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

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

NCT01455103•Bristol-Myers Squibb

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 IV Melanoma.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

November 1, 2011

Primary Completion Date

November 1, 2013

Completion Date

November 1, 2013

Last Updated

December 13, 2011

Conditions

Stage III or IV Melanoma

Interventions

BMS-936559 (Anti-PD-L1)

BIOLOGICAL

BMS-936559 (Anti-PD-L1)

BIOLOGICAL

BMS-936559 (Anti-PD-L1)

BIOLOGICAL

Ipilimumab and Dabrafenib in the 1st Line Tx of Unresectable Stage III/IV Melanoma

NCT02200562

Stage III or IV Melanoma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 13, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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