Study of BMS-986158 in Subjects With Select Advanced Cancers

NCT ID: NCT02419417

Last Updated: 2022-06-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-19

Study Completion Date

2021-03-17

Brief Summary

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The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986158 in subjects with select advanced cancers

Detailed Description

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Conditions

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Advanced Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Monotherapy Treatment

Patients treated at various doses and schedules

Group Type EXPERIMENTAL

BMS-986158

Intervention Type DRUG

Specified dose on specified days

Combination Therapy

Patients treated at selected doses and schdules

Group Type EXPERIMENTAL

BMS-986158

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Interventions

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BMS-986158

Specified dose on specified days

Intervention Type DRUG

Nivolumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Other Intervention Names

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BMS-936558 Opdivo

Eligibility Criteria

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Inclusion Criteria

* Must have select advanced cancers with specific genetic profiles
* Must have received appropriate standard of care
* At least one measurable lesion at baseline
* Expected to have life expectancy of at least 3 months
* Eastern Cooperative Oncology Group (ECOG) of 0 to 1

Exclusion Criteria

* Concomitant second malignancies
* Uncontrolled or significant cardiovascular disease
* Inadequate bone marrow function
* Chronic gastrointestinal illness
* Prior treatment with Bromodomain and Extra-Terminal (BET) inhibitor
Minimum Eligible Age

12 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

Locations

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City Of Hope National Medical Center

Duarte, California, United States

Site Status

University Of Colorado

Aurora, Colorado, United States

Site Status

Dana Farber Cancer Institute.

Boston, Massachusetts, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

Univ. Of Pa

Philadelphia, Pennsylvania, United States

Site Status

Institute for Translational Oncology Research-ITOR

Greenville, South Carolina, United States

Site Status

Nucleus Network

Melbourne, Victoria, Australia

Site Status

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Site Status

Local Institution

Lyon, , France

Site Status

Local Institution

Villejuif, , France

Site Status

H. Univ. Vall dHebron

Barcelona, , Spain

Site Status

Centro Integral Oncologico Clara Campal

Madrid, , Spain

Site Status

Clinica Universidad de Navarra

Pamplona, , Spain

Site Status

Countries

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United States Australia Canada France Spain

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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2015-000324-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA011-001

Identifier Type: -

Identifier Source: org_study_id

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