A Clinical Study With Tremelimumab as Monotherapy in Malignant Mesothelioma

Malignant Mesothelioma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01649024
• Other study ID #: MESOT-TREM-2008
• Secondary ID: 2008-005171-95
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 18, 2012
• Last updated: July 20, 2012
• Start date: May 2009
• Est. completion date: June 2013

Study information

• Verified date: July 2012
• Source: Azienda Ospedaliera Universitaria Senese
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 29
• Est. completion date: June 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Malignant Mesothelioma
• Mesothelioma

Intervention

Drug:
• Tremelimumab
Given IV

Locations

Country	Name	City	State
Italy	Medical Oncology and Immunotherapy Unit, University Hospital of Siena	Siena

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Senese

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective tumor response by modified Response Evaluation Criteria in Solid Tumor (RECIST)	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	Weeks 24	No
Secondary	Disease control rate	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	1 year	No
Secondary	Progression free survival	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	1 year	No
Secondary	Safety	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.	2 years	Yes