A Study of an Anti-KIR Antibody Lirilumab in Combination With an Anti-PD1 Antibody Nivolumab and Nivolumab Plus an Anti-CTLA-4 Ipilimumab Antibody in Patients With Advanced Solid Tumors
NCT ID: NCT01714739
Last Updated: 2023-02-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
337 participants
INTERVENTIONAL
2012-10-07
2019-12-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Part 1
Dose Escalation and Initial Signal Detection in Multiple Solid Tumors - Nivolumab with Lirilumab
Lirilumab
Specified dose on specified days.
Nivolumab
Specified dose on specified days.
Part 2 and 3: Cohort Expansion
In platinum-refractory recurrent or metastatic SCCHN - Nivolumab with or without Lirilumab
Lirilumab
Specified dose on specified days.
Nivolumab
Specified dose on specified days.
Part 4: Cohort Expansion
Additional Signal Detection in Solid Tumors - Nivolumab with Lirilumab (Study Part 4 Removed; No Subjects Enrolled)
Lirilumab
Specified dose on specified days.
Nivolumab
Specified dose on specified days.
Part 5 and 6
Safety Lead-In and Additional Signal Detection in Solid Tumors -- Nivolumab Plus Ipilimumab with Lirilumab (Study Part 6 Removed; No Subjects Enrolled)
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
* During cohort expansion, subjects with various solid tumors that have received at least one and no more than 5 prior treatment regimens
* Subjects must have measurable disease
* Subject must consent to provide previously collected tumor tissue
* Women and men ≥18 years of age with performance status of 0 or 1
* At least 4 weeks since any previous treatment for cancer
Exclusion Criteria
* Uncontrolled or significant cardiovascular disease
* Chronic hepatitis (except for subjects with hepatocellular carcinoma)
* Active infection
* Active Central nervous system (CNS) metastases
* Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome((HIV/AIDS)
* Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma)
18 Years
ALL
No
Sponsors
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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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Ucsf
San Francisco, California, United States
Florida Cancer Affiliates - Ocala
Ocala, Florida, United States
University Of Chicago Medical Center
Chicago, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Lutherville, Maryland, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Providence Portland Med Ctr
Portland, Oregon, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
UPMC Eye and Ear Institute
Pittsburgh, Pennsylvania, United States
West Cancer Center
Germantown, Tennessee, United States
Texas Oncology-Central Austin Cancer Center
Austin, Texas, United States
University Of Texas Medical Branch Of Galveston
Galveston, Texas, United States
University Of Washington
Seattle, Washington, United States
Juravinski Cancer Center
Hamilton, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Local Institution
Bordeaux, , France
Local Institution
Lyon, , France
Local Institution
Nice, , France
Local Institution
Paris, , France
Institut Gustave Roussy
Villejuif, , France
IRCCS Istituto Nazionale Tumori Milano
Milan, MI, Italy
Local Institution
Siena, , Italy
Local Institution
Barcelona, , Spain
Local Institution - 0038
Madrid, , Spain
Local Institution
Madrid, , Spain
Kantonsspital Graubuenden
Chur, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
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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CA223-001
Identifier Type: -
Identifier Source: org_study_id
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