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Phase II study of TVEC with Pembro for Stage IIIB-IVM1c Melanoma

Phase 2 Study of Talimogene Laherparepvec in Combination With Pembrolizumab in Subjects With Unresectable/Metastatic Stage IIIB-IVM1c Melanoma Who Have Progressed on Prior Anti-PD-1 Based Therapy

  • Clinical Trial Information

    Trial Contact: Frankos, Marie; Tan, Ciara Natasha

    Trial Phone: 321.841.7303 ; 321.841.7413

  • IRB No: S19.276.11

    Protocol Abbrev: AMGEN 20180115

    Principal Investigator: Sajeve Samuel Thomas, MD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: MASTERKEY-115

    Treatment: Talimogene laherparepvec and pembrolizumab are administered at a once every 3 weeks (Q3W) frequency. When they are administered on the same day, talimogene laherparepvec should be administered first when possible.

    Therapies Involved: Medication;Oncology: Adjuvant

    ClinicalTrials.gov ID: 04068181

  • Objective

    To evaluate the efficacy of talimogene laherparepvec in combination with pembrolizumab as assessed by ORR in subjects with unresectable/metastatic stage IIIB-IVM1c melanoma who have
    progressed on prior anti-PD-1 therapy

  • Key Eligibility

    This study will enroll subjects who are male or female age > 18 years at the time of informed consent with histologically confirmed diagnosis of melanoma (unresectable or
    metastatic stage IIIB, IIIC, IIID, IVMIa, IVM1b, or IVM1c melanoma). Subjects must have measurable disease and be a candidate for intralesional therapy. Subjects must
    have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 and adequate hematologic, hepatic, renal, and coagulation function. Subject must also have received prior anti-PD-1 therapy for at least 2 to 3 consecutive cycles within
    8 weeks and have disease progression as defined by RECIST v1.1 criteria.