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