NCT03654833

Mesothelioma Stratified Therapy (MiST) : A Multi-drug Phase II Trial in Malignant Mesothelioma

Mesothelioma Stratified Therapy (MiST): A Stratified Multi-arm Phase IIa Clinical Trial to Enable Accelerated Evaluation of Targeted Therapies for Relapsed Malignant Mesothelioma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: University of Leicester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

MiST is a British Lung Foundation funded, University of Leicester Study, a multi-arm stratified therapy based clinical trial for patients with relapsed mesothelioma. The goal of MiST is to enable acceleration of novel, effective personalised therapy as a basis for improving survival outcomes for patients with mesothelioma.

Detailed description

Stage 1 - molecular pre-screening: The MiST Master protocol describes the identification of patients, biomarker testing and analysis. Patients with relapsed mesothelioma will be offered to consent for molecular panel testing of their diagnostic tumour block for predictive biomarkers. The results of this assessment will be used to classify patients into one of several possible molecularly defined treatment arms. Patients will therefore be offered a specific study treatment determined by their molecular profile. Patients, who exhibit positive testing in more than one biomarker, will potentially be eligible to subsequently be treated on a different treatment protocol upon disease progression or treatment failure. Stage 2 - Treatment: The MiST treatment protocol will be specific to the treatment allocated to the patient - based on the results of their biomarker testing in stage 1. Specific agent(s) will be detailed separately in each of the separate treatment protocols. Stage 3 - Molecular Profiling : In order to understand the genomic basis of drug response in the MiST trial, archival tumour tissue from all patients enrolled will be interrogated using molecular inversion probe- based microarray analysis of the somatic copy number aberrations. Optional re-biopsy of patients who progress on treatment, followed confirmed radiological response, will be offered, to investigate genomic interrogation of tumours at the time of acquired resistance. For arms 3, 4 and 5 immune checkpoint, transcriptomic and gut microbiome correlative studies are planned.

Conditions

• Mesothelioma, Malignant

Interventions

Type	Name	Description
DRUG	Rucaparib	PARP inhibitor
DRUG	Abemaciclib	CDK4/6 inhibitor
DRUG	pembrolizumab & bemcentinib	PD1 checkpoint inhibitor, AXL inhibitor
DRUG	Atezolizumab & Bevacizumab	PDL1 checkpoint inhibitor, VEGF inhibitor
DRUG	Dostarlimab and Niraparib	IG Antibody, PARP Inhibitor

Timeline

• Start date: 2019-01-28
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2018-08-31
• Last updated: 2023-03-14

Locations

1 site across 1 country: United Kingdom