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A Study of Cabiralzumab Given by Itself or With Nivolumab in Advanced Cancer or Cancer That Has Spread

NCT ID: NCT03158272

Last Updated: 2020-12-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-25

Study Completion Date

2019-10-23

Brief Summary

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The purpose of this study is to determine whether an investigational immuno-therapy, cabiralizumab in combination with nivolumab, is safe and tolerable in the treatment of advanced malignancies.

Detailed Description

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Conditions

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Advanced Malignancies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment will only in combination therapy arm.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Monotherapy

Cabiralizumab administered as a single agent intravenous formulation

Group Type EXPERIMENTAL

Cabiralizumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Combination Therapy

Cabiralizumab will be administered in combination with Nivolumab as an intravenous formulation

Group Type EXPERIMENTAL

Cabiralizumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Interventions

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Cabiralizumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Nivolumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Other Intervention Names

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Opdivo

Eligibility Criteria

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Inclusion Criteria

* Performance status 0-1
* Adequate organ function
* Cohort M1, 2 and C1: Measurable disease
* Cohort M1, M2 and C1: Subjects must have histologic or cytologic confirmation of an advanced (metastatic and/or unresectable) malignant solid tumor
* Cohort C2: Documented refractory or relapsed multiple myeloma
* Subjects must be refractory to or have relapsed after standard therapies, or have no known effective treatment

Exclusion Criteria

* Cohort M1, M2, and C1: Untreated or active central nervous system (CNS) or leptomeningeal metastases
* Cohort M1, M2, and C1: Subjects with hepatocellular carcinoma (HCC)
* Cohort C2: Subjects with solitary bone or extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role collaborator

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

Nagoya, Aichi-ken, Japan

Site Status

Local Institution

Kamogawa-shi, Chiba, Japan

Site Status

Local Institution

Kashiwa-shi, Chiba, Japan

Site Status

Local Institution

Chuo-ku, Tokyo, Japan

Site Status

Countries

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Japan

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html

Investigator Inquiry Form

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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CA025-001

Identifier Type: -

Identifier Source: org_study_id