PARCT (EORTC 1652-CLTF)

  • Research type

    Research Study

  • Full title

    Phase II trial of atezolizumab (anti-PD-L1) in the treatment of stage IIb-IV mycosis fungoides/sezary syndrome patients relapsed/refractory after a previous systemic treatment (PARCT)

  • IRAS ID

    248771

  • Contact name

    Julia Scarisbrick

  • Contact email

    Julia.Scarisbrick@uhb.nhs.uk

  • Sponsor organisation

    European Organisation for Research and Treatment of Cancer (EORTC)

  • Eudract number

    2017-003680-35

  • Clinicaltrials.gov Identifier

    NCT03357224

  • Duration of Study in the UK

    3 years, 6 months, 30 days

  • Research summary

    This study is for adults who have Mycosis fungoides or Sézary syndrome who have progressed after initial therapy or have failed to respond to previous therapy.

    Since this therapy is usually only effective for short period of time, the purpose of this study is to find out if giving a new immunotherapy treatment called atezolizumab (Tecentriq) improves the response rate and makes it last longer (Overall Response Rate). The safety of atezolizumab in this study population will also be assessed.

    Immunotherapy treatment has shown promising results in other clinical trials and may be effective in controlling this type of cancer. There is no proof of this yet, which is why the study is being done.

    Atezolizumab is already used to treat other types of cancer. The information from this study will help doctors learn more about atezolizumab as a treatment for Mycosis fungoides or Sézary syndrome.

    The study will compare the effects of atezolizumab using clinical examinations, regular scans and blood tests.

    The study has a translational research component where tumour and blood samples will also be analysed to understand the effects of the drug.

    This study will take place in NHS sites in the UK as part of a wider international study. The study is sponsored and coordinated by the EORTC (European Organisation for Research and Treatment of Cancer), a non-profit organisation based in Brussels.

  • REC name

    East of England - Cambridge East Research Ethics Committee

  • REC reference

    18/EE/0392

  • Date of REC Opinion

    31 Jan 2019

  • REC opinion

    Further Information Favourable Opinion