A Safety Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Non-small Cell Lung Cancer
NCT ID: NCT03048136
Last Updated: 2018-04-17
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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WITHDRAWN
PHASE3
INTERVENTIONAL
2018-03-09
2019-09-29
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
NONE
Study Groups
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Flat-Dose
Nivolumab flat dose + Ipilimumab
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Weight-Based Dose
Nivolumab weight-based dose + Ipilimumab
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Interventions
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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
* 2\) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
* 3\) Prior adjuvant or neoadjuvant chemotherapy for local, advanced disease allowed if completed at least 6 months prior to randomization
Exclusion Criteria
* 2\) Active, known or suspected autoimmune disease or HIV infection
* 3\) Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
* 4\) Untreated Central Nervous System metastases
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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Local Institution
San Francisco, California, United States
Local Institution
Lincoln, Nebraska, United States
Local Institution
Hackensack, New Jersey, United States
Local Institution
Columbus, Ohio, United States
Local Institution
Lancaster, Pennsylvania, United States
Local Institution
Langhorne, Pennsylvania, United States
Local Institution
Sayre, Pennsylvania, United States
Local Institution
Charleston, South Carolina, United States
Local Institution
St. George, Utah, United States
Local Institution
Viedma, Río Negro Province, Argentina
Local Institution
Montreal, Quebec, Canada
Local Institution
Dresden, , Germany
Local Institution
Gauting, , Germany
Local Institution
Gerlingen, , Germany
Local Institution
Großhansdorf, , Germany
Local Institution
Lima, , Peru
Local Institution
Lima, , Peru
Countries
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Related Links
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BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
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CA209-955
Identifier Type: -
Identifier Source: org_study_id
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