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  • MASTERKEY-115

    Acronym: 

    MASTERKEY-115

    ACTRN/NCT /ethics: 

    NCT04068181

    Scientific title: 

    Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115)

    Summary of trial and patient characteristics

    Cancer Type Melanoma & other skin
    Trial Type Treatment
    Phase Phase II Tumour Stream Melanoma
    Age Range 18 years and older Cancer Stage Metastatic or Widespread
    Sex Both Anticipated Start Date 2020-01-27
    Molecular Target Anticipated End Date 2023-10-24
    Cancer Type Melanoma & other skin
    Trial Type Treatment
    Phase Phase II
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Melanoma
    Cancer Stage Metastatic or Widespread
    Anticipated Start Date 2020-01-27
    Anticipated End Date 2023-10-24

    Trial Summary

    This is a phase 2, open-label, single-arm, multicenter clinical trial designed to evaluate the efficacy and safety of talimogene laherparepvec in combination with pembrolizumab following disease progression on prior anti-PD-1 therapy in unresectable/metastatic melanoma (stage IIIB-IVM1d) or prior anti-PD-1 therapy in the adjuvant setting. Subjects will be treated with talimogene laherparepvec and pembrolizumab until confirmed complete response, disappearance of all injectable lesions, documented confirmed disease progression per modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST), intolerance of study treatment, or 102 weeks from the first dose of talimogene laherparepvec and/or pembrolizumab, whichever occurs first.

    Lay Summary

    Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115)

    Sponsor / Cooperative group

    Amgen

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    The Queen Elizabeth Hospital Pamela Cooper pamela.cooper@sa.gov.au 08 8222 6140 Dr Rachel Roberts-Thomson Recruiting