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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03329846




Registration number
NCT03329846
Ethics application status
Date submitted
31/10/2017
Date registered
6/11/2017
Date last updated
9/07/2021

Titles & IDs
Public title
An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma
Scientific 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
Secondary ID [1] 0 0
2017-002499-14
Secondary ID [2] 0 0
CA017-055
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Skin Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986205
Treatment: Other - Nivolumab
Treatment: Drugs - Placebo

Active comparator: Nivolumab + Placebo - Specified dose on specified day

Participants will no longer receive BMS-986205 Placebo

Experimental: Nivolumab + BMS-986205 - Specified dose on specified day.

Participants have the option to discontinue BMS-986205, and continue nivolumab monotherapy, at investigator discretion


Treatment: Drugs: BMS-986205
specified dose on specified day

Treatment: Other: Nivolumab
Specified dose on specified day

Treatment: Drugs: Placebo
Specified dose on specified day
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Experiencing Adverse Events
Timepoint [1] 0 0
From first dose to 30 days following last dose (up to approximately 25 months)

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



* 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
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/07/2020
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Local Institution - Blacktown
Recruitment hospital [2] 0 0
Melanoma Institute Australia - North Sydney
Recruitment hospital [3] 0 0
Local Institution - Greenslopes
Recruitment hospital [4] 0 0
Local Institution - Woolloongabba
Recruitment hospital [5] 0 0
Local Institution - Box Hill
Recruitment hospital [6] 0 0
Local Institution - Melbourne
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2146 - North Sydney
Recruitment postcode(s) [3] 0 0
4120 - Greenslopes
Recruitment postcode(s) [4] 0 0
4120 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3000 - Melbourne
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Oregon
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington
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Canada
State/province [7] 0 0
Quebec
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Czechia
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Hradec Kralove
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Czechia
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Praha 10
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Czechia
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Praha 2
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France
State/province [11] 0 0
Boulogne-billancourt
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France
State/province [12] 0 0
Saint Etienne Cedex 2
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France
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Villejuif Cedex
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Germany
State/province [14] 0 0
Buxtehude
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Germany
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Dresden
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Germany
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Essen
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Germany
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Gera
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Germany
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Goettingen
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Germany
State/province [19] 0 0
Hannover
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Germany
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Heidelberg
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Germany
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Muenchen
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Germany
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Tuebingen
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Greece
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Thessaloniki
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Ireland
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Limerick
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Ireland
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Dublin
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Italy
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Milano
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Italy
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Napoli
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Italy
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Siena
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Japan
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Miyagi
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Japan
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Niigata
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Japan
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Okayama
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Japan
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Osaka
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Japan
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Tokyo
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Netherlands
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Amsterdam
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Netherlands
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Groningen
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Netherlands
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Nijmegen
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Netherlands
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Rotterdam
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New Zealand
State/province [38] 0 0
Christchurch
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New Zealand
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Wellington
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Poland
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Warszawa
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Spain
State/province [41] 0 0
Barcelona
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Spain
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Jaen
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Santiago Compostela
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Spain
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Valencia
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Switzerland
State/province [47] 0 0
Zürich
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United Kingdom
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Greater London
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United Kingdom
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Belfast
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United Kingdom
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Cambridge
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United Kingdom
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Cottingham
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United Kingdom
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Manchester
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United Kingdom
State/province [53] 0 0
Tauton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03329846