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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01843374




Registration number
NCT01843374
Ethics application status
Date submitted
22/04/2013
Date registered
30/04/2013

Titles & IDs
Public title
Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma
Scientific 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
Secondary ID [1] 0 0
2012-003524-21
Secondary ID [2] 0 0
D4880C00003
Universal Trial Number (UTN)
Trial acronym
Tremelimumab
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unresectable Pleural or Peritoneal Malignant Mesothelioma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tremelimumab
Treatment: Drugs - Placebo

Experimental: Tremelimumab - Tremelimumab

Placebo comparator: Placebo - Placebo


Treatment: Drugs: Tremelimumab
Tremelimumab is to be administered as an IV solution, followed by observation.

Treatment: Drugs: Placebo
Placebo is to be administered as an IV solution, followed by observation.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
3 years.
Secondary outcome [1] 0 0
OS Rate at 18 Months by Treatment Arm
Timepoint [1] 0 0
18 months
Secondary outcome [2] 0 0
Progression-free Survival by Treatment Arm
Timepoint [2] 0 0
Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.
Secondary outcome [3] 0 0
Overall Response Rate by Treatment Arm
Timepoint [3] 0 0
Time from randomization to best response to treatment, assessed up to 3 years.
Secondary outcome [4] 0 0
Duration of Response by Treatment Arm
Timepoint [4] 0 0
Duration of response from the first documentation of objcetive response (confirmed CR or PR) to the first documented disease progression, assessed up to 14 weeks after the initial response.
Secondary outcome [5] 0 0
Disease Control Rate by Treatment Arm
Timepoint [5] 0 0
Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.
Secondary outcome [6] 0 0
Durable Disease Control Rate by Treatment Arm
Timepoint [6] 0 0
Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.
Secondary outcome [7] 0 0
Number of Participants Reporting Any Adverse Event
Timepoint [7] 0 0
Day 1- 90 days post dose
Secondary outcome [8] 0 0
Number of Participants Reporting Any Serious Adverse Events
Timepoint [8] 0 0
Day 1 to 90 days post dose
Secondary outcome [9] 0 0
Number of Participants With Positive Anti-drug Antibodies
Timepoint [9] 0 0
Week 5

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/05/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
24/04/2025
Actual
Sample size
Target
Accrual to date
Final
571
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Auchenflower
Recruitment hospital [3] 0 0
Research Site - Box Hill
Recruitment hospital [4] 0 0
Research Site - Chermside
Recruitment hospital [5] 0 0
Research Site - East Bentleigh
Recruitment hospital [6] 0 0
Research Site - Gosford
Recruitment hospital [7] 0 0
Research Site - Heidelberg
Recruitment hospital [8] 0 0
Research Site - Nedlands
Recruitment hospital [9] 0 0
Research Site - Saint Leonards
Recruitment hospital [10] 0 0
Research Site - Waratah
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
4032 - Chermside
Recruitment postcode(s) [5] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [6] 0 0
2250 - Gosford
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment postcode(s) [9] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [10] 0 0
2298 - Waratah
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Delaware
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
Belgium
State/province [15] 0 0
Edegem
Country [16] 0 0
Belgium
State/province [16] 0 0
Gent
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Denmark
State/province [20] 0 0
Copenhagen
Country [21] 0 0
France
State/province [21] 0 0
Caen Cedex
Country [22] 0 0
France
State/province [22] 0 0
Le Mans Cedex
Country [23] 0 0
France
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Lille Cedex
Country [24] 0 0
France
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Nice
Country [25] 0 0
France
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Rennes Cedex 9
Country [26] 0 0
France
State/province [26] 0 0
Toulouse
Country [27] 0 0
France
State/province [27] 0 0
Villejuif Cedex
Country [28] 0 0
Germany
State/province [28] 0 0
Berlin
Country [29] 0 0
Germany
State/province [29] 0 0
Esslingen a.N.
Country [30] 0 0
Germany
State/province [30] 0 0
Freiburg
Country [31] 0 0
Germany
State/province [31] 0 0
Gauting
Country [32] 0 0
Germany
State/province [32] 0 0
Grosshansdorf
Country [33] 0 0
Germany
State/province [33] 0 0
Hamburg
Country [34] 0 0
Germany
State/province [34] 0 0
Hemer
Country [35] 0 0
Germany
State/province [35] 0 0
Karlsruhe
Country [36] 0 0
Germany
State/province [36] 0 0
Lubeck
Country [37] 0 0
Germany
State/province [37] 0 0
Löwenstein
Country [38] 0 0
Hungary
State/province [38] 0 0
Gyöngyös - Mátraháza
Country [39] 0 0
Hungary
State/province [39] 0 0
Törökbálint
Country [40] 0 0
Israel
State/province [40] 0 0
Beer Sheva
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Italy
State/province [41] 0 0
Alessandria
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Italy
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Aviano
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Italy
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Bergamo
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Italy
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Bologna
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Italy
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Candiolo
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Italy
State/province [46] 0 0
Genova
Country [47] 0 0
Italy
State/province [47] 0 0
Meldola
Country [48] 0 0
Italy
State/province [48] 0 0
Milano
Country [49] 0 0
Italy
State/province [49] 0 0
Orbassano
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Italy
State/province [50] 0 0
Padova
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Italy
State/province [51] 0 0
Rozzano
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Italy
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Siena
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Korea, Republic of
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Jeonnam
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Korea, Republic of
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Seoul
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Netherlands
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Breda
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Netherlands
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Eindhoven
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Netherlands
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Rotterdam
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Poland
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Gdansk
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Poland
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Poznan
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Poland
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Szczecin
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Poland
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Warszawa
Country [62] 0 0
Romania
State/province [62] 0 0
Craiova
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Moscow
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Nizhny Novgorod
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Saint-Petersburg
Country [66] 0 0
South Africa
State/province [66] 0 0
Kraaifontein
Country [67] 0 0
South Africa
State/province [67] 0 0
Pretoria
Country [68] 0 0
Spain
State/province [68] 0 0
Barcelona
Country [69] 0 0
Spain
State/province [69] 0 0
Madrid
Country [70] 0 0
Spain
State/province [70] 0 0
Sabadell (Barcelona)
Country [71] 0 0
Spain
State/province [71] 0 0
San Sebastian
Country [72] 0 0
Spain
State/province [72] 0 0
Sevilla
Country [73] 0 0
Sweden
State/province [73] 0 0
Linkoping
Country [74] 0 0
Sweden
State/province [74] 0 0
Lund
Country [75] 0 0
Sweden
State/province [75] 0 0
Umea
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Leeds
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Leicester
Country [78] 0 0
United Kingdom
State/province [78] 0 0
London
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Maidstone
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United Kingdom
State/province [80] 0 0
Manchester
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United Kingdom
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Plymouth
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Southampton
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MedImmune LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01843374