The Anti-CTLA-4 Monoclonal Antibody Tremelimumab in Malignant Mesothelioma

• Status: Unknown status
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONAL: Preliminary results fron the Study MESOT-TREM-2012 indicate a promising activity of tremelimumab in malignant mesothelioma (MM) patients.

PURPOSE: The proposed study MESOT-TREM-2012 aims to explore the efficacy of a more intensive schedule of treatment with tremelimumab in 29 MM patients. Subjects will receive investigational product every 4 weeks (wks) for 6 doses, followed by doses every 12 wks until confirmed disease progression.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera Universitaria Senese
• Collaborator: MedImmune LLC
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins; Tremelimumab

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed MM

• Have received only one prior systemic chemotherapy platinum-based regimen for advanced MM

• Measurable disease, defined at least 1 unidimensionally measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan (modified 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

• Platelet count > 75000/mm3

• Absolute granulocyte count > 1000/mm3

• Hemoglobin > 9 g/dL

• Bilirubin total < 1.5 x ULN (Upper limited normal), except patients with documented Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dl

• AST and ALT < 2.5 x ULN ( < 5 x ULN if documented liver metastasis are present)

• Creatinine level < 2mg/dl or calculated creatinine clearance > 60 mL/min as determined by the Cockcroft Gault equation.

• 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

Exclusion Criteria:

• Symptomatic chronic inflammatory or autoimmune disease

• Active hepatitis B or C

• Prior treatment with tremelimumab or other anti-CTLA-4 antibody or anti-PD1, anti-PDL-1 agents

• Clinically relevant cardiovascular disease

• 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