Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2018-03-06
2019-07-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Monotherapy
administering nivolumab only
Nivolumab
specified dose on specified days
Interventions
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Nivolumab
specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
* Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to randomization
Exclusion Criteria
* Participants with carcinomatous meningitis
* Participants with active, known or suspected autoimmune disease
* Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
* Other active malignancy requiring concurrent intervention
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
Bangalore, , India
Local Institution
Bangalore, , India
Local Institution
Bengaluru, , India
Local Institution
Hyderabad, , India
Local Institution
Jaipur, , India
Local Institution
Kolkata, , India
Local Institution
Mumbai, , India
Local Institution
New Delhi, , India
Local Institution
Vellore, , India
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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CA209-887
Identifier Type: -
Identifier Source: org_study_id