Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

February 27, 2010 updated by: Bristol-Myers Squibb

A Randomized, Double-Blind, Multi-center, Phase II Fixed Dose Study of Multiple Doses of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

The purpose of this clinical research study is to compare the best overall response rate (BORR)(as per modified WHO criteria) in patients with previously treated, therapy-refractory, or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg. The safety of this product will also be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

210

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

  • Australia
    • New South Wales
      • Newcastle, New South Wales, Australia, 2300
        • Local Institution
    • Queensland
      • Brisbane, Queensland, Australia, 4101
        • Local Institution
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution
      • Wodonga, Victoria, Australia, 3690
        • Local Institution
  • Belgium
      • Brussels, Belgium, 1090
        • Local Institution
      • Bruxelles, Belgium, 1200
        • Local Institution
      • Bruxelles, Belgium, 1070
        • Local Institution
  • Brazil
      • Sao Paulo, Brazil, 01509
        • Local Institution
    • Rio Grande Do Sul
      • Centro-Porto Alegre, Rio Grande Do Sul, Brazil, 90020
        • Local Institution
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610
        • Local Institution
    • Sao Paulo
      • Jau, Sao Paulo, Brazil, 17210
        • Local Institution
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Local Institution
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution
    • Ontario
      • Kingston, Ontario, Canada, K7L 5P9
        • Local Institution
  • Czech Republic
      • Olomouc, Czech Republic, 775 20
        • Local Institution
      • Praha, Czech Republic, 128 08
        • Local Institution
  • France
      • Clermont Ferrand, France, 63058
        • Local Institution
      • Lyon, France, 69288
        • Local Institution
      • Lyon Cedex 08, France, 69373
        • Local Institution
      • Marseille Cedex 09, France, 13009
        • Local Institution
      • Paris, France, 75010
        • Local Institution
      • Rennes, France, 35042
        • Local Institution
      • Toulouse, France, 31059
        • Local Institution
      • Vandoeuvre Les Nancy, France, 54511
        • Local Institution
    • Cedex
      • Brest, Cedex, France, 29200
        • Local Institution
  • Germany
      • Berlin, Germany, 12200
        • Local Institution
      • Essen, Germany, 45122
        • Local Institution
      • Heidelberg, Germany, 69115
        • Local Institution
      • Jena, Germany, 07740
        • Local Institution
      • Kiel, Germany, 24105
        • Local Institution
      • Mannheim, Germany, 68169
        • Local Institution
      • Wurzburg, Germany, 97080
        • Local Institution
  • Hungary
      • Pécs, Hungary, 7624
        • Local Institution
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2199
        • Local Institution
      • Pretoria, Gauteng, South Africa, 0181
        • Local Institution
      • Pretoria, Gauteng, South Africa, 0041
        • Local Institution
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7506
        • Local Institution
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center
    • California
      • Laverne, California, United States, 91750
        • Wilshire Oncology Medical Group Inc
      • San Diego, California, United States, 92121
        • Scripps Cancer Center
      • Santa Monica, California, United States, 90404
        • The Angeles Clinic And Research Institution
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School Of Medicine
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist Cancer Institute
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Comprehensive Cancer Center
      • Orlando, Florida, United States, 32806
        • MD Anderson Cancer Center Orlando
      • West Palm Beach, Florida, United States, 33401
        • Palm Beach Cancer Institute
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Oncology Specialists, SC
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • American Health Network
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Harry And Jeanette Weinberg Cancer Inst At Franklin Square
    • Minnesota
      • Robbinsdale, Minnesota, United States, 55422
        • Hubert H. Humphrey Cancer Center
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Ellis Fischel Cancer Center
      • St Joseph, Missouri, United States, 64507
        • St Joseph Oncology Inc
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Presbyterian Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital Cancer Center Research
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Cancer Centers of the Carolinas
    • Texas
      • Dallas, Texas, United States, 75246
        • Mary Crowley Medical Research Center
      • Dallas, Texas, United States, 75230
        • Center For Oncology Research & Treatment, P.A.

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: ipilimumab (MDX-010, BMS-734016)
IV solution, IV, 0.3mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
Experimental: 2
Drug: Ipilimumab
IV solution, IV, 3 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
Drug: Ipilimumab
IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
Experimental: 3
Drug: Ipilimumab
IV solution, IV, 3 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
Drug: Ipilimumab
IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
estimate BORR in patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg.

Secondary Outcome Measures

Outcome Measure
estimate overall survival
estimate survival rate at one year
evaluate health-related quality of life
estimate progression free survival rate at Week 12 assessment and other timepoints
estimate disease control rate at various time points
obtain pharmacokinetic samples for population PK analysis

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Collaborators

Medarex

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

February 9, 2006

First Submitted That Met QC Criteria

February 9, 2006

First Posted (Estimate)

February 10, 2006

Study Record Updates

Last Update Posted (Estimate)

March 2, 2010

Last Update Submitted That Met QC Criteria

February 27, 2010

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA184-022

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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