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

Completed · Phase 2

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT00050102

Run by

Bristol-Myers Squibb

Starts

2002-10-01

Expected to finish

2004-02-01

Last updated by the study team

2011-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arizona Cancer Center — Tucson, Arizona, United States
• Pacific Shores Medical Group — Long Beach, California, United States
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Northern California Melanoma Center — San Francisco, California, United States
• Cancer Institute Medical Group — Santa Monica, California, United States
• Indiana Oncology/ Hematology Consultants — Indianapolis, Indiana, United States
• Piedmont Oncology Specialists — Charlotte, North Carolina, United States
• Joe Arrington Cancer. Research & Treatment Center — Lubbock, Texas, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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