PATIENTS WITH UNRESECTABLE MALIGNANT MESOTHELIOMA MedDRA version: 9.1 Level: LLT Classification code 10059518 Term: Pleural mesothelioma malignant
Conditions
Interventions
Product Name: tremelimumab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: anti-CTLA4 monoclonal antibody
CAS Number: 745013-59-6
Concentration unit: mg milligram(s)
Co
Sponsors
AZIENDA OSPEDALIERA SENESE
Eligibility
Sex/Gender
All
Inclusion criteria
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 o Platelet count > 100000/mm3 o Absolute granulocyte count > 1500/mm3 o Hemoglobin > 9 g/dL o Bilirubin total 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) 2) To assess the progression-free survival in treated patients 3) To evaluate qualitative and quantitative changes in cellular and humoral immune responses 4) To define toxicity profile;Primary end point(s): To assess the rate of objective clinical responses 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. | — |
Countries
Italy
Outcome results
None listed