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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatocellular Carcinoma Hepatitis C Virus Chronic Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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CP 675,206

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No