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

Phase 1

Withdrawn

• Conditions: Stage III or IV Melanoma
• Interventions: Biological: BMS-936559 (Anti-PD-L1)

• Registration Number: NCT01455103
• Lead Sponsor: Bristol-Myers Squibb

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 IV Melanoma.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-10
• Study First Submitted: 2011-10-18
• Study First Submitted QC: 2011-10-18
• Study First Posted: 2011-10-19
• Study Start: 2011-11
• Last Update Submitted: 2011-12-12
• Last Update Posted: 2011-12-13
• Primary Completion: 2013-11
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: BMS-936559 (1mg/kg)	BMS-936559 (Anti-PD-L1)	-
Arm 2: BMS-936559 (3mg/kg)	BMS-936559 (Anti-PD-L1)	-
Arm 3: BMS-936559 (10mg/kg)	BMS-936559 (Anti-PD-L1)	-

Primary Outcome Measures

Name	Time	Method
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	Baseline and within the first 24 weeks of study participation

Secondary Outcome Measures

Name	Time	Method
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	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	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	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	Predose (screening) and Cycle 3 Day 1