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

Phase 2

Completed

• Conditions: Malignant Melanoma
• Interventions: Drug: Ipilimumab+ Placebo; Drug: Ipilimumab+ Budesonide

• Registration Number: NCT00135408
• Lead Sponsor: Bristol-Myers Squibb

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

Not available

Study Timeline

• Study First Submitted: 2005-08-25
• Study First Submitted QC: 2005-08-25
• Study First Posted: 2005-08-26
• Study Start: 2005-12
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-26
• Last Update Posted: 2016-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A1	Ipilimumab+ Placebo	-
A2	Ipilimumab+ Budesonide	-

Primary Outcome Measures

Name	Time	Method
Rate of Grade 2,3,4 Diarrhea - patients on study drug.

Secondary Outcome Measures

Name	Time	Method
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	at Week 24

Trial Locations

Locations (1)

Local Institution; 🇬🇧 Hull, United Kingdom