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

Tracking Information
First Received Date ^ICMJE	August 25, 2005
Last Updated Date	October 10, 2008
Start Date ^ICMJE	November 2005
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: April 28, 2007)	Rate of Grade 2,3,4 Diarrhea - patients on study drug.
Original Primary Outcome Measures ^ICMJE (submitted: September 13, 2005)	Rate of Grade 2,3,4 Diarrhea - patients on study drug.
Change History	Complete list of historical versions of study NCT00135408 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 3, 2007)	Safety monitored w/follow-up period. Assess Best Objective response, Disease control rate, progression free survival, overall survival, duration/best objective response, Time/best objective response. PK, immunogenicity & pharmacodynamic analysis [ Time Frame: at Week 24 ]
Original Secondary Outcome Measures ^ICMJE (submitted: September 13, 2005)	Safety monitored w/follow-up period. Assess @ WK 24: Best Objective response, Disease control rate, progression free survival, overall survival, duration/best objective response, Time/best objective response. PK, immunogenicity & pharmacodynamic analysis

Descriptive Information
Brief Title ^ICMJE	A Study of MDX-010 (BMS-734016) Administered With or Without Prophylactic Oral Budesonide
Official Title ^ICMJE	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
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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Single Group Assignment, Safety Study
Condition ^ICMJE	Malignant Melanoma
Intervention ^ICMJE	Drug: Ipilimumab+ Placebo Drug: Ipilimumab+ Budesonide
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	110
Completion Date	July 2007
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Histologic or cytologic diagnosis of unresectable Stage III or IV malignant melanoma (excluding ocular melanoma) Flexible Sigmoidoscopy and colonic biopsy required Exclusion Criteria: Patients with active, untreated central nervous system metastasis. Patients with autoimmune disease.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada, Israel, Italy, Peru, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00135408
Responsible Party
Study ID Numbers ^ICMJE	CA184-007
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE	Medarex
Investigators ^ICMJE
Information Provided By	Bristol-Myers Squibb
Verification Date	August 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP