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

Sponsor
University of Leicester
Study ID
NCT03654833
Phase
PHASE2
Status
Unknown

Conditions

  • Mesothelioma, Malignant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jan 28, 2019
Status verified
Jan 2023
Primary completion
Oct 31, 2023
Completion
Oct 31, 2023

Study Design

Enrollment
186 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MiST1 Rucaparib
    BRCA1/BAP1 negative mesothelioma; 600mg twice daily (BID) every 28 days.
  • Experimental: MiST2 Abemaciclib
    p16INK4A negative mesothelioma; 200mg orally twice daily every 28 days.
  • Experimental: MiST3 Pembrolizumab & Bemcentinib
    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.
  • Experimental: MiST4 Atezolizumab & Bevacizumab
    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.
  • Experimental: MiST 5 Dostarlimab and Niraparib
    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.

Primary Outcome Measure

Disease control rate (DCR) at 12 weeks assessed by modified RECIST 1.1, in patients with relapsed mesothelioma. [ Time Frame: 12 weeks ]

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