NCT00135408

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

Randomized, Double-Blind, Placebo-Controlled Phase II Study Comparing the Safety of MDX-010 (BMS-734016) Administered With or Without Prophylactic Oral Budesonide (Entocort EC) in Patients With Previously Treated Unresectable Stage III or IV Malignant Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	Ipilimumab+ Placebo	Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
DRUG	Ipilimumab+ Budesonide	Solution/Capsule, Intravenous/Oral, 10 mg/kg + 9 mg, 3 weeks (Ipilimumab) + once daily until week 16 (Budesonide), 12 - 48 weeks depending on the response.

Timeline

• Start date: 2005-12-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2005-08-26
• Last updated: 2016-09-28

Locations

10 sites across 6 countries: United States, Canada, Israel, Italy, Peru, United Kingdom