CheckpOiNt Blockade For Inhibition of Relapsed Mesothelioma
Status:
Active, not recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
The UK has the highest incidence of mesothelioma. The incidence has risen by 497% since the
late 1970's and is increasing worldwide due to continued mining and use of asbestos. For
patients with mesothelioma who have relapsed after taking pemetrexed and cisplatin, there is
currently no standard treatment, making this an urgent unmet need. Recent trials in this area
have not found an effective treatment that improves overall survival.
Following a debate in the House of Lords, a national survey assessing the research priorities
in mesothelioma found that 'exploiting the potential of immunotherapy' was a top priority.
This trial was designed in response to that survey. It uses the immunotherapy agent nivolumab
which blocks programmed cell death 1 (PD-1) receptor on activated T-cells (a type of white
blood cell forming part of the immune system). Early research has found a dependency of
mesothelioma on the PD-1 checkpoint. By attaching to PD-1, nivolumab blocks its action
(checkpoint inhibition), preventing it from turning off the T-cell, and therefore allowing
the immune system to work. PD-1 checkpoint inhibition has revolutionised the treatment of
melanoma and it is hoped to be as effective in mesothelioma.
This trial is a randomised, double blind placebo controlled trial of patients with
mesothelioma who are second or third relapse following a platinum based chemotherapy
treatment. Patients will be randomised in a 2:1 ratio (nivolumab: placebo).
336 patients will be recruited from 25 UK centres with the last patient having a minimum of 6
months follow up. All patients will be on treatment for 12 months unless they progress or
withdrawal prior to this.
Phase:
Phase 3
Details
Lead Sponsor:
University of Southampton
Collaborators:
Beatson West of Scotland Cancer Centre Bristol-Myers Squibb Queen Mary University of London Queen's University, Belfast University of Leicester University of Sheffield Velindre NHS Trust