A Study of BMS-986205 Alone and in Combination With Nivolumab in Chinese Patients With Advanced Malignant Solid Tumors

NCT ID: NCT03792750

Last Updated: 2022-02-28

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-31

Study Completion Date

2020-12-18

Brief Summary

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The purpose of this study is to determine safety and effectiveness of experimental medication BMS-986205 in combination with Nivolumab in patients with cancers that are advanced or have spread.

Detailed Description

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Conditions

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Advanced Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental Arm A

2 week BMS-986205 monotherapy lead in followed by BMS-986205 + Nivo combination therapy

Group Type EXPERIMENTAL

BMS-986205

Intervention Type DRUG

Specified Dose on Specified Day

Nivolumab

Intervention Type BIOLOGICAL

Specified Dose on Specified Day

Interventions

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BMS-986205

Specified Dose on Specified Day

Intervention Type DRUG

Nivolumab

Specified Dose on Specified Day

Intervention Type BIOLOGICAL

Other Intervention Names

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BMS-936558

Eligibility Criteria

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Inclusion Criteria

* Participants must have histologic or cytological confirmation of a solid tumor that is advanced with measureable disease per RECIST v1.1
* Participants must have received, and then progressed or been intolerant to at least one standard treatment regimen in the advanced or metastatic setting
* Participants must have an ECOG performance status of less than or equal to 1
* Participants must have at least 1 lesion with measurable disease as defined by RECIST Version 1.1

Exclusion Criteria

* Participants must not have suspected, known, or progressive CNS metastases, have untreated CNS metastases, or have the CNS as the only site of disease
* Participants with prior exposure to anti PD-1 or anti-PDL1 therapy
* Participants must not have a history of allergy to any of the study treatment components
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

Hangzhou, Zhejiang, China

Site Status

Countries

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China

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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CA017-076

Identifier Type: -

Identifier Source: org_study_id

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