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



Status:Active, not recruiting
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:3/29/2019
Start Date:May 17, 2013
End Date:December 31, 2019

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A Phase 2b, 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 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.

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.

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 564
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:

1. Histologically and/or cytologically confirmed pleural or peritoneal malignant
mesothelioma;

2. Disease not amenable to curative surgery;

3. Age 18 and over at the time of consent;

4. ECOG Performance status 0-1;

5. 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.

6. 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, 7. Measurable diseaseby modified
RECIST for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma; 8. Adequate
bone marrow, hepatic, and renal function determined within 14 days prior to randomization
defined as: 9. Negative screening test results for human immunodeficiency virus (HIV),
hepatitis A, B and C. 10. 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; 11. 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; cessation of contraception after this point should be discussed
with a responsible physician. 2. Nonsterilized males who are sexually active with a female
partner of childbearing potential must use a highly effective method of contraception from
Days 1 through 90 post last dose. In addition, they must refrain from sperm donation for 90
days after the final dose of investigational product.

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 erythematosis or Wegener's granulomatosis;

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.
We found this trial at
22
sites
2375
mi
from 91732
Philadelphia, PA
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8190
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from 91732
Adelaide,
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2053
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from 91732
Augusta, GA
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2301
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Baltimore, MD
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2044
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from 91732
Canton, OH
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1729
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Chicago, IL
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1225
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Dallas, TX
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2202
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from 91732
Durham, NC
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1357
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Houston, TX
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99
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from 91732
La Jolla, CA
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13
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Los Angeles, CA
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1511
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Minneapolis, MN
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2486
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from 91732
New Haven, CT
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2435
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from 91732
New York, NY
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2435
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from 91732
New York, NY
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2345
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from 91732
Newark, DE
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1618
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from 91732
Peoria, IL
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2245
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from 91732
Rochester, NY
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355
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from 91732
San Francisco, CA
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26
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from 91732
Santa Monica, CA
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352
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from 91732
Scottsdale, AZ
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2136
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from 91732
Tampa, FL
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