A Multi-Center Phase II Study to Evaluate Tumor Response to Ipilimumab (BMS-734016) Monotherapy in Subjects With Melanoma Brain Metastases
16 Years
N/A
Both
Melanoma
Trial Information
A Multi-Center Phase II Study to Evaluate Tumor Response to Ipilimumab (BMS-734016) Monotherapy in Subjects With Melanoma Brain Metastases
For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.
Inclusion Criteria:
- Malignant melanoma with measurable brain metastases
- At least one measurable index metastatic brain lesion, with its greatest dimension >
0.5 cm and no larger than 3 cm in diameter, that has not been previously irradiated,
and/or at least 2 measurable lesions > 0.3 cm that are visible on contrast-enhanced
MRI
- ECOG 0-1
- Stable labs
- Age >/= 16 years
Exclusion
- Auto immune disease, Hepatitis or HIV, other cancer
- Previous treatment with other CTLA-4 agonists, or concurrent IL-2 therapy
- Major surgery within 28 days
- Prior stereotactic or highly conformal radiotherapy and/or whole brain irradiation
within 14 days prior to start of ipilimumab dosing for this study
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tumor assessment
Outcome Time Frame:
after 12 weeks of first dose and then every 6 weeks
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA184-042
NCT ID:
NCT00623766
Start Date:
July 2008
Completion Date:
October 2012
Related Keywords:
- Melanoma
- Melanoma
- Neoplasm Metastasis
Name | Location |
|---|---|
| Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
| Loyola University Medical Center | Maywood, Illinois 60153 |
| Seattle Cancer Care Alliance | Seattle, Washington 98109 |
| City of Hope | Duarte, California 91010 |
| Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
| The Angeles Clinic & Research Institute | Los Angeles, California 90404 |
| Local Institution | Bronx, New York |
| Oncology Specialists, S.C. | Park Ridge, Illinois 60068 |
| Yale University School Of Medicine | New Haven, Connecticut 06520 |
| Mayo Clinic Arizona | Scottsdale, Arizona 85259 |
| Vanderbilt-Ingram Cancer Ctr | Nashville, Tennessee 37232 |
| Providence Portland Med Ctr | Portland, Oregon 97213 |
