A Clinical Study With Tremelimumab as Monotherapy in Malignant Mesothelioma
The study is designed to define the immunologic and clinical activity of Tremelimumab in patients with advanced mesothelioma.
|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|
- 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
- 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.
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||June 2013|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Experimental: single arm of Tremelimumab
Tremelimumab is administered at 15 mg/kg on day 1 every 12 weeks for 4 doses
Other Name: CP-675,206
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.
|Medical Oncology and Immunotherapy Unit, University Hospital of Siena|
|Siena, Italy, 53100|
|Principal Investigator:||Michele Maio, MD||Medical Oncology and Immunotherapy Unit, University Hospital of Siena|