Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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/NCT05002569




Registration number
NCT05002569
Ethics application status
Date submitted
4/08/2021
Date registered
12/08/2021
Date last updated
18/09/2023

Titles & IDs
Public title
A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma
Scientific title
A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab + Relatlimab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV Melanoma
Secondary ID [1] 0 0
2021-001641-13
Secondary ID [2] 0 0
CA224-098
Universal Trial Number (UTN)
Trial acronym
RELATIVITY-098
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(has expanded access)
Description of intervention(s) / exposure
Treatment: Other - Nivolumab
Treatment: Other - Nivolumab + Relatlimab Fixed Dose Combination

Experimental: Arm A: Nivolumab Plus Relatlimab - Combination

Experimental: Arm B: Nivolumab - Monotherapy


Treatment: Other: Nivolumab
Specified dose on specified days

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

Outcomes
Primary outcome [1] 0 0
Recurrence-Free Survival (RFS) time per Investigator assessment
Timepoint [1] 0 0
Approximately 52 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Approximately 90 months
Secondary outcome [2] 0 0
Distant Metastasis-Free Survival (DMFS) time per Investigator assessment
Timepoint [2] 0 0
Approximately 90 months
Secondary outcome [3] 0 0
Incidence of Adverse Events (AEs)
Timepoint [3] 0 0
30 days from participant's last dose
Secondary outcome [4] 0 0
Severity of AEs
Timepoint [4] 0 0
30 days from participant's last dose
Secondary outcome [5] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [5] 0 0
30 days from participant's last dose
Secondary outcome [6] 0 0
Severity of SAEs
Timepoint [6] 0 0
30 days from participant's last dose
Secondary outcome [7] 0 0
Incidence of AEs leading to discontinuation (DC)
Timepoint [7] 0 0
30 days from participant's last dose
Secondary outcome [8] 0 0
Severity of AEs leading to DC
Timepoint [8] 0 0
30 days from participant's last dose
Secondary outcome [9] 0 0
Incidence of immune-mediated AEs (IMAEs)
Timepoint [9] 0 0
135 days from participant's last dose
Secondary outcome [10] 0 0
Severity of IMAEs
Timepoint [10] 0 0
135 days from participant's last dose
Secondary outcome [11] 0 0
Incidence of drug related AEs
Timepoint [11] 0 0
30 days from participant's last dose
Secondary outcome [12] 0 0
Severity of drug related AEs
Timepoint [12] 0 0
30 days from participant's last dose
Secondary outcome [13] 0 0
Incidence of deaths
Timepoint [13] 0 0
30 days from participant's last dose
Secondary outcome [14] 0 0
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Timepoint [14] 0 0
30 days from participant's last dose
Secondary outcome [15] 0 0
Incidence of clinically significant changes in clinical laboratory values: Chemistry tests
Timepoint [15] 0 0
30 days from participant's last dose
Secondary outcome [16] 0 0
Progression-Free Survival 2 (PFS2)
Timepoint [16] 0 0
Approximately 52 months

Eligibility
Key inclusion criteria
* Must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by American Joint Committee on Cancer (AJCC) v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible
* Participants = 18 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status of = 1. Adolescent participants between 12 and < 18 years of age must have a Lansky/Karnofsky performance score = 80%
* Complete resection must be performed within 90 days prior to randomization
* All participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization
* Tumor tissue 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
* History of ocular melanoma
* Untreated/unresected CNS metastases or leptomeningeal metastases
* Active, known, or suspected autoimmune disease
* Participants with serious or uncontrolled medical disorder
* Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted
* Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks prior to screening
* History of myocarditis, regardless of etiology.

Other protocol-defined inclusion/exclusion criteria 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 3
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
19/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2029
Actual
Sample size
Target
1050
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0030 - Waratah
Recruitment hospital [2] 0 0
Local Institution - 0252 - Westmead
Recruitment hospital [3] 0 0
Local Institution - 0032 - Wollstonecraft
Recruitment hospital [4] 0 0
Local Institution - 0028 - Brisbane
Recruitment hospital [5] 0 0
Local Institution - 0027 - Southport
Recruitment hospital [6] 0 0
Local Institution - 0250 - Woodville
Recruitment hospital [7] 0 0
Local Institution - Ballarat Central
Recruitment hospital [8] 0 0
Local Institution - 0035 - Ballarat
Recruitment hospital [9] 0 0
Local Institution - 0253 - Heidelberg
Recruitment hospital [10] 0 0
Local Institution - 0031 - Melbourne
Recruitment hospital [11] 0 0
Local Institution - 0251 - Murdoch
Recruitment hospital [12] 0 0
Local Institution - 0029 - Perth
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
2065 - Wollstonecraft
Recruitment postcode(s) [4] 0 0
4102 - Brisbane
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
5011 - Woodville
Recruitment postcode(s) [7] 0 0
3350 - Ballarat Central
Recruitment postcode(s) [8] 0 0
3350 - Ballarat
Recruitment postcode(s) [9] 0 0
3084 - Heidelberg
Recruitment postcode(s) [10] 0 0
3000 - Melbourne
Recruitment postcode(s) [11] 0 0
6150 - Murdoch
Recruitment postcode(s) [12] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
Argentina
State/province [23] 0 0
Distrito Federal
Country [24] 0 0
Argentina
State/province [24] 0 0
Buenos Aires
Country [25] 0 0
Argentina
State/province [25] 0 0
Cordoba
Country [26] 0 0
Austria
State/province [26] 0 0
Steiermark
Country [27] 0 0
Austria
State/province [27] 0 0
Salzburg
Country [28] 0 0
Austria
State/province [28] 0 0
Vienna
Country [29] 0 0
Belgium
State/province [29] 0 0
Brussels
Country [30] 0 0
Belgium
State/province [30] 0 0
Bruxelles
Country [31] 0 0
Belgium
State/province [31] 0 0
Liège
Country [32] 0 0
Belgium
State/province [32] 0 0
Wilrijk
Country [33] 0 0
Brazil
State/province [33] 0 0
Bahia
Country [34] 0 0
Brazil
State/province [34] 0 0
Ceara
Country [35] 0 0
Brazil
State/province [35] 0 0
Espirito Santo
Country [36] 0 0
Brazil
State/province [36] 0 0
Minas Gerais
Country [37] 0 0
Brazil
State/province [37] 0 0
Rio Grande Do Sul
Country [38] 0 0
Brazil
State/province [38] 0 0
RIO Grande DO SUL
Country [39] 0 0
Brazil
State/province [39] 0 0
SAO Paulo
Country [40] 0 0
Brazil
State/province [40] 0 0
Rio de Janeiro
Country [41] 0 0
Canada
State/province [41] 0 0
Alberta
Country [42] 0 0
Canada
State/province [42] 0 0
British Columbia
Country [43] 0 0
Canada
State/province [43] 0 0
Nova Scotia
Country [44] 0 0
Canada
State/province [44] 0 0
Quebec
Country [45] 0 0
Chile
State/province [45] 0 0
Metropolitana
Country [46] 0 0
China
State/province [46] 0 0
Beijing
Country [47] 0 0
China
State/province [47] 0 0
Chongqing
Country [48] 0 0
China
State/province [48] 0 0
Fujian
Country [49] 0 0
China
State/province [49] 0 0
Guangdong
Country [50] 0 0
China
State/province [50] 0 0
Henan
Country [51] 0 0
China
State/province [51] 0 0
Hubei
Country [52] 0 0
China
State/province [52] 0 0
Hunan
Country [53] 0 0
China
State/province [53] 0 0
Jiangsu
Country [54] 0 0
China
State/province [54] 0 0
Jiangxi
Country [55] 0 0
China
State/province [55] 0 0
Jilin
Country [56] 0 0
China
State/province [56] 0 0
Liaoning
Country [57] 0 0
China
State/province [57] 0 0
Sichuan
Country [58] 0 0
China
State/province [58] 0 0
Tianjin
Country [59] 0 0
China
State/province [59] 0 0
Xinjiang
Country [60] 0 0
China
State/province [60] 0 0
Yunnan
Country [61] 0 0
China
State/province [61] 0 0
Zhejiang
Country [62] 0 0
China
State/province [62] 0 0
Taiyuan
Country [63] 0 0
Czechia
State/province [63] 0 0
Brno
Country [64] 0 0
Czechia
State/province [64] 0 0
Hradec Kralove
Country [65] 0 0
Czechia
State/province [65] 0 0
Ostrava
Country [66] 0 0
Czechia
State/province [66] 0 0
Prague
Country [67] 0 0
Denmark
State/province [67] 0 0
Aalborg
Country [68] 0 0
Denmark
State/province [68] 0 0
Copenhagen
Country [69] 0 0
Denmark
State/province [69] 0 0
Odense
Country [70] 0 0
Finland
State/province [70] 0 0
Helsinki
Country [71] 0 0
Finland
State/province [71] 0 0
Tampere
Country [72] 0 0
Finland
State/province [72] 0 0
Turku
Country [73] 0 0
France
State/province [73] 0 0
Val-de-Marne
Country [74] 0 0
France
State/province [74] 0 0
Dijon
Country [75] 0 0
France
State/province [75] 0 0
Marseille
Country [76] 0 0
France
State/province [76] 0 0
Nantes
Country [77] 0 0
France
State/province [77] 0 0
Paris
Country [78] 0 0
France
State/province [78] 0 0
Pierre-Bénite
Country [79] 0 0
France
State/province [79] 0 0
Toulouse
Country [80] 0 0
Germany
State/province [80] 0 0
Baden-Württemberg
Country [81] 0 0
Germany
State/province [81] 0 0
Lower Saxony
Country [82] 0 0
Germany
State/province [82] 0 0
Buxtehude
Country [83] 0 0
Germany
State/province [83] 0 0
Dresden
Country [84] 0 0
Germany
State/province [84] 0 0
Erlangen
Country [85] 0 0
Germany
State/province [85] 0 0
Essen
Country [86] 0 0
Germany
State/province [86] 0 0
Gera
Country [87] 0 0
Germany
State/province [87] 0 0
Heidelberg
Country [88] 0 0
Germany
State/province [88] 0 0
Lübeck
Country [89] 0 0
Germany
State/province [89] 0 0
Minden
Country [90] 0 0
Germany
State/province [90] 0 0
Munich
Country [91] 0 0
Germany
State/province [91] 0 0
Wuerzburg
Country [92] 0 0
Greece
State/province [92] 0 0
Athens
Country [93] 0 0
Greece
State/province [93] 0 0
Neo Faliro
Country [94] 0 0
Greece
State/province [94] 0 0
Thessaloniki
Country [95] 0 0
Israel
State/province [95] 0 0
Yerushalayim
Country [96] 0 0
Israel
State/province [96] 0 0
Afula
Country [97] 0 0
Israel
State/province [97] 0 0
Ramag Gan
Country [98] 0 0
Israel
State/province [98] 0 0
Ramat Gan
Country [99] 0 0
Italy
State/province [99] 0 0
Milano
Country [100] 0 0
Italy
State/province [100] 0 0
Milan
Country [101] 0 0
Italy
State/province [101] 0 0
Napoli
Country [102] 0 0
Italy
State/province [102] 0 0
Padova
Country [103] 0 0
Italy
State/province [103] 0 0
Perugia
Country [104] 0 0
Italy
State/province [104] 0 0
Siena
Country [105] 0 0
Mexico
State/province [105] 0 0
Distrito Federal
Country [106] 0 0
Mexico
State/province [106] 0 0
Jalisco
Country [107] 0 0
Mexico
State/province [107] 0 0
Nuevo LEON
Country [108] 0 0
Mexico
State/province [108] 0 0
Oaxaca
Country [109] 0 0
Norway
State/province [109] 0 0
Akershus
Country [110] 0 0
Norway
State/province [110] 0 0
Oslo
Country [111] 0 0
Norway
State/province [111] 0 0
Stavanger
Country [112] 0 0
Romania
State/province [112] 0 0
Brasov
Country [113] 0 0
Romania
State/province [113] 0 0
Cluj
Country [114] 0 0
Romania
State/province [114] 0 0
Craiova
Country [115] 0 0
Romania
State/province [115] 0 0
Floresti/ Cluj
Country [116] 0 0
Spain
State/province [116] 0 0
Badajoz
Country [117] 0 0
Spain
State/province [117] 0 0
Barcelona
Country [118] 0 0
Spain
State/province [118] 0 0
Granada
Country [119] 0 0
Spain
State/province [119] 0 0
Madrid
Country [120] 0 0
Spain
State/province [120] 0 0
San Sebastian
Country [121] 0 0
Spain
State/province [121] 0 0
València
Country [122] 0 0
Sweden
State/province [122] 0 0
Gothenburg
Country [123] 0 0
Sweden
State/province [123] 0 0
Lund
Country [124] 0 0
Sweden
State/province [124] 0 0
Solna
Country [125] 0 0
Switzerland
State/province [125] 0 0
Basel
Country [126] 0 0
Switzerland
State/province [126] 0 0
Chur
Country [127] 0 0
Switzerland
State/province [127] 0 0
Zürich
Country [128] 0 0
United Kingdom
State/province [128] 0 0
Lanarkshire
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Nottinghamshire
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Bristol
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Newcastle upon Tyne
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Oxford
Country [133] 0 0
United Kingdom
State/province [133] 0 0
Southampton

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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05002569