Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma
NCT01008358
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- 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
- 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)
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma | |||
| Official Title ICMJE | Phase II Trial of Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma | |||
| 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 Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE |
| |||
| Intervention ICMJE | Biological: CP 675,206 | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Sangro B, Gomez-Martin C, de la Mata M, Iñarrairaegui M, Garralda E, Barrera P, Riezu-Boj JI, Larrea E, Alfaro C, Sarobe P, Lasarte JJ, Pérez-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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 20 | |||
| Original Estimated Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | May 2012 | |||
| Actual Primary Completion Date | May 2012 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Spain | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01008358 | |||
| Other Study ID Numbers ICMJE | CT-2007-01 EudraCT number 2008-001177-15 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Clinica Universidad de Navarra, Universidad de Navarra | |||
| Study Sponsor ICMJE | Clinica Universidad de Navarra, Universidad de Navarra | |||
| Collaborators ICMJE | Pfizer | |||
| Investigators ICMJE |
| |||
| PRS Account | Clinica Universidad de Navarra, Universidad de Navarra | |||
| Verification Date | June 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||