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A Multi-Center Phase II Study to Evaluate Tumor Response to Ipilimumab (BMS-734016) Monotherapy in Subjects With Melanoma Brain Metastases

Phase 2
16 Years
Not Enrolling

Thank you

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 Please visit 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

- ECOG 0-1

- Stable labs

- Age >/= 16 years


- 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:


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:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

July 2008

Completion Date:

October 2012

Related Keywords:

  • Melanoma
  • Melanoma
  • Neoplasm Metastasis



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