A Safety Study of Lirilumab in Combination With Nivolumab or in Combination With Nivolumab and Ipilimumab in Advanced and/or Metastatic Solid Tumors
NCT ID: NCT03203876
Last Updated: 2022-03-10
Study Results
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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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2017-07-14
2020-08-06
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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Part One Combination Therapy
Lirilumab and Nivolumab
Lirilumab
Specified dose on specified days
Nivolumab
Specified dose on specified days
Part 2 Combination Therapy
Lirilumab, Nivolumab and Ipilimumab
Lirilumab
Specified dose on specified days
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Interventions
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Lirilumab
Specified dose on specified days
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must have histologic or cytologic confirmation of a solid malignancy that is advanced (metastatic and/or unresectable)
* Presence of at least 1 lesion with measurable disease as defined by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) criteria for response assessment
* The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria
* Participants with an active, known, or suspected autoimmune disease
* Uncontrolled or significant cardiovascular disease
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
Kashiwa-shi, Chiba, Japan
Local Institution
Kobe, Hyōgo, Japan
Countries
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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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CA223-030
Identifier Type: -
Identifier Source: org_study_id
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