BO42843 - CWOW IRAS 1003548 - PHASE III STUDY OF ATEZOLIZUMAB

• Research type

  Research Study

• Full title

  A PHASE III, DOUBLE-BLIND, MULTI-CENTRE, RANDOMISED STUDY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) VERSUS PLACEBO AS ADJUVANT THERAPY IN PATIENTS WITH HIGH-RISK MUSCLE-INVASIVE BLADDER CANCER WHO ARE CTDNA POSITIVE FOLLOWING CYSTECTOMY

• IRAS ID

  1003548

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Eudract number

  2020-004418-36

• Clinicaltrials.gov Identifier

  NCT04660344

• Research summary

  Organ confined muscle invasive bladder cancer (MIBC) is potentially curable with surgery (cystectomy). Cure rates are improved if chemotherapy is given beforehand in those patients fit enough to receive it. However, approximately half of patients will relapse subsequently and most of these will die of their cancer. Relapse is usually detected through scans or bladder surveillance (cystoscopy).
  Some patients with a relapsing bladder cancer will have detectable circulating tumour DNA (ctDNA) that is shed into their blood before the cancer can be seen either on scans or at cystoscopy. We do not know if this experimental approach to early detection might allow for better outcomes if we used it to commence salvage drug treatments earlier.
  The purpose of Study BO42843 is to compare the effects of atezolizumab immunotherapy versus placebo on patients with high-risk MIBC who have ctDNA detected in their blood after their cancer was fully removed by surgery. Currently, no therapy is approved for patients with ctDNA in their blood (and the test itself is experimental). Atezolizumab is approved for later stages of the disease where distant metastases have been seen on scans. Its earlier use when the only evidence of relapse is a positive ctDNA blood test is experimental.
  The study surveillance phase will include blood samples for ctDNA testing and surveillance imaging for tumour recurrence starting 6-14 weeks after cystectomy for up to 21 months. Patients will enter the treatment phase of the study at the first blood sample that is ctDNA positive (if this occurs). There are two randomised treatment arms (atezolizumab and placebo) where study drug is given every 4 weeks for 12 months. After this time patients will be followed up until the end of Year 6. Approximately 15 participants will take part in the Treatment Phase of the study in the UK at approximately 11 sites from 275 participants worldwide.
  The study is sponsored by F. Hoffman La Roche.
  v1.0 08Feb2021

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  21/YH/0049

• Date of REC Opinion

  18 Mar 2021

• REC opinion

  Favourable Opinion