By incorporating a platform trial protocol design, SELECTmeso will spearhead a next-generation precision medicine trial platform in relapsed mesothelioma for the UK enabling early evaluation of hypothesis-driven targeted therapies. The SELECTmeso Platform trial protocol allows incorporation of a range of identified and yet-to-be-identified candidates as potential treatments for patients with relapsed mesothelioma into the platform. Candidate Specific Trials (CSTs) will be added into the trial via treatment-specific CSTs of this platform trial protocol as appendices. Having one platform trial protocol ensures different candidates are evaluated in the same consistent manner and that opening up new trials for new candidates is more efficient.
SELECTmeso1 is our first Candidate Specific Trial (CST) on the platform. SELECTmeso1 is investigating if a drug called BMS-986504 is effective in shrinking mesothelioma tumours as a targeted treatment for patients with tumours that have specific genetic biomarkers. Biomarkers are molecules that can indicate normal or abnormal processes taking place in the body or tumour, they can indicate how effective certain treatments will be. BMS-986504 has shown to be tolerated and promising signs of activity on patients with MTAP-deficient solid tumours, in a previous mesothelioma trial.
Histological confirmation of malignant mesothelioma (pleural, or non-pleural)
Evidence of disease progression on CT scan
Available archival tissue block for molecular screening or existing molecular screening result via validated NHS diagnostic grade immunohistochemistry-based assays
Previous treatment with at least 1st line licensed systemic anti-cancer therapy. Patients can have received more than one prior line of systemic therapy
Patients with a diagnosis of a second malignancy (except prostate or cervical cancer in remission, patients with a diagnosis of basal cell carcinoma or non-muscle invasive bladder cancer, who can all be included)
New York Heart Association Class II or greater congestive heart failure
Patients requiring long term oxygen therapy
Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
University of Southampton
Lead sponsor
Bristol-Myers Squibb
Collaborator