Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma, Hepatitis C Virus Chronic Infection
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
CP 675,206
Sponsored by

About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
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)
Sites / Locations
- Hospital Universitario Reina Sofía
- Hospital Universitario 12 de Octubre
- Clinica Universitaria de Navarra
Outcomes
Primary Outcome Measures
Tumor response by Response Evaluation Criteria In Solid Tumors (RECIST)
Secondary Outcome Measures
Changes in Hepatitis C Virus (HCV) viral load
Full Information
NCT ID
NCT01008358
First Posted
November 3, 2009
Last Updated
June 7, 2012
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT01008358
Brief Title
Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma
Official Title
Phase II Trial of Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Hepatitis C Virus Chronic Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
CP 675,206
Primary Outcome Measure Information:
Title
Tumor response by Response Evaluation Criteria In Solid Tumors (RECIST)
Secondary Outcome Measure Information:
Title
Changes in Hepatitis C Virus (HCV) viral load
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesús Prieto-Valtuena, MD, PhD
Organizational Affiliation
Clinica Universidad de Navarra
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitario Reina Sofía
City
Córdoba
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
23466307
Citation
Sangro B, Gomez-Martin C, de la Mata M, Inarrairaegui M, Garralda E, Barrera P, Riezu-Boj JI, Larrea E, Alfaro C, Sarobe P, Lasarte JJ, Perez-Gracia JL, Melero I, Prieto J. A clinical trial of CTLA-4 blockade with tremelimumab in patients with hepatocellular carcinoma and chronic hepatitis C. J Hepatol. 2013 Jul;59(1):81-8. doi: 10.1016/j.jhep.2013.02.022. Epub 2013 Mar 4.
Results Reference
derived
Learn more about this trial
Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma
We'll reach out to this number within 24 hrs