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Study of CP-675,206 in Refractory Melanoma

NCT ID: NCT00254579

Last Updated: 2012-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Refractory Melanoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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15 mg/kg CP-675,206

Group Type EXPERIMENTAL

CP-675,206

Intervention Type DRUG

15 mg/kg Q12W dosing regimen

Interventions

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CP-675,206

15 mg/kg Q12W dosing regimen

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Scottsdale, Arizona, United States

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Bentonville, Arkansas, United States

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Fayetteville, Arkansas, United States

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Little Rock, Arkansas, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Aurora, Colorado, United States

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Stamford, Connecticut, United States

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Ocoee, Florida, United States

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Orlando, Florida, United States

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Orlando, Florida, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Louisville, Kentucky, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Buffalo, New York, United States

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New York, New York, United States

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Chapel Hill, North Carolina, United States

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Durham, North Carolina, United States

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Pfizer Investigational Site

Columbus, Ohio, United States

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Columbus, Ohio, United States

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Bethlehem, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Salt Lake City, Utah, United States

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Federal Way, Washington, United States

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Lakewood, Washington, United States

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Seattle, Washington, United States

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Seattle, Washington, United States

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Tacoma, Washington, United States

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Madison, Wisconsin, United States

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Ciudad de Buenos Aires, Buenos Aires, Argentina

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Waratah, New South Wales, Australia

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Westmead, New South Wales, Australia

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Woolloongabba, Queensland, Australia

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East Melbourne, Victoria, Australia

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Nedlands, Western Australia, Australia

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Hamilton, Ontario, Canada

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Lille, Cedex, France

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Paris, , France

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Villejuif, , France

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Berlin, , Germany

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Frankfurt, , Germany

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Kiel, , Germany

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Tübingen, , Germany

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Meldola, FC, , Italy

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Milan, , Italy

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Milan, , Italy

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Milan, , Italy

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Barcelona, Barcelona, Spain

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Madrid, Madrid, Spain

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Pamplona, Navarre, Spain

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Zaragoza, Zaragoza, Spain

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Truro, Cornwall, United Kingdom

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Northwood, Middlesex, United Kingdom

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Sutton, Surrey, United Kingdom

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Newcastle upon Tyne, Tyne and Wear, United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Countries

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United States Argentina Australia Canada France Germany Italy Spain United Kingdom

Other Identifiers

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A3671008

Identifier Type: -

Identifier Source: org_study_id

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