Clincosm LogoSign in Get a demo

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

Sponsor
Clinica Universidad de Navarra, Universidad de Navarra (Other)
Overall Status
Completed
CT.gov ID
NCT01008358
Collaborator
Pfizer (Industry)
20
Enrollment
3
Locations
41
Duration (Months)
6.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: CP 675,206
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Trial of Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma
Study Start Date :
Dec 1, 2008
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
May 1, 2012

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Universitario Reina Sofía Córdoba Spain
2 Hospital Universitario 12 de Octubre Madrid Spain
3 Clinica Universitaria de Navarra Pamplona Spain

Sponsors and Collaborators

  • Clinica Universidad de Navarra, Universidad de Navarra
  • Pfizer

Investigators

  • Study Director: Jesús Prieto-Valtuena, MD, PhD, Clinica Universidad de Navarra

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT01008358
Other Study ID Numbers:
  • CT-2007-01
  • EudraCT number 2008-001177-15
First Posted:
Nov 4, 2009
Last Update Posted:
Jun 8, 2012
Last Verified:
Jun 1, 2012
Additional relevant MeSH terms:
Hepatitis C
Carcinoma
Carcinoma, Hepatocellular
Tremelimumab

Study Results

No Results Posted as of Jun 8, 2012