A phase II study to investigate the activity and safety of anti-PD-L1 antibody (Durvalumab) In ADvancEd pretreated malignant pleural Mesothelioma - DIADEM Study - DIADEM

IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI0 sites57 target enrollmentOctober 2, 2018

Overview

No summary available.

Registry

who.int

Start Date

October 2, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI

•1\.Cytological or histological diagnosis of
•unresectable MPM (advanced or inoperable);
•2\.Representative formalin\-fixed paraffin\-embedded (FFPE) tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides for central determination of PD\-L1 expression;
•3\.Aged \= 18 years;
•4\.Performance status 0\-2 (ECOG);
•5\.Measurable disease as defined by Modified RECIST v1\.1 for MPM;
•6\.One previous chemotherapy line for MPM of pemetrexed plus platinum derivative;
•7\.Previous chemotherapy course concluded at least 4 weeks prior to recruitment;
•8\.Signed informed consent;
•9\.Negative pregnancy test. All patients in reproductive age or potential must agree to use effective contraception, as defined by the study protocol for the entire duration of treatment with study drug and for 3 months following its interruption;

•Exclusion Criteria:
•1\.Radiotherapy with curative intent to thoracic wall (concomitant with or prior to chemotherapy);
•2\.Severe concomitant illness;
•3\.History of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain\-Barré syndrome, multiple sclerosis, type I diabetes mellitus, vasculitis, or glomerulonephritis;
•4\.Enrolment in other trials;
•5\.Any other anti\-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent);
•6\.Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis);
•7\.History of primary immunodeficiency;
•8\.HIV, TB, HBV or HCV infection (HBsAg\+; HCV\-RNA\+);
•9\.History of allogeneic organ transplant;