NCT01008358

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Dec 2008

Typical duration for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

June 8, 2012

Status Verified

June 1, 2012

Enrollment Period

3.4 years

First QC Date

November 3, 2009

Last Update Submit

June 7, 2012

Conditions

Hepatocellular CarcinomaHepatitis C Virus Chronic Infection

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Changes in Hepatitis C Virus (HCV) viral load

Interventions

CP 675,206BIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Universitario Reina Sofía

Córdoba, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Clinica Universitaria de Navarra

Pamplona, Spain

Location

Related Publications (1)

  • 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.

    PMID: 23466307DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Jesús Prieto-Valtuena, MD, PhD

    Clinica Universidad de Navarra

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2009

First Posted

November 4, 2009

Study Start

December 1, 2008

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

June 8, 2012

Record last verified: 2012-06

Locations

ES(3)