Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Medarex
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00135408
First received: August 25, 2005
Last updated: February 27, 2010
Last verified: August 2008
  Purpose

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 Intervention Phase
Malignant Melanoma
Drug: Ipilimumab+ Placebo
Drug: Ipilimumab+ Budesonide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 110
Study Start Date: November 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135408

Locations
United States, California
Usc Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
San Francisco Oncology Associates
San Francisco, California, United States, 94115
The Angeles Clinic And Research Institution
Santa Monica, California, United States, 90404
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
United States, Washington
University Of Washington Medical Center
Seattle, Washington, United States, 98109
Canada, New Brunswick
Local Institution
Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Ontario
Local Institution
Kitchener, Ontario, Canada, N2G 1G3
Israel
Local Institution
Tel Aviv, Israel, IL-64239
Italy
Local Institution
Forli', Italy, 47100
Peru
Local Institution
Lima, Peru, 43
United Kingdom
Local Institution
Hull, Yorkshire, United Kingdom, HU8 9HE
Sponsors and Collaborators
Bristol-Myers Squibb
Medarex
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00135408     History of Changes
Other Study ID Numbers: CA184-007
Study First Received: August 25, 2005
Last Updated: February 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Unresectable Stage III or IV Malignant Melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Budesonide
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014