Międzybłoniak: badanie fazy II leku tremelimumab

Kryteria wyłączenia kto nie może wziąć udziału (17)

1. Subjects who failed more than 2 prior systemic treatment regimens for advanced malignant mesothelioma
2. Received any prior monoclonal antibody 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;
4. Active, untreated central nervous system (CNS) metastasis;
5. History of other malignancy unless the subject has been disease-free for at least 3 years. Non-invasive cancer history (such as carcinoma in situ [CIS] that has been resected) is allowed;
6. Pregnant or breast feeding at time of consent;
7. Any condition that would prohibit the understanding or rendering of information and consent and compliance with the requirements of this protocol;
8. Active or history of diverticulitis. Note that diverticulosis is permitted;
9. Active or history of inflammatory bowel disease (eg, colitis, Crohn's), irritable bowel disease, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea. Active or history of systemic lupus erythematosis or Wegener's granulomatosis;
10. History of sarcoidosis syndrome;
11. Currently receiving systemic corticosteroids or other immunosuppressive medications;
12. Subjects should not be vaccinated with live attenuated vaccines within one month prior to starting tremelimumab treatment;
13. The last dose of prior chemotherapy or radiation therapy (with the exception of palliative radiotherapy) was received less than 2 weeks prior to randomization;
14. Any unresolved toxicity from previous anticancer therapy;
15. 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;
16. Concurrent enrollment in another clinical study or receipt of an investigational product within the last 4 weeks (participation in the survival follow-up period of a study is not an exclusion criterion);
17. Employees of the study site directly involved with the conduct of the study, or immediate family members of any such individuals.