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Sponsors and Collaborators: |
Bristol-Myers Squibb Medarex |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00135408 |
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 |
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Malignant Melanoma |
Drug: Ipilimumab+ Placebo Drug: Ipilimumab+ Budesonide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Single Group Assignment, Safety Study |
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 |
Estimated Enrollment: | 110 |
Study Start Date: | November 2005 |
Study Completion Date: | July 2007 |
Arms | Assigned Interventions |
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A1: Active Comparator |
Drug: Ipilimumab+ Placebo
Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
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A2: Active Comparator |
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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
San Francisco Oncology Associates | |
San Francisco, California, United States, 94115 | |
Usc Norris Comprehensive Cancer Center | |
Los Angeles, California, United States, 90033 | |
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, Yorkshire | |
Local Institution | |
Hull, Yorkshire, United Kingdom, HU8 9HE |
Study ID Numbers: | CA184-007 |
Study First Received: | August 25, 2005 |
Last Updated: | October 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00135408 |
Health Authority: | United States: Food and Drug Administration |
Unresectable Stage III or IV Malignant Melanoma |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Budesonide |
Neuroepithelioma Nevus Neuroendocrine Tumors Melanoma |
Anti-Inflammatory Agents Respiratory System Agents Neoplasms by Histologic Type Neoplasms, Nerve Tissue Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Hormones |
Glucocorticoids Pharmacologic Actions Neoplasms Autonomic Agents Therapeutic Uses Nevi and Melanomas Peripheral Nervous System Agents Bronchodilator Agents |