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

NCT ID: NCT01455103

Last Updated: 2011-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-11-30

Brief Summary

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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

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Conditions

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Stage III or IV Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Arm 1: BMS-936559 (1mg/kg)

Group Type EXPERIMENTAL

BMS-936559 (Anti-PD-L1)

Intervention Type BIOLOGICAL

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

Arm 2: BMS-936559 (3mg/kg)

Group Type EXPERIMENTAL

BMS-936559 (Anti-PD-L1)

Intervention Type BIOLOGICAL

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

Arm 3: BMS-936559 (10mg/kg)

Group Type EXPERIMENTAL

BMS-936559 (Anti-PD-L1)

Intervention Type BIOLOGICAL

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

Interventions

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BMS-936559 (Anti-PD-L1)

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

Intervention Type BIOLOGICAL

BMS-936559 (Anti-PD-L1)

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

Intervention Type BIOLOGICAL

BMS-936559 (Anti-PD-L1)

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

Intervention Type BIOLOGICAL

Other Intervention Names

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MDX1105 MDX1105 MDX1105

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Other Identifiers

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CA210-002

Identifier Type: -

Identifier Source: org_study_id