A Study of MDX-010 (BMS-734016) Administered With or Without Prophylactic Oral Budesonide
Phase 2
Completed
- Conditions
- Malignant Melanoma
- Interventions
- Drug: Ipilimumab+ Placebo
- 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
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