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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
Sponsor:
Collaborator:
Medarex
Information provided by:
Bristol-Myers Squibb

Study Description
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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

Study Design
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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

Arms and Interventions
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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)


Outcome Measures
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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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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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


Locations
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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
Canada
Local Institution
Kitchener, Canada
Local Institution
Moncton, Canada
Israel
Local Institution
Tel Aviv, Israel
Italy
Local Institution
Forli, Italy
Peru
Local Institution
Lima, Peru
United Kingdom
Local Institution
Hull, United Kingdom
Sponsors and Collaborators
Bristol-Myers Squibb
Medarex
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Budesonide
Ipilimumab
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists