A Clinical Study With Tremelimumab as Monotherapy in Malignant Mesothelioma
NCT ID: NCT01649024
Last Updated: 2012-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
29 participants
INTERVENTIONAL
2009-05-31
2013-06-30
Brief Summary
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Detailed Description
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Clinical studies examining CTLA-4 blockade are providing convincing evidences on the immunobiological effects and on the clinical activity of this new class of immunomodulating therapeutic agents, likely due to their ability to stimulate patients'immune system to more effectively attack tumor cells by blocking a negative regulatory signal.
Tremelimumab is a fully human anti-CTLA-4 monoclonal antibody (mAb), developed as an IgG2 isotype to minimize complement activation and reduce the risk of cytokine storm. As a single agent, Tremelimumab can induce durable tumor regression in 7-10% of patients with advanced melanoma. Tremelimumab has been tested in several clinical trials as single-agent or in combination with other agents in different solid tumors.
The evidences above unveil a strong immunologic potential of treatment with Tremelimumab also in MM patients.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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single arm of Tremelimumab
Tremelimumab is administered at 15 mg/kg on day 1 every 12 weeks for 4 doses
Tremelimumab
Given IV
Interventions
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Tremelimumab
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have received only one prior systemic chemotherapy platinum-based regimen for advanced MM
* Disease not amenable to curative surgery
* No known brain metastasis
* Age 18 and over
* Performance status 0-2
* Life expectancy \> 12 weeks
* Adequate hematologic, hepatic and renal function
* Not pregnant or nursing
* Patient must be willing and able to provide written informed consent, and the trial have to be approved by the institutional review board at each institution
Exclusion Criteria
* Active hepatitis B or C
* Clinically relevant cardiovascular disease, i.e., myocardial infarction or other severe coronary artery diseases within the prior 6 months, cardiac arrythmia requiring medication, uncontrolled hypertension, overt cardiac failure or not compensated chronic heart disease in NYHA class II or more
* History of psychiatric disabilities, potentially interfering with the capability of giving adequate informed consent
* Uncontrolled active infections
* Other concurrent chemotherapy, immunotherapy, radiotherapy or investigational agents
* History of other malignancies except for adequately treated basal cell carcinoma or squamous cell skin cancer or carcinoma of cervix, unless the patient has been disease-free for at least 5 years
18 Years
ALL
No
Sponsors
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Azienda Ospedaliera Universitaria Senese
OTHER
Responsible Party
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Michele Maio
Head of Medical Oncology and Immunotherapy, University Hospital of Siena
Principal Investigators
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Michele Maio, MD
Role: PRINCIPAL_INVESTIGATOR
Medical Oncology and Immunotherapy Unit, University Hospital of Siena
Locations
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Medical Oncology and Immunotherapy Unit, University Hospital of Siena
Siena, , Italy
Countries
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References
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Calabro L, Morra A, Fonsatti E, Cutaia O, Amato G, Giannarelli D, Di Giacomo AM, Danielli R, Altomonte M, Mutti L, Maio M. Tremelimumab for patients with chemotherapy-resistant advanced malignant mesothelioma: an open-label, single-arm, phase 2 trial. Lancet Oncol. 2013 Oct;14(11):1104-1111. doi: 10.1016/S1470-2045(13)70381-4. Epub 2013 Sep 11.
Other Identifiers
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2008-005171-95
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MESOT-TREM-2008
Identifier Type: -
Identifier Source: org_study_id