A Study of the Safety and Tolerability of BMS-986183 in Patients With Liver Cancer
NCT ID: NCT02828124
Last Updated: 2019-01-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
25 participants
INTERVENTIONAL
2016-08-23
2018-01-08
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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Dose Escalation Monotherapy
BMS-986183
specified dose on specified days
Dose Expansion Monotherapy
BMS-986183
specified dose on specified days
Dose Escalation Combination Therapy
BMS-986183
specified dose on specified days
Nivolumab
specified dose on specified days
Dose Expansion Combination Therapy
BMS-986183
specified dose on specified days
Nivolumab
specified dose on specified days
Interventions
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BMS-986183
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
* Liver cancer is confirmed by a microscopic examination of tissue
* Liver disease is classified as 'A' by a standard method called Child-Pugh score
* Daily living abilities are classified as '0 or 1' by a standard method from the Eastern Cooperative Oncology Group (ECOG)
* Women must use contraception
Exclusion Criteria
* Increase in blood pressure in some of the veins entering the liver
* Cancer that has spread to the brain or the layers of tissue that cover the brain or spinal cord
* Infection with both hepatitis B and C, both hepatitis D and B, infection with HIV, or other infections
* Disease of the heart or blood vessels around the heart
* Active cancers within the last 2 years
* No more than 2 prior systemic treatments or other investigational agents except PD-1/PD-L1 or Ipilimumab (Part 2)
* Currently on anti-platelet or anti-coagulation therapy
* Radiotherapy within 4 weeks of treatment
* Any major allergies
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
Ottawa, Ontario, Canada
Local Institution
Singapore, , Singapore
Local Institution
Seoul, , South Korea
Local Institution
Taipei, , Taiwan
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 Patient Recruiting
Investigator Inquiry Form
Other Identifiers
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CA015-003
Identifier Type: -
Identifier Source: org_study_id
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