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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Malignant Melanoma

Treatments: Drug: Ipilimumab+ Placebo; Drug: Ipilimumab+ Budesonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00135408

CA184-007

Details and patient eligibility

About

The purpose of the study is to determine Efficacy, Safety and Tolerability of MDX-010 (BMS-734016) administered with or without Prophylactic Oral Budesonide.

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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115 participants in 2 patient groups

A1

Active Comparator group

Treatment:

Drug: Ipilimumab+ Placebo

A2

Active Comparator group

Treatment:

Drug: Ipilimumab+ Budesonide