A Clinical Study With Tremelimumab as Monotherapy in Malignant Mesothelioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01649024
Recruitment Status : Unknown
Verified July 2012 by Michele Maio, Azienda Ospedaliera Universitaria Senese.
Recruitment status was:  Active, not recruiting
First Posted : July 25, 2012
Last Update Posted : July 25, 2012
Information provided by (Responsible Party):
Michele Maio, Azienda Ospedaliera Universitaria Senese

July 18, 2012
July 25, 2012
July 25, 2012
May 2009
June 2012   (Final data collection date for primary outcome measure)
Objective tumor response by modified Response Evaluation Criteria in Solid Tumor (RECIST) [ Time Frame: Weeks 24 ]
The objective tumor response is defined as a confirmed complete response (CR) or partial response (PR) according to the modified RECIST criteria for pleural mesothelioma
Same as current
No Changes Posted
  • Disease control rate [ Time Frame: 1 year ]
    Disease control rate (DCR) is the proportion of treated subjects that achieved confirmed complete response, or partial response, or stable disease. The DCR is assessed using the modified RECIST criteria for pleural mesothelioma
  • Progression free survival [ Time Frame: 1 year ]
    Progression free survival is computed from the first day of study treatment to the day of documented progression according to the modified RECIST criteria for pleural mesothelioma or death, whichever occurs first
  • Safety [ Time Frame: 2 years ]
    The assessment of safety includes serious and non-serious adverse events according to NCI-CTC criteria version 3.0. In addition, laboratory evaluation, abnormal vital signs and physical examination findings are also included.
Same as current
Not Provided
Not Provided
A Clinical Study With Tremelimumab as Monotherapy in Malignant Mesothelioma
A Second-line, Single Arm, Phase II Clinical Study With Tremelimumab, a Fully Human Anti-CTLA-4 Monoclonal Antibody as Monotherapy in Patients With Unresectable Malignant Mesothelioma
The study is designed to define the immunologic and clinical activity of Tremelimumab in patients with advanced mesothelioma.

No effective standard treatment can improve significantly the prognosis of malignant mesothelioma (MM) patients. However, there is evidence that MM patients may benefit from immunotherapeutic agents.

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.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Malignant Mesothelioma
Drug: Tremelimumab
Given IV
Other Name: CP-675,206
Experimental: single arm of Tremelimumab
Tremelimumab is administered at 15 mg/kg on day 1 every 12 weeks for 4 doses
Intervention: Drug: Tremelimumab
Calabrò 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
June 2013
June 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically confirmed malignant mesothelioma (MM)
  • 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:

  • Symptomatic chronic inflammatory or autoimmune disease
  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
2008-005171-95 ( EudraCT Number )
Not Provided
Not Provided
Michele Maio, Azienda Ospedaliera Universitaria Senese
Azienda Ospedaliera Universitaria Senese
Not Provided
Principal Investigator: Michele Maio, MD Medical Oncology and Immunotherapy Unit, University Hospital of Siena
Azienda Ospedaliera Universitaria Senese
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP