Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Ma… (NCT01843374) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma
United States571 participantsStarted 2013-05-17
Plain-language summary
This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo. Approximately 564 subjects will be enrolled at study centers in multiple countries. The study consists of a screening period, a treatment period, a 90-day follow-up period for safety, and a long-term survival follow-up period.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion 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;
✓. Progressed after previous receipt of 1-2 prior systemic treatments for advanced disease that included a first-line pemetrexed (or anti-folate)-based regimen in combination with platinum agent.
✓. Recovered from all toxicities associated with prior treatment, to acceptable baseline status, or a NCI CTCAE Grade of 0 or 1, except for toxicities not considered a safety risk,
✓. Measurable diseaseby modified RECIST for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma;
✓. Adequate bone marrow, hepatic, and renal function determined within 14 days prior to randomization defined as:
Exclusion criteria
✕. Subjects who failed more than 2 prior systemic treatment regimens for advanced malignant mesothelioma;
✕. Received any prior mAb against CTLA-4, programmed cell death 1 (PD1) or programmed cell death 1 ligand 1 (PD-L1);
✕. History of chronic inflammatory or autoimmune disease with symptomatic disease within the last 3 years prior to randomization.
. Active, untreated central nervous system (CNS) metastasis
✕. Any serious uncontrolled medical disorder or active infection that would impair the subject's ability to receive investigational product;
✕. History of other malignancy unless the subject has been disease-free for at least 3 years;
✕. 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;