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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01008358
• Other study ID #: CT-2007-01
• Secondary ID: EudraCT number 2
• Status: Completed
• Phase: Phase 2
• First received: November 3, 2009
• Last updated: June 7, 2012
• Start date: December 2008
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatitis C
• Hepatitis C Virus Chronic Infection
• Hepatocellular Carcinoma

Intervention

Biological:
• CP 675,206

Locations

Country	Name	City	State
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Clinica Universitaria de Navarra	Pamplona

Sponsors (2)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra	Pfizer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response by Response Evaluation Criteria In Solid Tumors (RECIST)			No
Secondary	Changes in Hepatitis C Virus (HCV) viral load			No