Status:
WITHDRAWN
Phase 1 Biomarker Study of Anti-PDL-1 in Advanced Melanoma
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Stage III or IV Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate pharmacodynamic changes of BMS-936559 treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with unresectable Stage III or...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01455103
Start Date
November 1 2011
End Date
November 1 2013
Last Update
December 13 2011
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