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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

Phase 2
18 Years
Open (Enrolling)
Malignant Mesothelioma

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Trial Information

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

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.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective tumor response by modified Response Evaluation Criteria in Solid Tumor (RECIST)

Outcome Description:

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

Outcome Time Frame:

Weeks 24

Safety Issue:


Principal Investigator

Michele Maio, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical Oncology and Immunotherapy Unit, University Hospital of Siena


Italy: The Italian Medicines Agency

Study ID:




Start Date:

May 2009

Completion Date:

June 2013

Related Keywords:

  • Malignant Mesothelioma
  • Tremelimumab
  • Malignant Mesothelioma
  • anti-CTLA-4 mAb
  • Mesothelioma