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

Study identifier:D4880C00003

ClinicalTrials.gov identifier:NCT01843374

EudraCT identifier:2012-003524-21

CTIS identifier:N/A

Recruitment Complete

Official Title

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

Medical condition

Unresectable Pleural or Peritoneal Malignant Mesothelioma

Phase

Phase 2

Healthy volunteers

Study drug

Tremelimumab, Placebo

Sex

All

Actual Enrollment

571

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 17 May 2013

Primary Completion Date: 24 Jan 2016

Estimated Study Completion Date: 31 Dec 2024

Study design

Allocation: Randomized
Endpoint Classification: Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2024 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

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.
12. 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 erythematosus or
granulomatosis with polyangiitis;
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.

No locations available

Arms	Assigned Interventions
Experimental: Tremelimumab Tremelimumab	Drug: Tremelimumab Tremelimumab is to be administered as an IV solution, followed by observation.
Placebo Comparator: Placebo Placebo	Drug: Placebo Placebo is to be administered as an IV solution, followed by observation.

Documents available

FINAL Redacted PROTOCOL_ 03Jan2017
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]