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Comparison Study of MDX-010 (CTLA-4) Alone and Combined With DTIC in the Treatment of Metastatic Melanoma
This study has been completed.
Study NCT00050102   Information provided by Medarex
First Received: November 21, 2002   Last Updated: June 23, 2005   History of Changes

November 21, 2002
June 23, 2005
October 2002
 
 
 
Complete list of historical versions of study NCT00050102 on ClinicalTrials.gov Archive Site
 
 
 
Comparison Study of MDX-010 (CTLA-4) Alone and Combined With DTIC in the Treatment of Metastatic Melanoma
A Randomized Study Comparing MDX-010 (CTLA-4) Alone or in Combination With DTIC in the Treatment of Patients With Chemotherapy Naїve Metastatic Melanoma.

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.

 
Phase II
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Melanoma
Drug: Treatment of metastatic melanoma
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00050102
 
MDX010-08
Medarex
 
 
Medarex
August 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP