A SECOND-LINE, SINGLE ARM, PHASE II CLINICAL STUDY WITH TREMELIMUMAB, A FULLY HUMANIZED ANTI-CTLA-4 MONOCLONAL ANTIBODY, AS MONOTHERAPY IN PATIENTS WITH UNRESECTABLE MALIGNANT MESOTHELIOMA - MESOT-TREM-2008

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10059518Term: Pleural mesothelioma malignant; PATIENTS WITH UNRESECTABLE MALIGNANT MESOTHELIOMA

• Registration Number: EUCTR2008-005171-95-IT
• Lead Sponsor: AZIENDA OSPEDALIERA SENESE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-15
• Last Update Posted: 2 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Histologically or cytologically confirmed malignant mesothelioma
Have received only one prior systemic chemotherapy regimen for advanced mesothelioma
Measurable disease, defined at least 1 unidimemensionally measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan (RECIST criteria).
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
oPlatelet count > 100000/mm3
oAbsolute granulocyte count > 1500/mm3
oHemoglobin > 9 g/dL
oBilirubin total < 2 x ULN (Upper limited normal)
oAST and ALT < 2.5 x ULN (< 5 x ULN if documented liver metastasis are present)
oCreatinine level < 2mg/dl or creatinine clearance > 50 mL/min
Not pregnant or nursing
Fertile patients must use effective contraception
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

History of or significant evidence of risk of chronic inflammatory or autoimmune disease (eg Addison?s disease, multiple sclerosis, Graves disease, Hashimoto?s thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erytematotosus, hypophysitis, pituitary disorders, etc.)
History of diverticulitis
History of 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 non 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
Any condition which, in the judgement of the Investigator, would place the patient at undue risk or interfere with the results of the study
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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the rate of objective clinical responses (CR + PR);Secondary Objective: 1) To estimate disease control rate (proportion of patients with best response of CR+PR+SD) <br>2) To assess the progression-free survival in treated patients<br>3) To evaluate qualitative and quantitative changes in cellular and humoral immune responses <br>4) To define toxicity profile;Primary end point(s): To assess the rate of objective clinical responses <br>Objective tumor response, defined as a confirmed complete response (CR) or partial response (PR), will be assessed using the RECIST criteria or modified RECIST criteria for assessment of response in malignant pleural mesothelioma.