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Completed

NCT Number: NCT01008358

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

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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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms HEPATITIS C VIRUS CHRONIC INFECTION Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Universitario Reina Sofía, Córdoba, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CP 675,206

Biological

Primary outcomes

  1. Tumor response by Response Evaluation Criteria In Solid Tumors (RECIST)

Secondary outcomes

  1. Changes in Hepatitis C Virus (HCV) viral load

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Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Nov 4, 2009
Registry last updated
Jun 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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