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

• Status: Recruiting
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Leicester
• Collaborators: BerGenBio ASA; British Lung Foundation; Clovis Oncology, Inc.; Eli Lilly and Company; GlaxoSmithKline; Merck Sharp & Dohme Corp.; Roche Pharma AG; The Christie NHS Foundation Trust; University Hospitals, Leicester
• Treatments: Antibodies, Monoclonal; Atezolizumab; Bevacizumab; Niraparib; Pembrolizumab; Rucaparib

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.