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

Primary Purpose

Stage III or IV Melanoma

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

BMS-936559 (Anti-PD-L1)

About this trial

This is an interventional basic science trial for Stage III or IV Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

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

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

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

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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

Full Information

NCT ID

NCT01455103

First Posted

October 18, 2011

Last Updated

December 12, 2011

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT01455103

Brief Title

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

Acronym

PD-L1

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Withdrawn

Study Start Date

November 2011 (undefined)

Primary Completion Date

November 2013 (Anticipated)

Study Completion Date

November 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stage III or IV Melanoma

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Title

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

Arm Type

Experimental

Arm Title

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

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

BMS-936559 (Anti-PD-L1)

Other Intervention Name(s)

MDX1105

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

BMS-936559 (Anti-PD-L1)

Other Intervention Name(s)

MDX1105

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

BMS-936559 (Anti-PD-L1)

Other Intervention Name(s)

MDX1105

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

Baseline and within the first 24 weeks of study participation

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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