NCT01008358CompletedPhase 2
Phase II Trial of Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma
Clinica Universidad de Navarra, Universidad de Navarra3 sites in 1 country20 target enrollmentStarted: December 1, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 3
- Primary Endpoint
- Tumor response by Response Evaluation Criteria In Solid Tumors (RECIST)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Tumor response by Response Evaluation Criteria In Solid Tumors (RECIST)
Secondary Outcomes
- Changes in Hepatitis C Virus (HCV) viral load
Investigators
Study Sites (3)
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