MO29518 - A phase II Study of MPDL3280A in Advanced Solid Tumours

• Research type

  Research Study

• Full title

  AN OPEN-LABEL, MULTICOHORT, PHASE II STUDY OF MPDL3280A IN ADVANCED SOLID TUMOURS

• IRAS ID

  178738

• Contact name

  Christian Ottensmeier

• Contact email

  cho@soton.ac.uk

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Eudract number

  2015-000269-30

• Duration of Study in the UK

  4 years, 5 months, 19 days

• Research summary

  Patients in this study will have received previous systemic treatment, including surgery, radiation and/or chemotherapy for their solid tumour(s). Moreover, it’s likely that all standard therapeutic options for their advancing, treatment-refractory disease will have been exhausted and their overall prognosis is consequently bleak.
  Encouraging clinical data on tumour immunotherapy have demonstrated that therapies focused on enhancing T-cell responses can result in a significant survival benefit in patients with advanced malignancies.

  The PD-L1 pathway is involved in regulating the body’s natural immune response, but tumours can take advantage of this regulation to partially resist or evade the immune system.

  Targeting the PD-L1 pathway with MPDL3280A has demonstrated activity in patients with advanced malignancies who have failed standard of care therapies.
  In order to maximize potential patient benefit, substantial effort has been made to choose patients for enrolment who are most likely to benefit from MPDL3280A therapy. Academic experts were queried and relevant published literature was reviewed to identify 10 solid tumour types that:
  • Were likely to have high immunogenicity and respond to therapies that increase antitumor immunity
  • Had published evidence indicating a direct role of PD-L1 expression on clinical outcomes, including prognosis and treatment outcomes.

  The primary aim of this study is to examine the efficacy and safety of MPDL3280A in patients with different advanced solid tumours. A total of 250 patients (15 in UK) will be enrolled across 10 cohorts. Patients will receive 1200 mg MPDL3280A intravenously on day 1 of each 21 day cycle. In the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression patients will receive MPDL3280A as long as they continue to experience clinical benefit in the opinion of the investigator.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  15/SC/0291

• Date of REC Opinion

  8 Jun 2015

• REC opinion

  Favourable Opinion