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
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Malignant Melanoma
Both
Malignant Melanoma
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Rate of Grade 2,3,4 Diarrhea - patients on study drug.
Authority:
United States: Food and Drug Administration
Study ID:
CA184-007
NCT ID:
NCT00135408
Start Date:
November 2005
Completion Date:
July 2007
Related Keywords:
- Malignant Melanoma
- Unresectable Stage III or IV Malignant Melanoma
- Melanoma
Name | Location |
|---|---|
| University of Washington Medical Center | Seattle, Washington 98195-6043 |
| Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
| USC Norris Comprehensive Cancer Center | Los Angeles, California 90089 |
| San Francisco Oncology Associates | San Francisco, California 94115 |
| The Angeles Clinic And Research Institution | Santa Monica, California 90404 |
