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

Phase 2 Completed 115 enrolled Bristol-Myers Squibb Medarex · collab

RandomizedSingle-groupDouble-blindTreatment

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.

Timeline

Start: 2005-12
Primary completion: 2007-07
Completion: 2007-07

Publications

Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Budesonide	Small molecule	9 mg	Oral
Comparator	Ipilimumab	Monoclonal antibody	10 mg/kg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications