Status:
COMPLETED
A Study of MDX-010 (BMS-734016) Administered With or Without Prophylactic Oral Budesonide
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Medarex
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to determine Efficacy, Safety and Tolerability of MDX-010 (BMS-734016) administered with or without Prophylactic Oral Budesonide.
Eligibility Criteria
Inclusion
- Histologic or cytologic diagnosis of unresectable Stage III or IV malignant melanoma (excluding ocular melanoma)
- Flexible Sigmoidoscopy and colonic biopsy required
Exclusion
- Patients with active, untreated central nervous system metastasis. Patients with autoimmune disease.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00135408
Start Date
December 1 2005
End Date
July 1 2007
Last Update
September 28 2016
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Los Angeles, California, United States
2
San Francisco, California, United States
3
Charlotte, North Carolina, United States
4
Seattle, Washington, United States