Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects with Unresectable Malignant Mesothelioma - Tremelimumab

Exclusion Criteria

• 1. Subjects who failed more than 2 prior systemic treatment
• regimens for advanced malignant mesothelioma;
• 2. Received any prior mAb against CTLA-4, programmed cell
• death 1 (PD1) or programmed cell death 1 ligand 1 (PD-L1);
• 3. History of chronic inflammatory or autoimmune disease with
• symptomatic disease within the last 3 years prior to
• randomization.
• 4. Active, untreated central nervous system (CNS) metastasis
• 5. Any serious uncontrolled medical disorder or active infection
• that would impair the subject’s ability to receive investigational
• product;
• 6. History of other malignancy unless the subject has been
• disease-free for at least 3 years;
• 7. Pregnant or breast feeding at time of consent;
• 8. Any condition that would prohibit the understanding or
• rendering of information and consent and compliance with the
• requirements of this protocol;
• 9. Active or history of diverticulitis;
• 10. Active or history of inflammatory bowel disease, irritable
• bowel disease, celiac disease or other serious
• gastrointestinal chronic conditions associated with diarrhea.
• Active or history of systemic lupus erythematosus or
• granulomatosis with polyangiitis;
• 11. History of sarcoidosis syndrome;
• 12. Currently receiving systemic corticosteroids or other
• immunosuppressive medications or has a
• medical condition that requires the chronic use of
• corticosteroids.
• 13. Subjects should not be vaccinated with live attenuated
• vaccines within one month prior to starting tremelimumab
• treatment;
• 14. The last dose of prior chemotherapy or radiation therapy was
• received less than 2 weeks prior to randomization;
• 15. Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous
• anticancer therapy with the exception of vitiligo and alopecia;
• 16. Any condition that, in the opinion of the investigator, would
• interfere with evaluation of the investigational product or
• interpretation of subject safety or study results;
• 17. Concurrent enrollment in another clinical study or receipt of
• an investigational product within the last 4 weeks
• 18. Employees of the study site directly involved with the conduct
• of the study, or immediate family members of any such
• individuals;
• 19. Subjects with a history of hypersensitivity to compounds of
• similar biologic composition to tremelimumab or any
• constituent of the product.