An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma
NCT ID: NCT03329846
Last Updated: 2021-07-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
20 participants
INTERVENTIONAL
2017-11-30
2020-07-02
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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Nivolumab + Placebo
Specified dose on specified day
Participants will no longer receive BMS-986205 Placebo
Nivolumab
Specified dose on specified day
Placebo
Specified dose on specified day
Nivolumab + BMS-986205
Specified dose on specified day.
Participants have the option to discontinue BMS-986205, and continue nivolumab monotherapy, at investigator discretion
BMS-986205
specified dose on specified day
Nivolumab
Specified dose on specified day
Interventions
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BMS-986205
specified dose on specified day
Nivolumab
Specified dose on specified day
Placebo
Specified dose on specified day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1
* Histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the American Joint Committee on Cancer (AJCC) Staging Manual (8th edition)
* Treatment-naïve participants (no prior systemic anticancer therapy for unresectable or metastatic melanoma)
* Measurable disease per RECIST v1.1
Exclusion Criteria
* Uveal or ocular melanoma
* Participants with active, known, or suspected autoimmune disease
* Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
12 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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Angeles Clinic and Research Institute
Los Angeles, California, United States
University Of Colorado
Aurora, Colorado, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
University Of Chicago
Chicago, Illinois, United States
Oregon Health & Science University
Portland, Oregon, United States
Local Institution
Seattle, Washington, United States
Local Institution
Blacktown, New South Wales, Australia
Melanoma Institute Australia
North Sydney, New South Wales, Australia
Local Institution
Greenslopes, Queensland, Australia
Local Institution
Woolloongabba, Queensland, Australia
Local Institution
Box Hill, Victoria, Australia
Local Institution
Melbourne, Victoria, Australia
Local Institution
Melbourne, Victoria, Australia
Local Institution
Montreal, Quebec, Canada
Local Institution
Québec, Quebec, Canada
Klinika onkologie a radioterapie
Hradec Králové, , Czechia
Dermatovenerologicka klinika 3. LF UK a FNKV
Prague, , Czechia
Dermatovenerologicka klinika VFN a 1. LF UK
Prague, , Czechia
Local Institution
Boulogne-Billancourt, , France
Local Institution
Saint-Etienne, , France
Local Institution
Villejuif, , France
Elbe Klinikum Buxtehude
Buxtehude, , Germany
Universitaetsklinikum Carl Gustav Carus
Dresden, , Germany
Local Institution
Essen, , Germany
SRH Wald-Kliniken Gera GmbH
Gera, , Germany
Georg August Universitaet Goettingen
Göttingen, , Germany
Local Institution
Hanover, , Germany
Local Institution
Heidelberg, , Germany
Local Institution
München, , Germany
Local Institution
Tübingen, , Germany
Interbalkan European Medical Center
Thessaloniki, , Greece
Local Institution
Dooradoyle, Limerick, Ireland
Local Institution
Dublin, , Ireland
Local Institution
Dublin, , Ireland
Local Institution
Milan, , Italy
Istituto Nazionale Tumori Fondazione Pascale
Napoli, , Italy
Azienda Ospedaliera Universitaria Senese
Siena, , Italy
Local Institution
Sendai, Miyagi, Japan
Local Institution
Niigata, Niigata, Japan
Local Institution
Okayama, Okayama-ken, Japan
Local Institution
Osaka, Osaka, Japan
Local Institution
Chuo-ku, Tokyo, Japan
Local Institution
Amsterdam, , Netherlands
Local Institution
Groningen, , Netherlands
Local Institution
Nijmegen, , Netherlands
Local Institution
Rotterdam, , Netherlands
Local Institution
Christchurch, , New Zealand
Local Institution
Wellington, , New Zealand
Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
Warsaw, , Poland
Local Institution
Barcelona, , Spain
Local Institution
Jaén, , Spain
Local Institution
Madrid, , Spain
Local Institution
Málaga, , Spain
Local Institution
Santiago Compostela, , Spain
Local Institution
Valencia, , Spain
Universitaetsspital Zuerich
Zurich, , Switzerland
Local Institution
London, Greater London, United Kingdom
Local Institution
London, Greater London, United Kingdom
Local Institution
Belfast, , United Kingdom
Local Institution
Cambridge, , United Kingdom
Local Institution
Cottingham, , United Kingdom
Local Institution
Manchester, , United Kingdom
Local Institution
Tauton, , United Kingdom
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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2017-002499-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA017-055
Identifier Type: -
Identifier Source: org_study_id
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