POLEM

  • Research type

    Research Study

  • Full title

    Avelumab plus fluoropyrimidine-based chemotherapy as adjuvant treatment for stage III dMMR or POLE exonuclease domain mutant colon cancer: A phase III randomised study.

  • IRAS ID

    224726

  • Contact name

    Tony Dhillon

  • Contact email

    tony.dhillon@nhs.net

  • Sponsor organisation

    The Royal Marsden NHS Foundation Trust

  • Eudract number

    2017-000370-10

  • Duration of Study in the UK

    9 years, 10 months, 29 days

  • Research summary

    In locally advanced colon cancer the standard of care is surgical resection and chemotherapy. Most patients are cured however not all of them are. To improve the cure rate we need to target sub groups of patients who are likely to respond to new drugs. We aim to look at 2 sub groups of patients - Mismatch repair deficient and POLE exonuclease mutant. We think that because of these tumours having a high mutational load, they are likely to respond to a new group of treatments called checkpoint inhibitors. This study will compare the standard of care - surgery and chemotherapy with this plus Avelumab - an immune checkpoint inhibitor. It will be a randomised study.

  • REC name

    London - West London & GTAC Research Ethics Committee

  • REC reference

    18/LO/0165

  • Date of REC Opinion

    9 May 2018

  • REC opinion

    Further Information Favourable Opinion