Study of CP-675,206 in Refractory Melanoma

June 5, 2012 updated by: AstraZeneca

A Phase 2, Open Label, Single Arm Study To Evaluate The Efficacy, Safety, Tolerability And Pharmacokinetics Of CP-675,206 In Patients With Advanced Refractory And/Or Relapsed Melanoma

CP-675,206 is a fully human monoclonal antibody (mAb). It binds to the CTLA4 molecule, which is expressed on the surface of activated T lymphocytes. CP-675,206 is thought to stimulate patients' immune systems to attack their tumors. CP-675,206 is not expected to have a direct effect on tumor cells. CP-675,206 been shown to induce durable tumor responses in patients with metastatic melanoma in Phase 1 and Phase 2 clinical studies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
251

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Ciudad de Buenos Aires, Buenos Aires, Argentina, C1280AEA
        • Research Site
  • Australia
    • New South Wales
      • Waratah, New South Wales, Australia, 2298
        • Research Site
      • Westmead, New South Wales, Australia, 2145
        • Research Site
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Research Site
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Research Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Research Site
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Research Site
  • France
      • Paris Cedex 13, France, 75651
        • Research Site
      • Villejuif, France, 94805
        • Research Site
    • Cedex
      • Lille, Cedex, France, 59037
        • Research Site
  • Germany
      • Berlin, Germany, 10117
        • Research Site
      • Frankfurt, Germany, 60488
        • Research Site
      • Kiel, Germany, 24105
        • Research Site
      • Tuebingen, Germany, 72076
        • Research Site
  • Italy
      • Meldola, FC, Italy, 47014
        • Research Site
      • Milano, Italy, 20141
        • Research Site
      • Milano, Italy, 20132
        • Research Site
      • Milano, Italy, 20133
        • Research Site
  • Spain
      • Barcelona, Spain, 08036
        • Research Site
      • Madrid, Spain, 28046
        • Research Site
      • Zaragoza, Spain, 50009
        • Research Site
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Research Site
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • Research Site
      • Manchester, United Kingdom, M20 4BX
        • Research Site
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Research Site
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • Research Site
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2RN
        • Research Site
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Research Site
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE4 6BE
        • Research Site
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Research Site
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Research Site
      • Fayetteville, Arkansas, United States, 72703
        • Research Site
      • Little Rock, Arkansas, United States, 72205
        • Research Site
    • California
      • Los Angeles, California, United States, 90095-6970
        • Research Site
      • Los Angeles, California, United States, 90095
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
    • Connecticut
      • Stamford, Connecticut, United States, 06902-3628
        • Research Site
    • Florida
      • Ocoee, Florida, United States, 34761
        • Research Site
      • Orlando, Florida, United States, 32803
        • Research Site
      • Orlando, Florida, United States, 32804
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Research Site
      • Indianapolis, Indiana, United States, 46260
        • Research Site
      • Indianapolis, Indiana, United States, 46202
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21237-3998
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0946
        • Research Site
    • New York
      • Buffalo, New York, United States, 14263
        • Research Site
      • New York, New York, United States, 10016
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7600
        • Research Site
      • Durham, North Carolina, United States, 27710
        • Research Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Pfizer Investigational Site
      • Columbus, Ohio, United States, 43210
        • Research Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15232
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6307
        • Research Site
      • Nashville, Tennessee, United States, 37232
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Research Site
    • Washington
      • Federal Way, Washington, United States, 98003
        • Research Site
      • Lakewood, Washington, United States, 98499
        • Research Site
      • Seattle, Washington, United States, 98104
        • Research Site
      • Seattle, Washington, United States, 98122
        • Research Site
      • Tacoma, Washington, United States, 98405
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Surgically incurable Stage III or IV melanoma
  • One prior systemic treatment for metastatic melanoma
  • Measurable disease
  • Eastern Cooperative Oncology Group (ECOG) PS = 0 or 1

Exclusion Criteria:

  • Melanoma of ocular origin
  • Received prior vaccine
  • Received prior CTLA4-inhibiting agent
  • History of, or significant risk for, chronic inflammatory or autoimmune disease
  • Potential requirement for systemic corticosteroids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 15 mg/kg CP-675,206
Drug: CP-675,206
15 mg/kg Q12W dosing regimen

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
To assess the anti-tumor efficacy, as determined by objective response rate, of intravenous CP-675,206 administered at a dose of 15 mg/kg every 90 days to patients with relapsed or refractory advanced melanoma
Time Frame: Tumor response is assessed every 2-3 months until disease progression
Tumor response is assessed every 2-3 months until disease progression

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Safety
Time Frame: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Pharmaco Kinetic
Time Frame: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Survival
Time Frame: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Health-related QoL
Time Frame: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A3671008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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