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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Medarex
• Treatments: Antibodies, Monoclonal; Budesonide; Ipilimumab

Criteria

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.