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  • DV3- MEL-01

    Acronym: 

    DV3- MEL-01

    ACTRN/NCT /ethics: 

    NCT02521870

    Scientific title: 

    A Phase 1b/2, Open-label, Multicenter, Dose-escalation and Expansion Trial of Intratumoral SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

    Summary of trial and patient characteristics

    Cancer Type Melanoma & other skin, Head and Neck
    Trial Type Treatment
    Phase Phase I, Phase II Tumour Stream Head & Neck
    Age Range 18 years and older Cancer Stage Locally Recurrent or Locally Advanced, Metastatic or Widespread
    Sex Both Anticipated Start Date 2015-09-01
    Molecular Target Anticipated End Date 2020-02-01
    Cancer Type Melanoma & other skin, Head and Neck
    Trial Type Treatment
    Phase Phase I, Phase II
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Head & Neck
    Cancer Stage Locally Recurrent or Locally Advanced, Metastatic or Widespread
    Anticipated Start Date 2015-09-01
    Anticipated End Date 2020-02-01

    Trial Summary

    This is a phase 1b/2, open-label, multicenter trial designed to evaluate the safety, tolerability, biologic activity, and preliminary efficacy of intratumoral SD 101 injections in combination with intravenous pembrolizumab in patients with metastatic melanoma or recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Phase 1 of this trial is a modified 3+3 dose escalation study evaluating escalating or intermediate dose levels of SD-101 given with a fixed dose of pembrolizumab in patients with metastatic melanoma. Phase 2 of this study will consist of 4 expansion cohorts to further evaluate the efficacy and safety of SD-101 given in combination with pembrolizumab in specific melanoma and HNSCC populations: For each of the indications in melanoma and HNSCC 2 separate cohorts will be recruited, those who are anti-programmed death receptor-1/ligand 1 (anti-PD-1/L1) therapy and those who have progressive disease (PD) while receiving anti-PD-1/L1 therapy.

    Lay Summary

    A Phase 1b/2, Open-label, Multicenter, Dose-escalation and Expansion Trial of Intratumoral SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

    Sponsor / Cooperative group

    Dynavax Technologies Corporation

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Ashford Cancer Centre Research Helen Daykin hdaykin@adelaidecancercentre.com.au 08 8292 2240 Recruiting