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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

Phase 2
18 Years
Open (Enrolling)
Unresectable Pleural or Peritoneal Malignant Mesothelioma

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Trial Information

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

This is a Phase 2, 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.

Randomization will be stratified by EORTC status (low-risk vs high-risk), line of therapy
(second vs third), and anatomical site (pleural vs peritoneal). This study plans to use the
EORTC to stratify subjects into high or low risk groups in order to ensure balanced
randomization to the different treatment groups. For subjects in whom pemetrexed was
contraindicated or not tolerated or not an approved therapy (eg, peritoneal mesothelioma),
prior therapy with a first-line platinum-based regimen is required. Approximately 180
subjects will be enrolled at study centers in multiple countries.

The study consists of a screening period, a treatment period, and a 90-day follow-up period.

Inclusion Criteria

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;

- 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;

- Females of childbearing potential who are sexually active with a nonsterilized male
partner must use a highly effective method of contraception for 28 days prior to the
first dose of investigational product, and must agree to continue using such
precautions for 6 months after the final dose of investigational product;

- Nonsterilized males who are sexually active with a female partner of childbearing
potential must use a highly effective method of contraception from Day 1 through 90
post last dose.

Exclusion criteria:

- 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;

- History of sarcoidosis syndrome;

- Currently receiving systemic corticosteroids or other immunosuppressive medications;

- Subjects should not be vaccinated with live attenuated vaccines within one month
prior to starting tremelimumab treatment;

- The last dose of prior chemotherapy or radiation therapy (with the exception of
palliative radiotherapy) was received less than 2 weeks prior to randomization;

- 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;

- 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);

- Employees of the study site directly involved with the conduct of the study, or
immediate family members of any such individuals.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall survival (OS) time by treatment arm

Outcome Description:

The primary analysis of OS will be performed after a number of deaths have occurred among the approximately 180 participants randomized. For participants who are alive at the time of the primary analysis or lost to follow-up, OS will be censored on the last date when participants are known to be alive.

Outcome Time Frame:

Time from randomization until death due to any cause, assessed up to 3 years.

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2013

Completion Date:

July 2015

Related Keywords:

  • Unresectable Pleural or Peritoneal Malignant Mesothelioma
  • tremelimumab
  • pleural, peritoneal
  • malignant mesothelioma
  • CTLA-4
  • Mesothelioma



Research SiteAnaheim, California  
Research SiteBoca Raton, Florida  
Research SiteArlington Heights, Illinois  
Research SiteBattle Kreek, Michigan  
Research SiteAlbany, New York  
Research SiteAkron, Ohio  
Research SiteAbilene, Texas