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
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View full resultsBasic Information
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COMPLETED
PHASE1
19 participants
INTERVENTIONAL
2017-05-25
2019-10-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Monotherapy
Cabiralizumab administered as a single agent intravenous formulation
Cabiralizumab
Specified dose on specified days
Combination Therapy
Cabiralizumab will be administered in combination with Nivolumab as an intravenous formulation
Cabiralizumab
Specified dose on specified days
Nivolumab
Specified dose on specified days
Interventions
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Cabiralizumab
Specified dose on specified days
Nivolumab
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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: Subjects with hepatocellular carcinoma (HCC)
* Cohort C2: Subjects with solitary bone or extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
20 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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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
Local Institution
Kamogawa-shi, Chiba, Japan
Local Institution
Kashiwa-shi, Chiba, Japan
Local Institution
Chuo-ku, Tokyo, Japan
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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CA025-001
Identifier Type: -
Identifier Source: org_study_id
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