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Hepatocellular CarcinomaPhase 2NCT01008358

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

A Phase 2 study testing CP 675,206 in people with Hepatocellular Carcinoma and Hepatitis C Virus Chronic Infection, run by Clinica Universidad de Navarra, Universidad de Navarra at 3 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CP 675,206
How many people
20 participants
Where
3 sitesSpain
Study dates
Dec 2008to May 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • Measurable disease according to RECIST criteria
  • ECOG < 2
  • expected survival > 3 months
  • Adequate liver, renal and blood functions
  • ability to sign informed consent

Who cannot join

  • 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
Show all 10Show fewer
  • pregnancy or lactation
  • SNC metastasis
  • HIV infection
  • relevant heart disease (NYHA class III or IV)

Trial locations and contacts

3 sites in 1 country.

Spain3 sites

  • Hospital Universitario Reina Sofía

    Córdoba

  • Hospital Universitario 12 de Octubre

    Madrid

  • Clinica Universitaria de Navarra

    Pamplona

Other trials in Spain

About this study

Official title: Phase II Trial of 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.

Being tested
CP 675,206
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CP 675,206Biological

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2009 (estimated)
  2. Study startDec 2008
  3. Primary completionMay 2012
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01008358
Sponsor's protocol ID
CT-2007-01
Other IDs
EudraCT number 2008-001177-15
Status last verified
Jun 2012
First submitted
3 Nov 2009
Last updated
8 Jun 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23466307

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CP 675,206 in people with Hepatocellular Carcinoma and Hepatitis C Virus Chronic Infection, run by Clinica Universidad de Navarra, Universidad de Navarra at 3 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor response by Response Evaluation Criteria In Solid Tumors (RECIST). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01008358, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2012.

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