We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00135408
Recruitment Status : Completed
First Posted : August 26, 2005
Last Update Posted : September 28, 2016
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Malignant Melanoma Drug: Ipilimumab+ Placebo Drug: Ipilimumab+ Budesonide Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : December 2005
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Active Comparator: A1 Drug: Ipilimumab+ Placebo
Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
Other Names:
  • BMS-734016
  • (MDX-010)

Active Comparator: A2 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.
Other Names:
  • BMS-734016
  • (MDX-010)

Primary Outcome Measures :
  1. Rate of Grade 2,3,4 Diarrhea - patients on study drug.

Secondary Outcome Measures :
  1. 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 [ Time Frame: at Week 24 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00135408

Layout table for location information
United States, California
Los Angeles, California, United States
San Francisco, California, United States
United States, North Carolina
Charlotte, North Carolina, United States
United States, Washington
Seattle, Washington, United States
Local Institution
Kitchener, Canada
Local Institution
Moncton, Canada
Local Institution
Tel Aviv, Israel
Local Institution
Forli, Italy
Local Institution
Lima, Peru
United Kingdom
Local Institution
Hull, United Kingdom
Sponsors and Collaborators
Bristol-Myers Squibb
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00135408    
Other Study ID Numbers: CA184-007
First Posted: August 26, 2005    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016
Keywords provided by Bristol-Myers Squibb:
Unresectable Stage III or IV Malignant Melanoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists