIc and IV Disease; oncolytic; OncoVex; T-Vec; talimogene laherparepvec

Summary:

      The objective of this study is to evaluate the efficacy and safety of treatment with
      talimogene laherparepvec compared to subcutaneously administered GM-CSF in patients with
      unresectable Stage IIIb, IIIc and Stage IV melanoma. The efficacy endpoints of the study aim
      to demonstrate overall clinical benefit for patients treated with talimogene laherparepvec as
      compared to GM-CSF.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females age ≥ 18 years

          -  Stage IIIb, IIIc or stage IV disease that is not surgically resectable

          -  Injectable disease (i.e. suitable for direct injection or through the use of
             ultrasound guidance)

          -  At least 1 injectable cutaneous, subcutaneous or nodal melanoma lesion >= 10 mm in
             longest diameter or, multiple injectable melanoma lesions which in aggregate have a
             longest diameter of >= 10 mm

          -  Serum lactate dehydrogenase (LDH) levels less than 1.5 x upper limit of normal (ULN)

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Prolongation in International Normalized Ratio (INR), Prothrombin Time (PT), and
             Partial Thromboplastin Time (PTT) when the result is from therapeutic anticoagulation
             treatment are permitted for patients whose injectable lesions are cutaneous and/or
             subcutaneous such that direct pressure could be applied in the event of excessive
             bleeding

        Exclusion Criteria:

          -  Clinically active cerebral or any bone metastases. Patients 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 randomization

          -  Greater than 3 visceral metastases (this does not include lung metastases or nodal
             metastases associated with visceral organs). For patients with < 3 visceral
             metastases, no lesion > 3 cm, and liver lesions must meet Response Evaluation Criteria
             In Solid Tumors (RECIST) criteria for stable disease for at least 1 month prior to
             randomization