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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

251

Phase

  • 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

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
Intervention / Treatment
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

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

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

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

December 1, 2005

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

November 14, 2005

First Submitted That Met QC Criteria

November 14, 2005

First Posted (Estimate)

November 16, 2005

Study Record Updates

Last Update Posted (Estimate)

June 7, 2012

Last Update Submitted That Met QC Criteria

June 5, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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