Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma

Phase 2

Completed

• Conditions: Hepatitis C Virus Chronic Infection; Hepatocellular Carcinoma

• Registration Number: NCT01008358
• Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

Brief Summary

CP-675,206 (tremelimumab) is a fully humanized monoclonal antibody that binds to activated T lymphocytes and by enhancing their activation may produce a stimulation of the immune response against tumoral or viral antigens. In this clinical trial, the ability of tremelimumab to produce tumor responses among hepatitis C virus-infected patients with hepatocellular carcinoma not amenable to other therapies will be explored. Besides, the effect on the replication of the virus will be analysed.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-11-03
• Study First Submitted QC: 2009-11-03
• Study First Posted: 2009-11-04
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-07
• Last Update Posted: 2012-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Unequivocal diagnosis of HCC
• unresectable disease not amenable to locoregional treatment.
• a 4-week washout period after sorafenib or any other systemic agent
• a 2-month washout period after internal or external radiation
• HCV chronic infection
• Child-Pugh stage A or B
• Measurable disease according to RECIST criteria
• ECOG < 2
• expected survival > 3 months
• Adequate liver, renal and blood functions
• ability to sign informed consent

Exclusion Criteria

• previous treatment with an anti-CTL-4 agent
• serious infections or disease compromising general health status
• autoimmune disease that requires therapy
• treatment with immunosuppressors
• treatment with investigational agents
• other neoplasms except skin and bladder superficial tumors
• pregnancy or lactation
• SNC metastasis
• HIV infection
• relevant heart disease (NYHA class III or IV)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Tumor response by Response Evaluation Criteria In Solid Tumors (RECIST)

Secondary Outcome Measures

Name	Time	Method
Changes in Hepatitis C Virus (HCV) viral load

Trial Locations

Locations (3)

Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Spain

Clinica Universitaria de Navarra; 🇪🇸 Pamplona, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain