Mesothelioma Stratified Therapy (MiST) : A Multi-drug Phase II Trial in Malignant Mesothelioma (MiST)
Mesothelioma, Malignant
About this trial
This is an interventional treatment trial for Mesothelioma, Malignant focused on measuring Drug: multi-arm, Phase IIa
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.
Sites / Locations
- University Hospitals of Leicester NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
MiST1 Rucaparib
MiST2 Abemaciclib
MiST3 Pembrolizumab & Bemcentinib
MiST4 Atezolizumab & Bevacizumab
MiST 5 Dostarlimab and Niraparib
BRCA1/BAP1 negative mesothelioma; 600mg twice daily (BID) every 28 days.
p16INK4A negative mesothelioma; 200mg orally twice daily every 28 days.
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.
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.
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.