A Clinical Study With Tremelimumab as Monotherapy in Malignant Mesothelioma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Azienda Ospedaliera Universitaria Senese.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Michele Maio, Azienda Ospedaliera Universitaria Senese
ClinicalTrials.gov Identifier:
NCT01649024
First received: July 18, 2012
Last updated: July 20, 2012
Last verified: July 2012
  Purpose

The study is designed to define the immunologic and clinical activity of Tremelimumab in patients with advanced mesothelioma.


Condition Intervention Phase
Malignant Mesothelioma
Drug: Tremelimumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera Universitaria Senese:

Primary Outcome Measures:
  • Objective tumor response by modified Response Evaluation Criteria in Solid Tumor (RECIST) [ Time Frame: Weeks 24 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Disease control rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 29
Study Start Date: May 2009
Estimated Study Completion Date: June 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single arm of Tremelimumab
Tremelimumab is administered at 15 mg/kg on day 1 every 12 weeks for 4 doses
Drug: Tremelimumab
Given IV
Other Name: CP-675,206

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649024

Locations
Italy
Medical Oncology and Immunotherapy Unit, University Hospital of Siena
Siena, Italy, 53100
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Senese
Investigators
Principal Investigator: Michele Maio, MD Medical Oncology and Immunotherapy Unit, University Hospital of Siena
  More Information

No publications provided

Responsible Party: Michele Maio, Head of Medical Oncology and Immunotherapy, University Hospital of Siena, Azienda Ospedaliera Universitaria Senese
ClinicalTrials.gov Identifier: NCT01649024     History of Changes
Other Study ID Numbers: MESOT-TREM-2008, 2008-005171-95
Study First Received: July 18, 2012
Last Updated: July 20, 2012
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Azienda Ospedaliera Universitaria Senese:
Tremelimumab
Malignant Mesothelioma
anti-CTLA-4 mAb

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014