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An Exploratory Study of the Biologic Effects of BMS-936558 (Anti-PD-1 Monoclonal Antibody) Treatment in Subjects With Advanced Melanoma (Unresectable or Metastatic)

Phase 1
18 Years
Open (Enrolling)
Advanced Melanoma, Metastatic Melanoma

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Trial Information

An Exploratory Study of the Biologic Effects of BMS-936558 (Anti-PD-1 Monoclonal Antibody) Treatment in Subjects With Advanced Melanoma (Unresectable or Metastatic)

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:

- Men and women > 18 years

- Eastern Cooperative Oncology Group (ECOG) status = 0 to 1

- Subjects with unresectable Stage III or IV melanoma who are either refractory or
intolerant to, or have refused standard therapy for treatment of metastatic melanoma

- Subject must have histologic or cytologic confirmation of advanced melanoma

- Subjects must have at least one measurable lesion at baseline by computed tomography
(CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid
Tumors (RECIST) 1.1 criteria

- Subjects must have at least 1 tumor site that can be biopsied at acceptable clinical
risk and must consent to pre- and post-treatment biopsies

Exclusion Criteria:

- Active or progressing brain metastases

- Other concomitant malignancies (with some exceptions per protocol)

- Active or history of autoimmune disease

- Positive test for human immunodeficiency virus (HIV) 1&2 or known acquired
immunodeficiency syndrome (AIDS)

- History of any hepatitis

- Prior therapy with any antibody/drug that targets the T cell coregulatory proteins,
including but not limited to, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137,
anti-OX-40,and anti-CD40 antibodies. However, half the patients must have progressed
on anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA4) monoclonal antibody

Type of Study:


Study Design:

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Immunomodulatory effects of BMS-936558 as measured by changes from baseline in activated and memory T cells, interferon, interferon inducible factors, and CD4 and CD8 T cell infiltration

Outcome Time Frame:

Pre-dose day 1

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:

October 2012

Completion Date:

January 2016

Related Keywords:

  • Advanced Melanoma
  • Metastatic Melanoma
  • Melanoma



Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Seattle Cancer Care AllianceSeattle, Washington  98109
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Providence Portland Medical CenterPortland, Oregon  97213-3635
University of ChicagoChicago, Illinois  60637
Memorial Sloan Kettering Cancer CtrNew York, New York  10021
The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Virginia Health SystemCharlottesville, Virginia  22903
Vanderbilt-Ingram Cancer CtrNashville, Tennessee  37232