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

Bristol-Myers Squibb

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Conditions

Stage III or IV Melanoma

Interventions

BMS-936559 (Anti-PD-L1)BIOLOGICAL

Solution, Intravenous infusion, 1 mg/kg, Every 2 weeks, Up to 2 years, depending on response

BMS-936559 (Anti-PD-L1)BIOLOGICAL

Solution, Intravenous infusion, 3 mg/kg, Every 2 weeks, Up to 2 years, depending on response

BMS-936559 (Anti-PD-L1)BIOLOGICAL

Solution, Intravenous infusion, 10 mg/kg, Every 2 weeks, Up to 2 years, depending on response

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Evidence of immunomodulatory effects of BMS-936559 as measured by changes from baseline in biomarkers assessed 1) peripheral blood assays including flow cytometry and soluble factors and 2) tumor based assays including immunohistochemistry

Time frame: Baseline and within the first 24 weeks of study participation

Secondary Outcomes

Safety and tolerability of BMS-936559 as measured by the incidence of adverse events (AEs), serious AEs, laboratory test abnormalities, and changes in vital signs

Time frame: Every 2 weeks until 70 days after last treatment

Antitumor Activity of BMS-936559 as measured by the objective response rate, disease control rate, duration of response, and progression free survival

Time frame: Every 6 weeks for 1 year, every 12 weeks thereafter until confirmed disease progression

Immunogenicity of BMS-936559 as measured by the frequency of subjects with an increase in anti-drug antibody levels from baseline

Time frame: Baseline, Week 6, Week 12, and then every 12 weeks until follow-up

Pharmacodynamic activity of BMS-936559 as measured by changes from baseline of the tetramer assay in HLA-A*0210 positive subject only

Time frame: Predose (screening) and Cycle 3 Day 1

Data from ClinicalTrials.gov

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