Phase II Study to Determine Predictive Markers of Response to BMS-734016 (MDX-010)

September 27, 2016 updated by: Bristol-Myers Squibb

An Exploratory Study to Determine Potential Predictive Markers of Response and/or Toxicity in Patients With Unresectable Stage III or IV Malignant Melanoma Randomized and Treated With Ipilimumab (MDX-010/BMS-734016) at Two Dose Levels

The purpose of this study is to identify candidate markers predictive of response and/or serious toxicity to BMS-734016 (MDX-010).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2
  • Phase 1

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

  • Denmark
      • Aarhus C, Denmark, 8000
        • Local Institution
      • Odense C, Denmark, 5000
        • Local Institution
  • Israel
      • Jerusalem, Israel, 72080
        • Local Institution
  • Italy
      • Bari, Italy, 70126
        • Local Institution
      • Forli', Italy, 47100
        • Local Institution
      • Ravenna, Italy, 48100
        • Local Institution
      • Rimini, Italy, 47900
        • Local Institution
  • Norway
      • Oslo, Norway, 0310
        • Local Institution
  • Peru
      • Lima, Peru, LIMA 11
        • Local Institution
      • Lima, Peru, 43
        • Local Institution
  • Sweden
      • Gothenberg, Sweden, 413 45
        • Local Institution
      • Stockholm, Sweden, 171 76
        • Local Institution
  • United States
    • California
      • Palm Springs, California, United States, 92262
        • Comprehensive Cancer Center
      • Santa Monica, California, United States, 90404
        • The Angeles Clinic And Research Institution
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

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:

  • Histologic or cytologic diagnosis of unresectable State III or IV malignant melanoma (excluding ocular melanoma); A pre- and post-treatment fresh core or excision tumor biopsy must be provided.

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: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A1
Drug: Ipilimumab
Solution, Intravenous, 3 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
Other Names:
  • BMS-734016
  • (MDX-010)
Drug: Ipilimumab
Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
Other Names:
  • BMS-734016
  • (MDX-010)
Active Comparator: A2
Drug: Ipilimumab
Solution, Intravenous, 3 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
Other Names:
  • BMS-734016
  • (MDX-010)
Drug: Ipilimumab
Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
Other Names:
  • BMS-734016
  • (MDX-010)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Purpose - to identify candidate markers predictive of response and/or serious toxicity to MDX-101 (BMS-734016)
Time Frame: on a continuous & ongoing basis
on a continuous & ongoing basis

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety & tumor response are important secondary objectives. Safety evaluated
Time Frame: on a continuous & ongoing basis
on a continuous & ongoing basis
Tumor response measured
Time Frame: starting @ wk 12 through wk 24. Those continuing on therapy after wk 24 have tumor responses evaluated every 3 months
starting @ wk 12 through wk 24. Those continuing on therapy after wk 24 have tumor responses evaluated every 3 months

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

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

November 1, 2005

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

December 1, 2005

First Submitted That Met QC Criteria

December 1, 2005

First Posted (Estimate)

December 5, 2005

Study Record Updates

Last Update Posted (Estimate)

September 29, 2016

Last Update Submitted That Met QC Criteria

September 27, 2016

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA184-004

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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