RT-IMMUNE

• Research type

  Research Study

• Full title

  A European, multicenter, randomized, open-label, Phase II trial aiming to assess the clinical and biological activity of an anti-PD-L1 (atezolizumab) in operable localised soft tissue sarcomas patients to be treated with radiotherapy

• IRAS ID

  276314

• Contact name

  Shane Zaidi

• Contact email

  shane.zaidi@rmh.nhs.uk

• Sponsor organisation

  Centre Léon Bérard

• Eudract number

  2016-005019-42

• Clinicaltrials.gov Identifier

  NCT03474094

• Clinicaltrials.gov Identifier

  MEDAECPP-2017-12-0009, French Competent Authority; CPP 17/92, French Ethic Committee : CPP Nord-Ouest IV

• Duration of Study in the UK

  2 years, 4 months, 31 days

• Research summary

  Soft tissue sarcoma (STS) is a rare cancer for which the main treatment is surgery preceded or followed by radiotherapy. This primary care is critical to limit the risk of relapses. Unfortunately, the risk of relapse remains high in patients with STS. New therapy strategies are needed and research is ongoing to improve the primary care. Several clinical trials have demonstrated the efficacy of immunotherapies. Immunotherapies target and stimulate the immune system to fight the cancer cells. Among immunotherapies, antibodies, like atezolizumab, have been developed to restore an efficient immune response against cancer cells. However, clinical data on immunotherapies used in patients with STS are rare and heterogonous in terms of efficacy. Clinical investigations on immunotherapies combined to primary care must therefore be conducted further in patients with STS.

  Some research suggested that radiotherapy could provide a favourable immune environment to enhance the efficacy of immunotherapies when combined to primary care.
  This research aims to assess the clinical and biological impact of radiotherapy combined to atezolizumab in patients with localised and operable STS

  About 69 patients will participate to this study among 2 Countries in Europe: United Kingdom and France.
  

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  21/NW/0063

• Date of REC Opinion

  16 Apr 2021

• REC opinion

  Further Information Favourable Opinion