Author of

• 17842

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  P2.06 - Poster Session with Presenters Present (ID 467)

  • Event: WCLC 2016
  • Type: Poster Presenters Present
  • Track: Scientific Co-Operation/Research Groups (Clinical Trials in Progress should be submitted in this category)
  • Presentations: 1
  • Moderators:
  • Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 17867

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    P2.06-025 - DREAM - A Phase 2 Trial of DuRvalumab with First Line chEmotherApy in Mesothelioma with a Safety Run In (ID 4412)

    14:30 - 14:30  |  Author(s): M. Stockler
    • Abstract

    Background:
    Immunotherapy is active in malignant pleural mesothelioma (MPM). Durvalumab is a human monoclonal antibody directed against the programmed cell death ligand 1 (PD-L1). We hypothesize that the addition of durvalumab to first-line chemotherapy improves 6-month progression free survival (PFS6).
    
    Methods:
    DESIGN: Open-label, single arm, multi-centre, phase 2 trial with a safety run in. ELIGIBILITY: Adults with MPM starting first-line cisplatin and pemetrexed. ENDPOINTS: PFS6 (primary) and objective tumour response rate using modified RECIST for MPM and modified immune-related response criteria; adverse events and overall survival. Tertiary correlative objectives include associations between potential predictive/prognostic biomarkers and clinical outcomes. TREATMENT: Durvalumab 1125mg (dose to be confirmed in safety run-in), cisplatin (75mg/m[2]) and pemetrexed (500mg/m[2]) 3-weekly for a maximum of 6 cycles, followed by durvalumab alone until progression or for a maximum of an addition of 12 cycles. STATISTICS: 6 participants in an initial safety run-in using a 3+3 design, will be included in the total sample size of 54 evaluable participants, consisting of 31 recruited in stage 1, and another 23 in stage 2. The null hypothesis is that the true PFS6 rate is 45%, in keeping with standard therapy and would be considered not worthy of further evaluation. The two-stage design provides greater than 90% power with a one-sided type I error rate of 5% if the true PFS6 rate is 65% (alternate hypothesis). ASSESSMENT: CT scans 6-weekly for the first 30 weeks, then 9-weekly until disease progression. Translational research blood collections: baseline, cycle 2 and 3.
    
    Results:
    Central ethics submission has been completed and recruitment will be updated.
    
    Conclusion:
    DREAM is an investigator-initiated cooperative-group trial led by ALTG, in collaboration with NHMRC Clinical Trials Centre, University of Sydney, with support from Astra-Zeneca.