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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/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
Other interventions - Nivolumab
Other interventions - Nivolumab + Relatlimab Fixed Dose Combination

Experimental: Arm A: Nivolumab Plus Relatlimab - Combination

Experimental: Arm B: Nivolumab - Monotherapy


Other interventions: Nivolumab
Specified dose on specified days

Other interventions: Nivolumab + Relatlimab Fixed Dose Combination
Specified dose on specified days
Intervention code [1] 0 0
Other interventions
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
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Alabama
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Arkansas
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State/province [3] 0 0
California
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Colorado
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District of Columbia
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Florida
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Georgia
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Illinois
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Indiana
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Iowa
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Kansas
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Michigan
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Minnesota
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New Jersey
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New York
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Virginia
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Argentina
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Distrito Federal
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Austria
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Steiermark
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Austria
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Salzburg
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Austria
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Vienna
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Belgium
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Brussels
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Belgium
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Bruxelles
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Belgium
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Liège
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Belgium
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Wilrijk
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Brazil
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Bahia
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Ceara
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Espirito Santo
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Brazil
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Minas Gerais
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Brazil
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Rio Grande Do Sul
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Brazil
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RIO Grande DO SUL
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SAO Paulo
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Brazil
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Rio de Janeiro
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Alberta
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British Columbia
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Nova Scotia
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Quebec
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Chile
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Metropolitana
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Beijing
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China
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Chongqing
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Fujian
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Guangdong
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China
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Henan
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Hubei
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Hunan
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Jiangsu
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Jiangxi
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Jilin
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Liaoning
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Sichuan
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China
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Tianjin
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China
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Xinjiang
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China
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Yunnan
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China
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Zhejiang
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China
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Taiyuan
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Ostrava
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Czechia
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Prague
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Denmark
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Aalborg
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Denmark
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Copenhagen
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Denmark
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Odense
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Finland
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Helsinki
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Finland
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Tampere
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Finland
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Turku
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France
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Val-de-Marne
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France
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Dijon
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France
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Marseille
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Nantes
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Paris
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France
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Pierre-Bénite
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France
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Toulouse
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Germany
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Baden-Württemberg
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Germany
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Lower Saxony
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Germany
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Buxtehude
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Germany
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Dresden
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Germany
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Erlangen
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Germany
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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
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Germany
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Munich
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Germany
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Wuerzburg
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Greece
State/province [92] 0 0
Athens
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Greece
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Neo Faliro
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Greece
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Thessaloniki
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Israel
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Yerushalayim
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Israel
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Afula
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Israel
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Ramag Gan
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Israel
State/province [98] 0 0
Ramat Gan
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Italy
State/province [99] 0 0
Milano
Country [100] 0 0
Italy
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Milan
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Italy
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Napoli
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Italy
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Padova
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Italy
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Perugia
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Italy
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Siena
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Mexico
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Distrito Federal
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Mexico
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Jalisco
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Mexico
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Nuevo LEON
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Mexico
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Oaxaca
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Norway
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Akershus
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Norway
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Oslo
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Norway
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Stavanger
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Romania
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Brasov
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Romania
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Cluj
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Romania
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Craiova
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Romania
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Floresti/ Cluj
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Spain
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Badajoz
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Spain
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Barcelona
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Spain
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Granada
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Spain
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Madrid
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Spain
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San Sebastian
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Spain
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València
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Sweden
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Gothenburg
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Sweden
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Lund
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Sweden
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Solna
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Switzerland
State/province [125] 0 0
Basel
Country [126] 0 0
Switzerland
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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
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Nottinghamshire
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Bristol
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United Kingdom
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Newcastle upon Tyne
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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
The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC)
versus nivolumab alone in participants with completely resected stage III-IV melanoma.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05002569
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05002569