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Clinical Trial Protocol

Neo-DREAM study investigating Daromun for the treatment of clinical stage IIIB/C melanoma

    John T Miura

    Departments of Cutaneous Oncology & Sarcoma, Moffitt Cancer Center, Tampa, FL 33612, USA

    Department of Surgery, University of South Florida School of Medicine, Tampa FL, USA

    &
    Jonathan S Zager

    *Author for correspondence: Tel.: +1 813 745 1085; Fax: +1 813 745 5725;

    E-mail Address: jonathan.zager@moffitt.org

    Departments of Cutaneous Oncology & Sarcoma, Moffitt Cancer Center, Tampa, FL 33612, USA

    Department of Surgery, University of South Florida School of Medicine, Tampa FL, USA

    Published Online:https://doi.org/10.2217/fon-2019-0433

    High-risk resectable melanoma poses therapeutic challenges as this subgroup remains most vulnerable for disease recurrence. Immunotherapy has established its efficacy in cases of advanced melanoma, and now is actively being investigated in the multimodal management of resectable disease. Daromun, an intralesional immunocytokine, has emerged as a unique immunotherapy in its ability to preferentially target tumor cells, resulting in direct destruction, while generating a bystander effect that leads to a distant treatment effect. On the basis of its mechanism of action, there is growing interest in delivering immune-based therapies in a neoadjuvant setting. In this review, the neo-DREAM study, a Phase III trial comparing the safety and efficacy of neoadjuvant Daromun for resectable stage IIIB/C melanoma will be described.

    Clinical Trial Registration Number: NCT03567889

    Papers of special note have been highlighted as: • of interest; •• of considerable interest

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