Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03470922




Registration number
NCT03470922
Ethics application status
Date submitted
14/03/2018
Date registered
20/03/2018
Date last updated
21/09/2023

Titles & IDs
Public title
A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma
Scientific title
A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Metastatic or Unresectable Melanoma
Secondary ID [1] 0 0
2017-003583-12
Secondary ID [2] 0 0
CA224-047
Universal Trial Number (UTN)
Trial acronym
RELATIVITY-047
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Relatlimab
Treatment: Other - Nivolumab

Experimental: Arm A: Relatlimab + Nivolumab - Combination

Experimental: Arm B: Nivolumab - Monotherapy


Treatment: Other: Relatlimab
Specified dose on specified day

Treatment: Other: Nivolumab
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
From randomization to date of first documented tumor progression or death (up to approximately 33 months)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From randomization to the date of death (up to approximately 3 years)
Secondary outcome [2] 0 0
Overall Response Rate (ORR)
Timepoint [2] 0 0
From randomization up to approximately 3 years

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



* Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the AJCC staging system
* Participants must not have had prior systemic anticancer therapy for unresectable or metastatic melanoma
* Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants must not have active brain metastases or leptomeningeal metastases
* Participants must not have uveal melanoma
* Participants must not have an active, known, or suspected autoimmune disease

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/12/2025
Actual
Sample size
Target
Accrual to date
Final
714
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Local Institution - 0042 - North Sydney
Recruitment hospital [2] 0 0
Local Institution - 0043 - Waratah
Recruitment hospital [3] 0 0
Local Institution - 0041 - Greenslopes
Recruitment hospital [4] 0 0
Local Institution - 0045 - Southport
Recruitment hospital [5] 0 0
Local Institution - 0133 - Bedford Park
Recruitment hospital [6] 0 0
Local Institution - 0044 - Murdoch
Recruitment postcode(s) [1] 0 0
2060 - North Sydney
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
4120 - Greenslopes
Recruitment postcode(s) [4] 0 0
4215 - Southport
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
Argentina
State/province [15] 0 0
Distrito Federal
Country [16] 0 0
Argentina
State/province [16] 0 0
Buenos Aires
Country [17] 0 0
Argentina
State/province [17] 0 0
Ciudad Autónoma De Buenos Aires
Country [18] 0 0
Austria
State/province [18] 0 0
Graz
Country [19] 0 0
Austria
State/province [19] 0 0
Salzburg
Country [20] 0 0
Austria
State/province [20] 0 0
Wien
Country [21] 0 0
Belgium
State/province [21] 0 0
Brussels
Country [22] 0 0
Belgium
State/province [22] 0 0
Bruxelles
Country [23] 0 0
Belgium
State/province [23] 0 0
Gent
Country [24] 0 0
Brazil
State/province [24] 0 0
Minas Gerais
Country [25] 0 0
Brazil
State/province [25] 0 0
RIO Grande DO SUL
Country [26] 0 0
Brazil
State/province [26] 0 0
SAO Paulo
Country [27] 0 0
Brazil
State/province [27] 0 0
Rio De Janiro
Country [28] 0 0
Brazil
State/province [28] 0 0
Sao Paulo
Country [29] 0 0
Canada
State/province [29] 0 0
Nova Scotia
Country [30] 0 0
Canada
State/province [30] 0 0
Ontario
Country [31] 0 0
Canada
State/province [31] 0 0
Quebec
Country [32] 0 0
Chile
State/province [32] 0 0
Metropolitana
Country [33] 0 0
Colombia
State/province [33] 0 0
Antioquia
Country [34] 0 0
Colombia
State/province [34] 0 0
Bogota
Country [35] 0 0
Denmark
State/province [35] 0 0
Aarhus N
Country [36] 0 0
Denmark
State/province [36] 0 0
Herlev
Country [37] 0 0
Denmark
State/province [37] 0 0
Odense
Country [38] 0 0
Finland
State/province [38] 0 0
Uusimaa
Country [39] 0 0
Finland
State/province [39] 0 0
Oulu
Country [40] 0 0
Finland
State/province [40] 0 0
Tampere
Country [41] 0 0
Finland
State/province [41] 0 0
Turku
Country [42] 0 0
France
State/province [42] 0 0
Ille-et-Vilaine
Country [43] 0 0
France
State/province [43] 0 0
Somme
Country [44] 0 0
France
State/province [44] 0 0
Bordeaux Cedex
Country [45] 0 0
France
State/province [45] 0 0
Lille
Country [46] 0 0
France
State/province [46] 0 0
Marseille
Country [47] 0 0
France
State/province [47] 0 0
Paris
Country [48] 0 0
France
State/province [48] 0 0
Pierre-Benite
Country [49] 0 0
France
State/province [49] 0 0
Poitiers
Country [50] 0 0
Germany
State/province [50] 0 0
Baden-Württemberg
Country [51] 0 0
Germany
State/province [51] 0 0
Sachsen-Anhalt
Country [52] 0 0
Germany
State/province [52] 0 0
Buxtehude
Country [53] 0 0
Germany
State/province [53] 0 0
Erfurt
Country [54] 0 0
Germany
State/province [54] 0 0
Essen
Country [55] 0 0
Germany
State/province [55] 0 0
Hannover
Country [56] 0 0
Germany
State/province [56] 0 0
Heidelberg
Country [57] 0 0
Germany
State/province [57] 0 0
Homburg / Saar
Country [58] 0 0
Germany
State/province [58] 0 0
Köln
Country [59] 0 0
Germany
State/province [59] 0 0
Lubeck
Country [60] 0 0
Germany
State/province [60] 0 0
Mannheim
Country [61] 0 0
Germany
State/province [61] 0 0
Muenchen
Country [62] 0 0
Germany
State/province [62] 0 0
Wuerzburg
Country [63] 0 0
Greece
State/province [63] 0 0
Athens
Country [64] 0 0
Greece
State/province [64] 0 0
Thessaloniki
Country [65] 0 0
Israel
State/province [65] 0 0
Haifa
Country [66] 0 0
Israel
State/province [66] 0 0
Jerusalem
Country [67] 0 0
Israel
State/province [67] 0 0
Ramat-gan
Country [68] 0 0
Italy
State/province [68] 0 0
Piemonte
Country [69] 0 0
Italy
State/province [69] 0 0
Bergamo
Country [70] 0 0
Italy
State/province [70] 0 0
Milano
Country [71] 0 0
Italy
State/province [71] 0 0
Napoli
Country [72] 0 0
Italy
State/province [72] 0 0
Padova
Country [73] 0 0
Italy
State/province [73] 0 0
Siena
Country [74] 0 0
Mexico
State/province [74] 0 0
Jalisco
Country [75] 0 0
Mexico
State/province [75] 0 0
Nuevo LEON
Country [76] 0 0
Mexico
State/province [76] 0 0
Quintana Roo
Country [77] 0 0
Mexico
State/province [77] 0 0
Yucatan
Country [78] 0 0
Mexico
State/province [78] 0 0
Veracruz
Country [79] 0 0
New Zealand
State/province [79] 0 0
Dunedin
Country [80] 0 0
New Zealand
State/province [80] 0 0
Hamilton
Country [81] 0 0
New Zealand
State/province [81] 0 0
Tauranga
Country [82] 0 0
Norway
State/province [82] 0 0
Oslo
Country [83] 0 0
Poland
State/province [83] 0 0
Wielkopolskie
Country [84] 0 0
Poland
State/province [84] 0 0
Warszawa
Country [85] 0 0
Romania
State/province [85] 0 0
Cluj
Country [86] 0 0
Romania
State/province [86] 0 0
Bucharest
Country [87] 0 0
Romania
State/province [87] 0 0
Craiova
Country [88] 0 0
Romania
State/province [88] 0 0
Iasi
Country [89] 0 0
Russian Federation
State/province [89] 0 0
Krasnodar
Country [90] 0 0
Russian Federation
State/province [90] 0 0
Krasnoyarsk
Country [91] 0 0
Russian Federation
State/province [91] 0 0
Moscow
Country [92] 0 0
Spain
State/province [92] 0 0
A Coruña
Country [93] 0 0
Spain
State/province [93] 0 0
Barcelona
Country [94] 0 0
Spain
State/province [94] 0 0
Madrid
Country [95] 0 0
Spain
State/province [95] 0 0
San Sabastian Gipuzkoa
Country [96] 0 0
Spain
State/province [96] 0 0
Sevilla
Country [97] 0 0
Sweden
State/province [97] 0 0
Goteborg
Country [98] 0 0
Sweden
State/province [98] 0 0
Lund
Country [99] 0 0
Sweden
State/province [99] 0 0
Solna
Country [100] 0 0
Sweden
State/province [100] 0 0
Uppsala
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Avon
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Dumfries & Galloway
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Glamorgan
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Greater London
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Inverness-shire

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/NCT03470922