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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00261365
Recruitment Status : Completed
First Posted : December 5, 2005
Last Update Posted : September 29, 2016
Sponsor:
Information provided by:
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Unresectable Stage III or IV Malignant Melanoma Drug: Ipilimumab Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2005
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Ipilimumab

Arms and Interventions
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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)
Active Comparator: A2 Drug: Ipilimumab
Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
Other Names:
  • BMS-734016
  • (MDX-010)


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

Secondary Outcome Measures :
  1. Safety & tumor response are important secondary objectives. Safety evaluated [ Time Frame: on a continuous & ongoing basis ]
  2. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00261365


Locations
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United States, California
Comprehensive Cancer Center
Palm Springs, California, United States, 92262
The Angeles Clinic And Research Institution
Santa Monica, California, United States, 90404
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Denmark
Local Institution
Aarhus C, Denmark, 8000
Local Institution
Odense C, Denmark, 5000
Israel
Local Institution
Jerusalem, Israel, 72080
Italy
Local Institution
Bari, Italy, 70126
Local Institution
Forli', Italy, 47100
Local Institution
Ravenna, Italy, 48100
Local Institution
Rimini, Italy, 47900
Norway
Local Institution
Oslo, Norway, 0310
Peru
Local Institution
Lima, Peru, 43
Local Institution
Lima, Peru, LIMA 11
Sweden
Local Institution
Gothenberg, Sweden, 413 45
Local Institution
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00261365    
Other Study ID Numbers: CA184-004
First Posted: December 5, 2005    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: August 2008
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
 Nevi and Melanomas
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action