Phase 3 Study for Treatment of Stage 3 Melanoma

A Phase 1b/3, Multicenter Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresectable, Stage IIIB to IVM1c Melanoma

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Frankos, Marie; Ford, Elizabeth

    Trial Phone: 321.841.7303 ; 321.841.7413

  • IRB No: 16.074.06

    Protocol Abbrev: Amgen-TVeC

    Principal Investigator: Sajeve Samuel Thomas, MD

    Sub Investigators: Landau, Daniel MD; Kayaleh, Omar MD; Nair, Rajesh M.D.; Yang, Dianna D.O. ; Azbel, Alexander MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: 20110265

    Treatment: Oncology: 1st line

    Applicable Disease Sites: Melanoma

    Therapies Involved: Pembrolizumab ID: NCT02263508

  • Objective

    Subjects will be treated with talimogene laherparepvec plus pembrolizumab(arm 1) or placebo plus pembrolizumab (arm 2) until 24 months from the date of the first dose of pembrolizumab or end of treatment due to disappearance of injectable lesions, complete response, disease progression per irRC-RECIST or intolerance of study treatment.

  • Key Eligibility

    Age ≥ 18 years with histologically confirmed diagnosis of melanoma and stage IIIB to IVM1c for whom surgery is not recommended