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A Clinical Study With Tremelimumab as Monotherapy in Malignant Mesothelioma

Primary Purpose

Malignant Mesothelioma

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Tremelimumab
Sponsored by
Azienda Ospedaliera Universitaria Senese
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Mesothelioma focused on measuring Tremelimumab, Malignant Mesothelioma, anti-CTLA-4 mAb

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Oncology and Immunotherapy Unit, University Hospital of Siena

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single arm of Tremelimumab

Arm Description

Tremelimumab is administered at 15 mg/kg on day 1 every 12 weeks for 4 doses

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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.

Full Information

First Posted
July 18, 2012
Last Updated
July 20, 2012
Sponsor
Azienda Ospedaliera Universitaria Senese
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1. Study Identification

Unique Protocol Identification Number
NCT01649024
Brief Title
A Clinical Study With Tremelimumab as Monotherapy in Malignant Mesothelioma
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Universitaria Senese

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Mesothelioma
Keywords
Tremelimumab, Malignant Mesothelioma, anti-CTLA-4 mAb

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single arm of Tremelimumab
Arm Type
Experimental
Arm Description
Tremelimumab is administered at 15 mg/kg on day 1 every 12 weeks for 4 doses
Intervention Type
Drug
Intervention Name(s)
Tremelimumab
Other Intervention Name(s)
CP-675,206
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Objective tumor response by modified Response Evaluation Criteria in Solid Tumor (RECIST)
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
Time Frame
Weeks 24
Secondary Outcome Measure Information:
Title
Disease control rate
Description
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
Time Frame
1 year
Title
Progression free survival
Description
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
Time Frame
1 year
Title
Safety
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Maio, MD
Organizational Affiliation
Medical Oncology and Immunotherapy Unit, University Hospital of Siena
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Oncology and Immunotherapy Unit, University Hospital of Siena
City
Siena
ZIP/Postal Code
53100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
24035405
Citation
Calabro L, Morra A, Fonsatti E, Cutaia O, Amato G, Giannarelli D, Di Giacomo AM, Danielli R, Altomonte M, Mutti L, Maio M. Tremelimumab for patients with chemotherapy-resistant advanced malignant mesothelioma: an open-label, single-arm, phase 2 trial. Lancet Oncol. 2013 Oct;14(11):1104-1111. doi: 10.1016/S1470-2045(13)70381-4. Epub 2013 Sep 11.
Results Reference
derived

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A Clinical Study With Tremelimumab as Monotherapy in Malignant Mesothelioma

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