SELECTmeso

• Research type

  Research Study

• Full title

  Platform: SynthEtic LEthal Cancer Therapy in mesothelioma (SELECTmeso): a molecularly stratified multi-arm phase II platform trial for patients with relapsed malignant mesothelioma Arm1: SELECTmeso1: A phase II trial of brigimadlin (BI 907828) in patients with MTAP loss and wild type p53 relapsed mesothelioma

• IRAS ID

  1008628

• Contact name

  Dean Fennell

• Contact email

  df132@le.ac.uk

• Sponsor organisation

  University Hospital Southampton NHS Foundation Trust

• ISRCTN Number

  ISRCTN15046526

• Research summary

  Mesothelioma is a rare cancer caused by exposure to asbestos typically affecting the lungs, the sac containing the heart and less commonly the lining of abdominal cavity or testis. The prognosis for patients with relapsed mesothelioma is poor and the current treatment options are limited. It is thought that the outcome of the treatment is determined by the underlying genetic make-up of the cancer. For example, cancers with a mutation removing BAP1 have a much better prognosis compared with cancers with a mutation removing MTAP.
  The SELECTmeso trial platform has been developed to gain insight into how beneficial targeting the genetic make-up of the cancer is. It is hoped that the outcome of this platform will justify future randomised trials to compare the effectiveness of targeted agents against standard of care.
  The SELECTmeso trial platform aims to start recruitment in Winter 2024 with its first single arm phase II “SELECTmeso1” trial enrolling 26 patients. Further treatment arms will be added over time for specific targeted therapies.
  Patients will enrol into the trial platform by providing their diagnostic tumour sample which will be analysed in a laboratory to determine the genetic make-up of the cancer. The patient will be assessed for eligibility against the open treatment arms and offered to participate if eligible. Each arm will be looking at how well the treatment controls the disease after 12 weeks and 24 weeks. We will also look at how long the patient is progression free for, the safety of the treatment and how well it is tolerated by the patients.
  Patients enrolling to SELECTmeso1 will received treatment with brigimadlin for 6 months. This will involve taking a tablet once every 3 weeks and attending hospital visits for assessments, scans and blood tests.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  24/SC/0293

• Date of REC Opinion

  1 Nov 2024

• REC opinion

  Further Information Favourable Opinion