An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab

NCT ID: NCT02754141

Last Updated: 2023-04-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-21

Study Completion Date

2021-10-12

Brief Summary

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The purpose of this study is to assess the safety and tumor-shrinking ability of experimental medication BMS-986179 alone and when combined with Nivolumab, in patients with solid cancers that are advanced or have spread.

Detailed Description

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Conditions

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Malignant Solid Tumor

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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Arm A-Monotherapy

BMS-986179, dose as specified

Group Type EXPERIMENTAL

BMS-986179

Intervention Type BIOLOGICAL

Specified dose on specified days

Arm B- Combination Therapy

BMS-986179 + nivolumab, dose as specified

Group Type EXPERIMENTAL

BMS-986179

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Arm C-Combination Therapy

BMS-986179 + rHuPH20, dose as specified

Group Type EXPERIMENTAL

BMS-986179

Intervention Type BIOLOGICAL

Specified dose on specified days

rHuPH20

Intervention Type BIOLOGICAL

Specified dose on specified days

Interventions

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BMS-986179

Specified dose on specified days

Intervention Type BIOLOGICAL

Nivolumab

Specified dose on specified days

Intervention Type BIOLOGICAL

rHuPH20

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

* Solid cancers that are advanced or have spread (for which alternative therapies were deemed not effective)
* Eastern Cooperative Oncology Group (ECOG) 0-1
* Acceptable lab testing results
* Allow biopsies

Exclusion Criteria

* Central nervous system (CNS) tumors
* Uncontrolled or significant cardiovascular diseases
* Active or known autoimmune disease
* Organ transplant
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

Locations

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Local Institution - 0028

Chicago, Illinois, United States

Site Status

Local Institution - 0001

Baltimore, Maryland, United States

Site Status

Local Institution - 0022

Boston, Massachusetts, United States

Site Status

Local Institution - 0023

Buffalo, New York, United States

Site Status

Local Institution - 0005

New York, New York, United States

Site Status

Local Institution - 0020

Pittsburgh, Pennsylvania, United States

Site Status

Local Institution - 0004

Nashville, Tennessee, United States

Site Status

Local Institution - 0009

Dallas, Texas, United States

Site Status

Local Institution - 0019

Randwick, New South Wales, Australia

Site Status

Local Institution - 0017

Sydney, New South Wales, Australia

Site Status

Local Institution - 0018

Melbourne, Victoria, Australia

Site Status

Local Institution - 0003

Ottawa, Ontario, Canada

Site Status

Local Institution - 0002

Toronto, Ontario, Canada

Site Status

Local Institution - 0024

Montreal, Quebec, Canada

Site Status

Local Institution - 0014

Montreal, Quebec, Canada

Site Status

Local Institution - 0033

Marseille, , France

Site Status

Local Institution - 0021

Marseille, , France

Site Status

Local Institution - 0008

Toulouse, , France

Site Status

Local Institution - 0007

Villejuif, , France

Site Status

Local Institution - 0016

Freiburg im Breisgau, , Germany

Site Status

Local Institution - 0015

Munich, , Germany

Site Status

Local Institution - 0012

Napoli, , Italy

Site Status

Local Institution - 0013

Padua, , Italy

Site Status

Local Institution - 0006

Amsterdam, , Netherlands

Site Status

Countries

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United States Australia Canada France Germany Italy Netherlands

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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2016-000603-91

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA013-004

Identifier Type: -

Identifier Source: org_study_id

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