A Study of BMS-986205 Given in Combination With Nivolumab in Patients With Advanced Tumors

NCT ID: NCT03192943

Last Updated: 2019-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-23

Study Completion Date

2018-12-11

Brief Summary

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The purpose of this study is to assess the safety and tolerability for the combination therapy of BMS-986205 and Nivolumab in patients with advanced tumors

Detailed Description

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Conditions

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Advanced Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation

monotherapy and combination therapy

Group Type EXPERIMENTAL

BMS-986205

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified day

Interventions

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BMS-986205

Specified dose on specified days

Intervention Type DRUG

Nivolumab

Specified dose on specified day

Intervention Type BIOLOGICAL

Other Intervention Names

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Opdivo BMS-936558

Eligibility Criteria

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Inclusion Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

* Participants must have histologic or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease per Response Evaluation Criteria In Solid Tumors (RECIST v1.1)
* Participants must have received, and then progressed or been intolerant to standard treatment regimen in the advanced or metastatic setting
* Eastern Cooperative Oncology Group performance status of ≤ 1

Exclusion Criteria

* Participants with known or suspected CNS metastases, untreated CNS metastases, or with the CNS as the only site of disease are excluded
* History of congenital or autoimmune hemolytic disorders
* History or presence of hypersensitivity or idiosyncratic reaction to methylene blue
Minimum Eligible Age

20 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

Chuo-ku, Tokyo, Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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CA017-048

Identifier Type: -

Identifier Source: org_study_id

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