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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Other interventions - 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

Other interventions: 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
Other interventions
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
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
Czechia
State/province [8] 0 0
Hradec Kralove
Country [9] 0 0
Czechia
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Praha 10
Country [10] 0 0
Czechia
State/province [10] 0 0
Praha 2
Country [11] 0 0
France
State/province [11] 0 0
Boulogne-billancourt
Country [12] 0 0
France
State/province [12] 0 0
Saint Etienne Cedex 2
Country [13] 0 0
France
State/province [13] 0 0
Villejuif Cedex
Country [14] 0 0
Germany
State/province [14] 0 0
Buxtehude
Country [15] 0 0
Germany
State/province [15] 0 0
Dresden
Country [16] 0 0
Germany
State/province [16] 0 0
Essen
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Germany
State/province [17] 0 0
Gera
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Germany
State/province [18] 0 0
Goettingen
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Germany
State/province [19] 0 0
Hannover
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Germany
State/province [20] 0 0
Heidelberg
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Germany
State/province [21] 0 0
Muenchen
Country [22] 0 0
Germany
State/province [22] 0 0
Tuebingen
Country [23] 0 0
Greece
State/province [23] 0 0
Thessaloniki
Country [24] 0 0
Ireland
State/province [24] 0 0
Limerick
Country [25] 0 0
Ireland
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Dublin
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Italy
State/province [26] 0 0
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
State/province [29] 0 0
Miyagi
Country [30] 0 0
Japan
State/province [30] 0 0
Niigata
Country [31] 0 0
Japan
State/province [31] 0 0
Okayama
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Japan
State/province [32] 0 0
Osaka
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Japan
State/province [33] 0 0
Tokyo
Country [34] 0 0
Netherlands
State/province [34] 0 0
Amsterdam
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Netherlands
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Groningen
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Netherlands
State/province [36] 0 0
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
State/province [48] 0 0
Greater London
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United Kingdom
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Belfast
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United Kingdom
State/province [50] 0 0
Cambridge
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United Kingdom
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Cottingham
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United Kingdom
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Manchester
Country [53] 0 0
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
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT03329846
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