A Study of MDX-010 (BMS-734016) Administered With or Without Prophylactic Oral Budesonide

Completed · Phase 2 · Has a placebo group

Conditions studied: Malignant Melanoma

In brief

The purpose of the study is to determine Efficacy, Safety and Tolerability of MDX-010 (BMS-734016) administered with or without Prophylactic Oral Budesonide.

Key facts

Study ID

NCT00135408

Run by

Bristol-Myers Squibb

People needed

115

Starts

2005-12-01

Expected to finish

2007-07-01

Last updated by the study team

2016-09-28

Who can join

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

You may qualify if…

• Histologic or cytologic diagnosis of unresectable Stage III or IV malignant melanoma (excluding ocular melanoma)
• Flexible Sigmoidoscopy and colonic biopsy required

You may not qualify if…

• Patients with active, untreated central nervous system metastasis. Patients with autoimmune disease.

Where it is running

• Study site — Los Angeles, California, United States
• Study site — San Francisco, California, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Seattle, Washington, United States
• Local Institution — Kitchener, Canada
• Local Institution — Moncton, Canada
• Local Institution — Tel Aviv, Israel
• Local Institution — Forlì, Italy
• Local Institution — Lima, Peru
• Local Institution — Hull, United Kingdom

Full record on ClinicalTrials.gov

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