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 MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com 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
therapy