Phase 1 Biomarker Study of Anti-PDL-1 in Advanced Melanoma (PD-L1)

December 12, 2011 updated by: Bristol-Myers Squibb

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1: BMS-936559 (1mg/kg)
Biological: BMS-936559 (Anti-PD-L1)
Solution, Intravenous infusion, 1 mg/kg, Every 2 weeks, Up to 2 years, depending on response
Other Names:
  • MDX1105
Biological: BMS-936559 (Anti-PD-L1)
Solution, Intravenous infusion, 3 mg/kg, Every 2 weeks, Up to 2 years, depending on response
Other Names:
  • MDX1105
Biological: BMS-936559 (Anti-PD-L1)
Solution, Intravenous infusion, 10 mg/kg, Every 2 weeks, Up to 2 years, depending on response
Other Names:
  • MDX1105
EXPERIMENTAL: Arm 2: BMS-936559 (3mg/kg)
Biological: BMS-936559 (Anti-PD-L1)
Solution, Intravenous infusion, 1 mg/kg, Every 2 weeks, Up to 2 years, depending on response
Other Names:
  • MDX1105
Biological: BMS-936559 (Anti-PD-L1)
Solution, Intravenous infusion, 3 mg/kg, Every 2 weeks, Up to 2 years, depending on response
Other Names:
  • MDX1105
Biological: BMS-936559 (Anti-PD-L1)
Solution, Intravenous infusion, 10 mg/kg, Every 2 weeks, Up to 2 years, depending on response
Other Names:
  • MDX1105
EXPERIMENTAL: Arm 3: BMS-936559 (10mg/kg)
Biological: BMS-936559 (Anti-PD-L1)
Solution, Intravenous infusion, 1 mg/kg, Every 2 weeks, Up to 2 years, depending on response
Other Names:
  • MDX1105
Biological: BMS-936559 (Anti-PD-L1)
Solution, Intravenous infusion, 3 mg/kg, Every 2 weeks, Up to 2 years, depending on response
Other Names:
  • MDX1105
Biological: BMS-936559 (Anti-PD-L1)
Solution, Intravenous infusion, 10 mg/kg, Every 2 weeks, Up to 2 years, depending on response
Other Names:
  • MDX1105

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline and within the first 24 weeks of study participation

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
Predose (screening) and Cycle 3 Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ANTICIPATED)

November 1, 2013

Study Completion (ANTICIPATED)

November 1, 2013

Study Registration Dates

First Submitted

October 18, 2011

First Submitted That Met QC Criteria

October 18, 2011

First Posted (ESTIMATE)

October 19, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 13, 2011

Last Update Submitted That Met QC Criteria

December 12, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA210-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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