Study Protocol: 1408P1921

  • Research type

    Research Study

  • Full title

    A multicenter, open-label, phase 2 study of S-588410 as maintenance monotherapy after first-line platinum-containing chemotherapy in patients with advanced and/or metastatic bladder cancer

  • IRAS ID

    152581

  • Contact name

    Syed Hussain

  • Contact email

    Syed.Hussain@liverpool.ac.uk

  • Sponsor organisation

    Shionogi & Co., Ltd

  • Eudract number

    2013-005274-22

  • Research summary

    The purpose of this study is to see if S-588410 is safe and effective as maintenance therapy in bladder cancer patients who have received chemotherapy and whose disease is stable. S-588410 is an experimental medicine (a “cancer peptide vaccine”) which has not yet been licensed for use.
    S-588410 is a cancer peptide vaccine. Cancer peptide vaccine therapy uses the body’s own immune system to treat cancer. The immune system is the body’s natural way of fighting disease. It is capable not only of eliminating invading bacteria or viruses, but also cancer and other diseases. Both healthy people and cancer patients have immune systems, but if the cancer is too widespread in the body or is progressing too quickly, the body’s immune system is not strong enough to fight it. Cancer peptide vaccines work by enhancing the body’s own immune response against cancer to try and halt its spread.

  • REC name

    North West - Liverpool Central Research Ethics Committee

  • REC reference

    14/NW/1036

  • Date of REC Opinion

    30 Jul 2014

  • REC opinion

    Further Information Favourable Opinion