NCT03654833 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2026-08-17

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Disease Control Rate (DCR) at 12 Weeks Assessed by Modified RECIST 1.1, in Patients With Relapsed Mesothelioma.

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outcome · POSTED

Disease Control Rate (DCR) at 24 Weeks Assessed by Modified RECIST 1.1, in Patients With Relapsed Mesothelioma.

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outcome · POSTED

Objective Response Rate (ORR) at 24 Weeks Assessed by Modified RECIST 1.1, in Patients With Relapsed Mesothelioma.

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
BRCA1/BAP1 negative mesothelioma; 600mg twice daily (BID) every 28 days.
intervention Names
Drug: Rucaparib
label
MiST1 Rucaparib
type
EXPERIMENTAL
description
p16INK4A negative mesothelioma; 200mg orally twice daily every 28 days.
intervention Names
Drug: Abemaciclib
label
MiST2 Abemaciclib
type
EXPERIMENTAL
description
No specific biomarker requirement: Pembrolizumab 200mg IV infusion on Day 1 only: Bemcentinib loading dose of 400mg on days 1-3, on day 4 on-wards 200mg daily every 21-days.
intervention Names
Drug: pembrolizumab & bemcentinib
label
MiST3 Pembrolizumab & Bemcentinib
type
EXPERIMENTAL
description
PDL1 expression positive mesothelioma: Atezolizumab 1200 milligrams via intravenous nfusion; Bevacizumab 15 milligrams per kilogram via IV infusion both on Days 1 every 21-days.
intervention Names
Drug: Atezolizumab & Bevacizumab
label
MiST4 Atezolizumab & Bevacizumab
type
EXPERIMENTAL
description
Platinum sensitive mesothelioma: Niraparib 200-300mg daily every 21 days; Dostarlimab 500mg on day 1 of each 21 day cycle for 4 cycles, then 1000mg on day 1 of each 42 day cycle.
intervention Names
Drug: Dostarlimab and Niraparib
label
MiST 5 Dostarlimab and Niraparib
type
EXPERIMENTAL

interventions

arm Group Labels
MiST1 Rucaparib
description
PARP inhibitor
name
Rucaparib
other Names
CO-338
type
DRUG
arm Group Labels
MiST2 Abemaciclib
description
CDK4/6 inhibitor
name
Abemaciclib
other Names
LY2835219
type
DRUG
arm Group Labels
MiST3 Pembrolizumab & Bemcentinib
description
PD1 checkpoint inhibitor, AXL inhibitor
name
pembrolizumab & bemcentinib
other Names
Keytruda; BGB324
type
DRUG
arm Group Labels
MiST4 Atezolizumab & Bevacizumab
description
PDL1 checkpoint inhibitor, VEGF inhibitor
name
Atezolizumab & Bevacizumab
other Names
MPDL3280A; Avastin
type
DRUG
arm Group Labels
MiST 5 Dostarlimab and Niraparib
description
IG Antibody, PARP Inhibitor
name
Dostarlimab and Niraparib
other Names
Zejula
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 186
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
This will be assessed using CT scan evidence according to modified RECIST 1.1 criteria reporting. Scans will be undertaken every 6 weeks. Analysis will be timed from study entry using the baseline CT scan results until completion of treatment cycles, confirmed disease progression or death-whichever comes first. Complete response (CR): disappearance of all target and non-target lesions with no evidence of tumour elsewhere Partial response (PR): reduction of at least 30% in the sum of all measurements with no evidence of significant disease progression in non-target lesions or new lesions Progressive disease (PD): 1: increase of at least 20% in the sum of all measurements compared with the previous best response, 2: appearance of one or more significant (overall 20% increase in tumour diameters) new lesions, 3: significant increase in target lesions Stable disease (SD): neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD
measure
Disease Control Rate (DCR) at 12 Weeks Assessed by Modified RECIST 1.1, in Patients With Relapsed Mesothelioma.
time Frame
12 weeks

secondary Outcomes

description
This will be assessed using CT scan evidence according to modified RECIST 1.1 criteria reporting. Scans will be undertaken every 6 weeks. Analysis will be timed from study entry using the baseline CT scan results until completion of treatment cycles, confirmed disease progression or death - whichever comes first. Complete response (CR): disappearance of all target and non-target lesions with no evidence of tumour elsewhere Partial response (PR): reduction of at least 30% in the sum of all measurements with no evidence of significant disease progression in non-target lesions or new lesions Progressive disease (PD): 1: increase of at least 20% in the sum of all measurements compared with the previous best response, 2: appearance of one or more significant (overall 20% increase in tumour diameters) new lesions, 3: significant increase in target lesions Stable disease (SD): neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD
measure
Disease Control Rate (DCR) at 24 Weeks Assessed by Modified RECIST 1.1, in Patients With Relapsed Mesothelioma.
time Frame
24 weeks
description
This will be assessed using CT scan evidence according to modified RECIST 1.1 criteria reporting. Scans will be undertaken every 6 weeks. Analysis will be timed from study entry using the baseline CT scan results until completion of treatment cycles, confirmed disease progression or death - whichever comes first. Complete response (CR): disappearance of all target and non-target lesions with no evidence of tumour elsewhere Partial response (PR): reduction of at least 30% in the sum of all measurements with no evidence of significant disease progression in non-target lesions or new lesions Progressive disease (PD): 1: increase of at least 20% in the sum of all measurements compared with the previous best response, 2: appearance of one or more significant (overall 20% increase in tumour diameters) new lesions, 3: significant increase in target lesions Stable disease (SD): neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD
measure
Objective Response Rate (ORR) at 24 Weeks Assessed by Modified RECIST 1.1, in Patients With Relapsed Mesothelioma.
time Frame
24 weeks

Full study description

brief 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.

Source references

references

citation
Fennell DA, King A, Mohammed S, Greystoke A, Anthony S, Poile C, Nusrat N, Scotland M, Bhundia V, Branson A, Brookes C, Darlison L, Dawson AG, Gaba A, Hutka M, Morgan B, Bajaj A, Richards C, Wells-Jordan P, Thomas A; MiST2 study group. Abemaciclib in patients with p16ink4A-deficient mesothelioma (MiST2): a single-arm, open-label, phase 2 trial. Lancet Oncol. 2022 Mar;23(3):374-381. doi: 10.1016/S1470-2045(22)00062-6. Epub 2022 Feb 11.
pmid
35157829
type
DERIVED
citation
Fennell DA, King A, Mohammed S, Branson A, Brookes C, Darlison L, Dawson AG, Gaba A, Hutka M, Morgan B, Nicholson A, Richards C, Wells-Jordan P, Murphy GJ, Thomas A; MiST1 study group. Rucaparib in patients with BAP1-deficient or BRCA1-deficient mesothelioma (MiST1): an open-label, single-arm, phase 2a clinical trial. Lancet Respir Med. 2021 Jun;9(6):593-600. doi: 10.1016/S2213-2600(20)30390-8. Epub 2021 Jan 27.
pmid
33515503
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Independent clinical review pending · Not medical advice