Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Melanoma
Condition: Completely Resectable Stage IIIB, IIIC, or IVM1a Melanoma
MeSH terms: Melanoma
Intervention: Talimogene Laherparepvec; Immediate surgical resection of melanoma lesion(s)
Intervention description: Talimogene laherparepvec will be administered by intralesional injection into the injectable cutaneous, subcutaneous, and nodal tumors initially at a dose of 10^6 plaque forming units (PFU)/mL at day 1 of week 1 followed by a dose of 10^8 PFU/mL at day 1 (±3 days) of week 4, 6, 8, 10 and 12 or until all injectable tumors have disappeared, or intolerance of study treatment or in the opinion of the investigator, immediate surgical resection or any other treatment for melanoma is warranted, whichever occurs first.; Surgical resection of melanoma tumor lesion(s) will be performed after randomization any time during weeks 1 to 6.
Intervention MeSH terms: Talimogene laherparepvec
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a phase 2, multicenter, randomized, open-label study to estimate the efficacy of
      talimogene laherparepvec as a neoadjuvant treatment followed by surgery compared to surgery
      alone in subjects with completely resectable stage IIIB, IIIC, or IVM1a melanoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of stage IIIB, IIIC or IVM1a melanoma eligible for
             complete surgical resection.

          -  Prior systemic, regional and radiation anticancer therapies for melanoma must have
             been completed at least 3 months prior to randomization.

          -  Subject must have measurable disease and must be a candidate for intralesional therapy
             with at least one injectable cutaneous, subcutaneous, or nodal melanoma lesion (≥ 10
             mm in longest diameter) or with multiple injectable lesions that in aggregate have a
             longest diameter of ≥ 10 mm.

          -  Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0
             or 1 and must have a serum lactate dehydrogenase (LDH) ≤ 1.0 X upper limit of normal
             and adequate hematologic, hepatic, renal, and coagulation organ function- Other
             criteria may apply

        Exclusion Criteria:

          -  Subject must not have primary ocular or mucosal melanoma, or history or evidence of
             melanoma associated with immunodeficiency states (eg, hereditary immune deficiency,
             organ transplant, or leukemia).

          -  Subject must not have history or evidence of symptomatic autoimmune pneumonitis,
             glomerulonephritis, vasculitis, or other symptomatic autoimmune disease.

          -  Subject must not have evidence of clinically significant immunosuppression or active
             herpetic skin lesions or prior complications of herpes simplex type 1 (HSV-1)
             infection (eg, herpetic keratitis or encephalitis) and must not require intermittent
             or chronic systemic treatment with an antiherpetic drug (eg, acyclovir), other than
             intermittent topical use.

          -  Subject known to have acute or chronic active hepatitis B, hepatitis C, or human
             immunodeficiency virus infection will also be excluded.

          -  Subject must not have been treated previously with talimogene laherparepvec or tumor
             vaccine.

        Other criteria may apply