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Comparison Study of MDX-010 (CTLA-4) Alone and Combined With DTIC in the Treatment of Metastatic Melanoma

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: NCT00050102
Recruitment Status : Completed
First Posted : November 22, 2002
Last Update Posted : January 28, 2011
Information provided by:
Bristol-Myers Squibb

Brief Summary:
The objectives of this study are to determine the safety and activity profile of multiple doses of MDX-010, and to determine the whether the addition of cytotoxic chemotherapy (decarbazine [DTIC]) can augment the effects of MDX-010 in patients with chemotherapy naïve metastatic melanoma with a tolerable toxicity profile.

Condition or disease Intervention/treatment Phase
Melanoma Drug: MDX-010 (CTLA-4) Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Study Comparing MDX-010 (CTLA-4) Alone or in Combination With DTIC in the Treatment of Patients With Chemotherapy Naїve Metastatic Melanoma.
Study Start Date : October 2002
Primary Completion Date : February 2004
Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Ipilimumab
U.S. FDA Resources

Information from the National Library of Medicine

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

Inclusion Criteria

  • Clinical diagnosis of unresectable metastatic melanoma.
  • No prior chemotherapy for melanoma, and no chemotherapy for other malignancies within 5 years and at least 4 weeks since treatment (surgery, radiation, or immunotherapy) for melanoma.

Exclusion Criteria

Patients who exhibit any of the following conditions at screening will not be eligible for admission into the study:

  • Any other prior malignancy, except for the following: adequately treated basal or squamous cell skin cancer or superficial bladder cancer, or any other cancer from which the patient has been disease-free for >=5 years.
  • Active autoimmune disease.
  • Active infection requiring therapy, or chronic active HBV or HCV, or confirmed reactivity with HIV tests.

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): NCT00050102

United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
Pacific Shores Medical Group
Long Beach, California, United States, 90813
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Northern California Melanoma Center
San Francisco, California, United States, 94109
Cancer Institute Medical Group
Santa Monica, California, United States, 90404
United States, Indiana
Indiana Oncology/ Hematology Consultants
Indianapolis, Indiana, United States, 46237
United States, North Carolina
Piedmont Oncology Specialists
Charlotte, North Carolina, United States, 28207
United States, Texas
Joe Arrington Cancer. Research & Treatment Center
Lubbock, Texas, United States, 79410
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00050102     History of Changes
Other Study ID Numbers: MDX010-08
CA184-013 ( Other Identifier: BMS )
First Posted: November 22, 2002    Key Record Dates
Last Update Posted: January 28, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas