Clinical trial NCT03329846: An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma
Official title: A Phase 3, Randomized, Double-blind Study of BMS-986205 Combined With Nivolumab Versus Nivolumab in Participants With Metastatic or Unresectable Melanoma That is Previously Untreated
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Melanoma
Skin Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if BMS-986205 combined with nivolumab, compared to nivolumab by itself, is more effective in treating Melanoma that has spread or is unable to be removed by surgery, and has not previously been treated


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* 12 years and older unless not permitted by local regulations; in that case 18 years old and older
* 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:

* Active brain metastases or leptomeningeal metastases
* 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

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Number of Participants Experiencing Adverse Events
timeFrame: From first dose to 30 days following last dose (up to approximately 25 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Angeles Clinic and Research Institute
state: California
city: Aurora
country: United States
facility: University Of Colorado
state: Colorado
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Chicago
country: United States
facility: University Of Chicago
state: Illinois
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Seattle
country: United States
facility: Local Institution
state: Washington
city: Blacktown
country: Australia
facility: Local Institution
state: New South Wales
city: North Sydney
country: Australia
facility: Melanoma Institute Australia
state: New South Wales
city: Greenslopes
country: Australia
facility: Local Institution
state: Queensland
city: Woolloongabba
country: Australia
facility: Local Institution
state: Queensland
city: Box Hill
country: Australia
facility: Local Institution
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Quebec
country: Canada
facility: Local Institution
city: Hradec Kralove
country: Czechia
facility: Klinika onkologie a radioterapie
city: Praha 10
country: Czechia
facility: Dermatovenerologicka klinika 3. LF UK a FNKV
city: Praha 2
country: Czechia
facility: Dermatovenerologicka klinika VFN a 1. LF UK
city: Boulogne-billancourt
country: France
facility: Local Institution
city: Saint Etienne Cedex 2
country: France
facility: Local Institution
city: Villejuif Cedex
country: France
facility: Local Institution
city: Buxtehude
country: Germany
facility: Elbe Klinikum Buxtehude
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus
city: Essen
country: Germany
facility: Local Institution
city: Gera
country: Germany
facility: SRH Wald-Kliniken Gera GmbH
city: Goettingen
country: Germany
facility: Georg August Universitaet Goettingen
city: Hannover
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Muenchen
country: Germany
facility: Local Institution
city: Tuebingen
country: Germany
facility: Local Institution
city: Thessaloniki
country: Greece
facility: Interbalkan European Medical Center
city: Dooradoyle
country: Ireland
facility: Local Institution
state: Limerick
city: Dublin
country: Ireland
facility: Local Institution
city: Dublin
country: Ireland
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione Pascale
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
city: Sendai-shi
country: Japan
facility: Local Institution
state: Miyagi
city: Niigata-shi
country: Japan
facility: Local Institution
state: Niigata
city: Okayama-shi
country: Japan
facility: Local Institution
state: Okayama
city: Osaka-shi
country: Japan
facility: Local Institution
state: Osaka
city: Chuo-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Groningen
country: Netherlands
facility: Local Institution
city: Nijmegen
country: Netherlands
facility: Local Institution
city: Rotterdam
country: Netherlands
facility: Local Institution
city: Christchurch
country: New Zealand
facility: Local Institution
city: Wellington
country: New Zealand
facility: Local Institution
city: Warszawa
country: Poland
facility: Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
city: Barcelona
country: Spain
facility: Local Institution
city: Jaen
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Malaga
country: Spain
facility: Local Institution
city: Santiago Compostela
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Zürich
country: Switzerland
facility: Universitaetsspital Zuerich
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Belfast
country: United Kingdom
facility: Local Institution
city: Cambridge
country: United Kingdom
facility: Local Institution
city: Cottingham
country: United Kingdom
facility: Local Institution
city: Manchester
country: United Kingdom
facility: Local Institution
city: Tauton
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: