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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT00135408

Public ClinicalTrials.gov record NCT00135408. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 7, 2026, 9:02 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Randomized, Double-Blind, Placebo-Controlled Phase II Study Comparing the Safety of MDX-010 (BMS-734016) Administered With or Without Prophylactic Oral Budesonide (Entocort EC) in Patients With Previously Treated Unresectable Stage III or IV Malignant Melanoma

Study identification

NCT ID
NCT00135408
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Bristol-Myers Squibb
Industry
Enrollment
115 participants

Conditions and interventions

Interventions

  • Ipilimumab+ Budesonide Drug
  • Ipilimumab+ Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2005
Primary completion
Jun 30, 2007
Completion
Jun 30, 2007
Last update posted
Sep 27, 2016

2005 – 2007

United States locations

U.S. sites
4
U.S. states
3
U.S. cities
4
Facility City State ZIP Site status
Not listed Los Angeles California
Not listed San Francisco California
Not listed Charlotte North Carolina
Not listed Seattle Washington

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00135408, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 27, 2016 · Synced May 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00135408 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →