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The Anti-CTLA-4 Monoclonal Antibody Tremelimumab 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: NCT01655888
Recruitment Status : Unknown
Verified July 2012 by Michele Maio, Azienda Ospedaliera Universitaria Senese.
Recruitment status was:  Recruiting
First Posted : August 2, 2012
Last Update Posted : August 2, 2012
MedImmune LLC
Information provided by (Responsible Party):
Michele Maio, Azienda Ospedaliera Universitaria Senese

Brief Summary:

RATIONAL: Preliminary results fron the Study MESOT-TREM-2012 indicate a promising activity of tremelimumab in malignant mesothelioma (MM) patients.

PURPOSE: The proposed study MESOT-TREM-2012 aims to explore the efficacy of a more intensive schedule of treatment with tremelimumab in 29 MM patients. Subjects will receive investigational product every 4 weeks (wks) for 6 doses, followed by doses every 12 wks until confirmed disease progression.

Condition or disease Intervention/treatment Phase
Malignant Mesothelioma Drug: Tremelimumab Phase 2

Detailed Description:

Primary endpoint:

1) To assess the rate of objective clinical complete response (CR) or partial response (PR)

Secondary endpoints:

  1. To define toxicity profile according to NCI CT-CAE V. 3
  2. To assess the overall survival (OS)
  3. To estimate disease control rate (DCR) (proportion of patients with best response of CR+PR+SD) according to the modified Recist criteria
  4. To assess the progression-free survival in treated patients according to modified Recist criteria
  5. To evaluate qualitative and quantitative changes in cellular and humoral immune responses

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2012
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: single arm with Tremelimumab
Tremelimumab: 10mg/Kg ev day 1 every 4 weeks for 6 doses in induction phase, then every 12 weeks in maintenance phase until disease progression of severe toxicity
Drug: Tremelimumab
Tremelimumab is administered as endovenous infusion
Other Name: CP-675,206

Primary Outcome Measures :
  1. To determine the objective response [ Time Frame: Weeks 24 ]
    The objective response is defined as a confirmed complete response (CR), or partial response (PR) according to the modified RECIST Criteria for pleural mesothelioma and the immune-related (ir) Response Criteria

Secondary Outcome Measures :
  1. Disease control rate (DCR) [ Time Frame: 1 year ]
    DCR is the proportion of treated subjects that achieved confirmed CR or PR or stable disease (SD) The DCR is assessed using the modified RECIST Criteria for pleural mesothelioma umor assessment and the the immune-related response criteria

  2. Safety [ Time Frame: 3 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 physycal examination findings are also included.

  3. Progression free survival [ Time Frame: 1 years ]
    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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed MM
  • Have received only one prior systemic chemotherapy platinum-based regimen for advanced MM
  • Measurable disease, defined at least 1 unidimensionally measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan (modified RECIST criteria)
  • 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
  • Platelet count > 75000/mm3
  • Absolute granulocyte count > 1000/mm3
  • Hemoglobin > 9 g/dL
  • Bilirubin total < 1.5 x ULN (Upper limited normal), except patients with documented Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dl
  • AST and ALT < 2.5 x ULN ( < 5 x ULN if documented liver metastasis are present)
  • Creatinine level < 2mg/dl or calculated creatinine clearance > 60 mL/min as determined by the Cockcroft Gault equation.
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • 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
  • Prior treatment with tremelimumab or other anti-CTLA-4 antibody or anti-PD1, anti-PDL-1 agents
  • Clinically relevant cardiovascular disease
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01655888

Contact: Michele Maio, MD +39-0577586335
Contact: Luana Calabrò, MD +39-0577586116

Medical Oncology and Immunotherapy Unit, University Hospital of Siena Recruiting
Siena, Italy, 53100
Contact: Michele Maio, MD    +39-0577586335   
Contact: Luana Calabrò, MD    +39-0577586116   
Principal Investigator: Michele Maio, MD         
Sub-Investigator: Luana Calabrò, MD         
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Senese
MedImmune LLC
Principal Investigator: Michele Maio, MD Medical Oncology and Immunotherapy Unit, University Hospital of Siena, Italy
Principal Investigator: Luana Calabrò, MD Medical Oncology and Immunotherapy, University Hospital of Siena, Italy

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Michele Maio, Head of Medical Oncology and Immunotherapy Unit, Azienda Ospedaliera Universitaria Senese Identifier: NCT01655888     History of Changes
Other Study ID Numbers: MESOT-TREM-2012
2012-002762-12 ( EudraCT Number )
First Posted: August 2, 2012    Key Record Dates
Last Update Posted: August 2, 2012
Last Verified: July 2012

Keywords provided by Michele Maio, Azienda Ospedaliera Universitaria Senese:
anti-CTLA-4 monoclonal antibody
malignant mesothelioma

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents