A Phase 2, Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Second- or Third-line Treatment of Subjects with Unresectable Pleural or Peritoneal Malignant Mesothelioma

MedImmune, LLC0 sites180 target enrollmentJuly 1, 2013

Overview

No summary available.

Registry

who.int

Start Date

July 1, 2013

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Subjects must meet all of the following criteria:
•\- Histologically and/or cytologically confirmed pleural or peritoneal malignant mesothelioma. Disease not amenable to curative surgery;
•\- Age 18 and over at the time of consent;
•\- ECOG Performance status 0\-1;
•\- Previous receipt of 1\-2 prior systemic chemotherapies that included first\-line pemetrexed (or anti\-folate)\-based regimen in combination with platinum agent;
•\- Recovered from all toxicities associated with prior treatment
•\- Measurable disease
•\- Adequate bone marrow, hepatic, and renal function
•\- Negative screening test results for human immunodeficiency virus (HIV), hepatitis A, B and C.
•\- Written informed consent and any locally required authorization (eg, HIPAA in the USA, EU Data Privacy Directive authorization in the EU) obtained from the subject/legal representative prior to performing any protocol\-related procedures, including screening evaluations;

•Any of the following would exclude the subject from participation in the study:
•\- Received any prior monoclonal antibody against CTLA\-4, programmed cell death 1 (PD1\) or programmed cell death 1 ligand 1 (PD\-L1\);
•\- History of chronic inflammatory or autoimmune disease;
•\- Active, untreated central nervous system (CNS) metastasis;
•\- 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;
•\- Pregnant or breast feeding at time of consent;
•\- Any condition that would prohibit the understanding or rendering of information and consent and compliance with the requirements of this protocol;
•\- Active or history of diverticulitis. Note that diverticulosis is permitted;
•\- 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;