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The Anti-CTLA-4 Monoclonal Antibody Tremelimumab in Malignant Mesothelioma

Sponsor
Azienda Ospedaliera Universitaria Senese (Other)
Overall Status
Unknown status
CT.gov ID
NCT01655888
Collaborator
MedImmune LLC (Industry)
29
Enrollment
1
Location
1
Arm
30
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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
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 Design

Study Type:
Interventional
Anticipated Enrollment :
29 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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 MESOT-TREM-2012
Study Start Date :
Jul 1, 2012
Anticipated Primary Completion Date :
Jan 1, 2014
Anticipated Study Completion Date :
Jan 1, 2015

Arms and Interventions

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 Names:
  • CP-675,206

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To determine the objective response [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) [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 [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical Oncology and Immunotherapy Unit, University Hospital of Siena Siena Italy 53100

    Sponsors and Collaborators

    • Azienda Ospedaliera Universitaria Senese
    • MedImmune LLC

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michele Maio, Head of Medical Oncology and Immunotherapy Unit, Azienda Ospedaliera Universitaria Senese
    ClinicalTrials.gov Identifier:
    NCT01655888
    Other Study ID Numbers:
    • MESOT-TREM-2012
    • 2012-002762-12
    First Posted:
    Aug 2, 2012
    Last Update Posted:
    Aug 2, 2012
    Last Verified:
    Jul 1, 2012
    Keywords provided by Michele Maio, Head of Medical Oncology and Immunotherapy Unit, Azienda Ospedaliera Universitaria Senese
    Tremelimumab
    anti-CTLA-4 monoclonal antibody
    malignant mesothelioma
    Additional relevant MeSH terms:
    Mesothelioma
    Mesothelioma, Malignant
    Lung Neoplasms
    Tremelimumab

    Study Results

    No Results Posted as of Aug 2, 2012