An Investigational Immuno-Therapy Study of Experimental Medication BMS-986242 Given in Combination With Nivolumab in Patients With Advanced Cancer

NCT ID: NCT03351231

Last Updated: 2020-08-26

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

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-27

Study Completion Date

2018-08-28

Brief Summary

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The purpose of this study is to investigate safety of experimental medication BMS-986242 and Nivolumab in patients with advanced cancers.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation

BMS-986242 administered in combination with Nivolumab

Group Type EXPERIMENTAL

BMS-986242

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Dose Expansion

BMS-986242 administered in combination with Nivolumab

Group Type EXPERIMENTAL

BMS-986242

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Interventions

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BMS-986242

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 Anti-PD-1

Eligibility Criteria

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Inclusion Criteria

* Histologic or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease per RECIST v1.1
* Participants must have received and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting if such a therapy exists
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Ability to swallow tablets
* Adequate bone marrow and organ function, as defined by the protocol

Exclusion Criteria

* Participants with known or suspected CNS metastases, untreated CNS metastases, or with the CNS as the only site of disease (patients with controlled brain metastasis allowed to enroll)
* Ocular melanoma
* Any significant acute or chronic medical illness
* Prior malignancy
* Other active malignancy requiring concurrent intervention
* Prior organ allograft or allogeneic bone marrow transplantation
* Participants with active, known, or suspected autoimmune disease
* Requirement for daily supplemental oxygen
* Uncontrolled or significant cardiovascular disease
* Pre-existing liver disease
* Gastrointestinal disease known to interfere with absorption
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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University Of Alabama At Birmingham

Birmingham, Alabama, United States

Site Status

Hoag Memorial Hospital Presbyterian

Los Angeles, California, United States

Site Status

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Local Institution

Baltimore, Maryland, United States

Site Status

Countries

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United States

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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2017-003603-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA024-001

Identifier Type: -

Identifier Source: org_study_id

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