Mesothelioma Stratified Therapy (MiST) - Including the following treatment arms: MiST 1 rucaparib MiST 2 abemaciclib MiST 3 pembrolizumab in combination with bemcentinib MiST 4 atezolizumab in combination with bevacizumab

Phase 1

• Conditions: Malignant Mesothelioma (MM) - pleural and peritoneal; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-003353-41-GB
• Lead Sponsor: niversity of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-03
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

Stage 1: Registration Inclusion Criteria:
•Histologically confirmed MM an available biopsy for research
•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)

Stage 2: Treatment
Based on the result of Stage 1 (registration), patients will be enrolled according to the MiST arm eligibility criteria which will be protocol specific.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Stage 1: Registration Exclusion Criteria:
•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 study, or may influence the result of the study, or the participant’s ability to participate in the study.

Stage 2: Treatment
Please refer to the exclusion criteria of the specific treatment protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified