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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Malignant Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A1

Group Type ACTIVE_COMPARATOR

Ipilimumab+ Placebo

Intervention Type DRUG

Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.

A2

Group Type ACTIVE_COMPARATOR

Ipilimumab+ Budesonide

Intervention Type DRUG

Solution/Capsule, Intravenous/Oral, 10 mg/kg + 9 mg, 3 weeks (Ipilimumab) + once daily until week 16 (Budesonide), 12 - 48 weeks depending on the response.

Interventions

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Ipilimumab+ Placebo

Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.

Intervention Type DRUG

Ipilimumab+ Budesonide

Solution/Capsule, Intravenous/Oral, 10 mg/kg + 9 mg, 3 weeks (Ipilimumab) + once daily until week 16 (Budesonide), 12 - 48 weeks depending on the response.

Intervention Type DRUG

Other Intervention Names

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BMS-734016 (MDX-010) BMS-734016 (MDX-010)

Eligibility Criteria

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Inclusion Criteria

* Histologic or cytologic diagnosis of unresectable Stage III or IV malignant melanoma (excluding ocular melanoma)
* Flexible Sigmoidoscopy and colonic biopsy required