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A Phase I Study of the Biologic Effects of BMS-936559 Treatment in Subjects With Unresectable Stage III or IV Melanoma

Phase 1
18 Years
Not Enrolling
Stage III or IV Melanoma

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Trial Information

A Phase I Study of the Biologic Effects of BMS-936559 Treatment in Subjects With Unresectable Stage III or IV Melanoma

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 Programmed cell death 1 (PD-1), anti Programmed
cell death ligand 1 (anti-PD-L1), anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40 or
anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibodies

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Evidence of immunomodulatory effects of BMS-936559 as measured by changes from baseline in biomarkers assessed 1) peripheral blood assays including flow cytometry and soluble factors and 2) tumor based assays including immunohistochemistry

Outcome Time Frame:

Baseline and within the first 24 weeks of study participation

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:

November 2011

Completion Date:

November 2013

Related Keywords:

  • Stage III or IV Melanoma
  • Melanoma