Phase 1 Biomarker Study of Anti-PD-1 in Advanced Melanoma

Status: Recruiting
Phase: Phase 1
Diagnosis: Cutaneous Skin Cancer
NCT ID: NCT01621490 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-423

 

The purpose of this study is to evaluate pharmacodynamic changes of BMS-936558 treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with advanced melanoma (unresectable or advanced).

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital, Beth-Israel Deaconess Medical Center

Overall PI:
Frank Stephen Hodi, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Donald Lawrence, MD, Massachusetts General Hospital
David McDermott, MD, Beth Israel Deaconess Medical Center

Contacts:
Dana-Farber Cancer Institute: Suzanne MacRae, 617-632-5906, smacrae@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

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
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