Author of

• 12413

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  P3.04 - Poster Session 3 - Tumor Immunology (ID 155)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Biology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/30/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 12415

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    P3.04-002 - A phase II trial to assess the safety and immunological activity of Trovax plus pemetrexed/cisplatin in patients with malignant pleural mesothelioma - SKOPOS trial (ID 1837)

    09:30 - 09:30  |  Author(s): Z. Tabi
    • Abstract

    Background
    Malignant pleural mesothelioma (MPM) is an incurable and fatal malignancy of the pleural membranes. MPM has a poor prognosis and patients have a median survival of 9-13 months in clinical studies, with above 1,500 cases in the UK per year. No surgical approach has been shown to prolong survival and pemetrexed-cisplatin is now seen as the chemotherapy standard of care in the UK. However it is clear that new therapeutic strategies are urgently needed for MPM. Immunotherapy is potential new treatment approach to be considered in MPM, as the disease has been shown to respond to various immunotherapeutic strategies tested in animal models and early phase clinical trials. TroVax® consists of a highly attenuated vaccinia virus containing the human TAA 5T4 glycoprotein gene under regulatory control of a modified VV promoter, mH5. Velindre NHS Trust and the Wales Cancer Trials Unit (WCTU) have developed the SKOPOS trial to evaluate whether TroVax® is active in the treatment of MPM. SKOPOS is funded by the June Hancock Mesothelioma Research Fund, and the Velindre Cancer Centre Stepping Stones Appeal. Oxford BioMedica (UK) Ltd. is providing TroVax® vaccine free of charge, and also labeling and distribution costs. The trial is sponsored by Velindre NHS Trust, and coordinated by the WCTU.

    Methods
    A UK single centre, single arm, phase II trial. Eligible patients include locally advanced or metastatic, histologically or cytologically proven MPM, WHO performance status 0-1, life expectancy > 6months, at least four weeks since any previous therapy (surgery, radiotherapy). Enrolled patients will be treated with: TroVax® - intramuscular injection, dose 1 x 10[9] TCID ~50~/ml in 1ml, given on Day 1 of weeks 1, 3, 6, 9, 12, 15, 18, 21, 24. Folic Acid - 400μg oral daily from Day 2 of week 3 to Day 2 of week 16 B12 Vitamin – 1000μg intramuscular, Day 2 of weeks 3 and 12 Dexamethasone –4mg BD, Days 2-6 of weeks 4, 7, 10, 13 Pemetrexed - 500 mg/m[2] over 10 min, given on day 3 of weeks 4, 7, 10, 13 Cisplatin - 75mg/m[2] over 1h, given on day 3 of weeks 4, 7, 10, 13 The co-primary endpoints of the trial are i) cellular response to 5T4 and MVA antigens measured by intracellular cytokine staining (ICCS); and ii) antibody response to 5T4 and MVA antigens as measured by ELISA. Secondary outcome measures include safety, progression free survival, objective response rate and overall survival. The sample size was determined using Fleming’s single arm design. The outcome measure is the immune response to the 5T4 antigen. A success in this trial is defined as an increased response (at least a doubling in the 5T4 antibody or T-cell response) from that measured at baseline at any of the six follow-up time points. If an increased response is seen in at least 64% of patients then we will research the vaccine further in this group of patients. Using Fleming’s single-stage design, p1=0.40 and p2=0.64, setting alpha=0.05 (1-sided) and 80% power, 26 participants are required.

    Results
    Not Applicable

    Conclusion
    Not applicable