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.
|First Received Date||August 7, 2018|
|Last Changed Date||January 31, 2019|
|Start Date||January 28, 2019|
|Anticipated Primary Completion Date||July 30, 2021|
|Primary Outcome Measures||
Disease control rate (DCR) at 12 weeks assessed by modified RECIST 1.1, in patients with relapsed mesothelioma. [Time Frame: 12 weeks]
|Secondary Outcome Measures||
Disease control rate (DCR) at 24 weeks assessed by modified RECIST 1.1, in patients with relapsed mesothelioma. [Time Frame: 24 weeks]
Objective response rate (ORR) assessed for 12 months [Time Frame: Up to 12 months (up to 6 months during treatment and 6 months of follow-up)]
Safety assessed according to CTCAE criteria. [Time Frame: 12 months (up to 6 months during treatment and 6 months of follow-up)]
Toxicity assessed according to CTCAE criteria. [Time Frame: 12 months (up to 6 months during treatment and 6 months of follow-up)]
|Study Arms / Comparison Groups||4 / 0|
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 and 4, immune checkpoint, transcriptomic and gut microbiome correlative studies are planned.
|Ages||18 Years - N/A|
|Accepts Healthy Volunteers||No|
Amy King, MSc
Phone: +44 (0)116 229 x7249
INCLUSION CRITERIA FOR PRE-SCREENING
- Histologically confirmed MM with an available biopsy for research purposes
- Male or female patients aged ≥18 years.
- Expected survival of ≥12 weeks or greater
- ECOG PS 0-1
- CT scan chest, abdomen (and pelvis if applicable) confirming disease progression.
- Patients must have received at least one prior line of therapy to include a platinum doublet first-line chemotherapy (within or outside of another clinical trial)
- Willing to consent for molecular screening of archived tumour block (PIS1 & CF1)
EXCLUSION CRITERIA FOR PRE-SCREENING
- Patients with a diagnosis of a second malignancy except prostate or cervical cancer in remission, patients with a diagnosis of basal cell carcinoma of the skin or superficial bladder cancer.
- Uncontrolled CNS disease. Asymptomatic brain metastases are allowed if previously treated with radiotherapy >28 days prior to starting the investigational agent.
- New York Heart Association Class II or greater congestive heart failure.
- Patients with severe hepatic insufficiency or severe renal impairment.
- Patients requiring long term oxygen therapy.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants 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.
Each individual MiST drug protocol contains the eligibility criteria specific to the treatment allocated to the patient.
|Sponsor||University of Leicester|
|Verification Date||June 2018|