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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06561386




Registration number
NCT06561386
Ethics application status
Date submitted
16/08/2024
Date registered
20/08/2024

Titles & IDs
Public title
A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 1-49%
Scientific title
A Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy as First-line Treatment for Participants With Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and With Tumor Cell PD-L1 Expression of 1% to 49%
Secondary ID [1] 0 0
CA224-1093
Universal Trial Number (UTN)
Trial acronym
RELATIVITY1093
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nivolumab
Treatment: Drugs - Relatlimab
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Cisplatin

Experimental: Arm A -

Active comparator: Arm B -


Treatment: Drugs: Nivolumab
Specified dose on specified days

Treatment: Drugs: Relatlimab
Specified dose on specified days

Treatment: Drugs: Pembrolizumab
Specified dose on specified days

Treatment: Drugs: Carboplatin
Specified dose on specified days

Treatment: Drugs: Pemetrexed
Specified dose on specified days

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

Outcomes
Primary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [1] 0 0
Progression-free survival (PFS)
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [2] 0 0
Overall response rate (ORR)
Timepoint [2] 0 0
Up to 5 years
Secondary outcome [3] 0 0
Duration of response (DoR)
Timepoint [3] 0 0
Up to 5 years
Secondary outcome [4] 0 0
Number of participants with adverse events (AEs)
Timepoint [4] 0 0
Up to 2.5 years
Secondary outcome [5] 0 0
Number of participants with serious adverse events (SAEs)
Timepoint [5] 0 0
Up to 2.5 years
Secondary outcome [6] 0 0
Number of participants with immune-mediated adverse events (IMAEs)
Timepoint [6] 0 0
Up to 2.5 years
Secondary outcome [7] 0 0
The time until definitive deterioration based on non-small cell lung cancer - symptom assessment questionnaire (NSCLC-SAQ) total score
Timepoint [7] 0 0
Up to 2 years

Eligibility
Key inclusion criteria
Inclusion Criteria

* Participants must have histologically confirmed Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with tumor cell PD-L1 expression 1% to 49% as determined by a central laboratory
* Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria.
* Participants must have an Easter Cooperative Oncology Group (ECOG) performance status of = 1 at screening.
* Participants must have no prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic disease.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Participants must not have epidermal growth factor receptor (EGFR) mutations, anaplastic lymphoma kinase (ALK) translocations, ROS-1 translocations and known BRAFV600E, that are sensitive to available targeted inhibitor therapy; participants with known activating rearranged during transfection (RET) mutations and neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations.
* Participants must not have untreated central nervous system (CNS) metastases.
* Participants must not have concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to randomization.
* Participants must not have an active autoimmune disease.
* Participants must not have history of interstitial lung disease or pneumonitis that required oral or intravenous (IV) glucocorticoids.
* Participants must not have a history of myocarditis, regardless of etiology.
* Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or other antibody or drug targeting T-cell co-stimulation or checkpoint pathways.
* 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
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
11/11/2033
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Gosford Hospital - Gosford
Recruitment hospital [2] 0 0
Local Institution - 0061 - St Leonards
Recruitment hospital [3] 0 0
Local Institution - 0243 - Brisbane
Recruitment hospital [4] 0 0
Gallipoli Medical Research Ltd - Brisbane
Recruitment hospital [5] 0 0
Local Institution - 0057 - Elizabeth Vale
Recruitment hospital [6] 0 0
Local Institution - 0054 - Box Hill
Recruitment hospital [7] 0 0
Local Institution - 0053 - Murdoch
Recruitment hospital [8] 0 0
St. John of God Murdoch Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4032 - Brisbane
Recruitment postcode(s) [4] 0 0
4120 - Brisbane
Recruitment postcode(s) [5] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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United States of America
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Florida
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United States of America
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Kentucky
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United States of America
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Mississippi
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United States of America
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Montana
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Nevada
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New Jersey
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New Mexico
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New York
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Ohio
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Pennsylvania
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Texas
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United States of America
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Utah
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Argentina
State/province [15] 0 0
Buenos Aires
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Argentina
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Ciudad Autónoma De Buenos Aires
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Argentina
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Córdoba
Country [18] 0 0
Argentina
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Santa Fe
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Austria
State/province [19] 0 0
Niederösterreich
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Austria
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Oberösterreich
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Austria
State/province [21] 0 0
Feldkirch
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Austria
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Wien
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Belgium
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Bruxelles-Capitale, Région De
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Belgium
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Limburg
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Belgium
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Namur
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Belgium
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West-Vlaanderen
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Brazil
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Ceará
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Brazil
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Minas Gerais
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Brazil
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Pará
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Brazil
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Rio Grande Do Norte
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Brazil
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Rio Grande Do Sul
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Brazil
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Santa Catarina
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Brazil
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São Paulo
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Brazil
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Rio de Janeiro
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Chile
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Región Metropolitana De Santiago
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China
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Anhui
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China
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Beijing
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China
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Chongqing
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China
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Fujian
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China
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Guangdong
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China
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Guangxi
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China
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Heilongjiang
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China
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Henan
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China
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Hubei
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China
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Hunan
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China
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Jiangsu
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China
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Liaoning
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China
State/province [48] 0 0
Shandong
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China
State/province [49] 0 0
Shanghai
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China
State/province [50] 0 0
Sichuan
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China
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Tianjin
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China
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Zhejiang
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Denmark
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Midtjylland
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Denmark
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Syddanmark
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Denmark
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Copenhagen
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France
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Hérault
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France
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Ille-et-Vilaine
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France
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Nord-Pas-de-Calais
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France
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Provence-Alpes-Côte-d'Azur
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France
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Rhône
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France
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Marseille
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France
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Paris
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Germany
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Baden-Württemberg
Country [64] 0 0
Germany
State/province [64] 0 0
Bayern
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Germany
State/province [65] 0 0
Hessen
Country [66] 0 0
Germany
State/province [66] 0 0
Nordrhein-Westfalen
Country [67] 0 0
Germany
State/province [67] 0 0
Schleswig-Holstein
Country [68] 0 0
Germany
State/province [68] 0 0
Thüringen
Country [69] 0 0
Germany
State/province [69] 0 0
Berlin
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Germany
State/province [70] 0 0
Bonn
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Germany
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Essen
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Germany
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Gauting
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Germany
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Heidelberg
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India
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Delhi
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India
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Karnataka
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India
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Kerala
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India
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Maharashtra
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India
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West Bengal
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Ireland
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Dublin
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Italy
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Lombardia
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Italy
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Napoli
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Italy
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Puglia
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Italy
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Roma
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Italy
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Verona
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Hiroshima
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Japan
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Hokkaido
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Japan
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Kanagawa
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Japan
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Miyagi
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Japan
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Nara
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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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Saitama
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Japan
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Shizuoka
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Japan
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Tokyo
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Japan
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Akashi
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Japan
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Fukushima
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Korea, Republic of
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Chungcheongbuk-do [Chungbuk]
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Korea, Republic of
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Incheon-gwangyeoksi [Incheon]
Country [102] 0 0
Korea, Republic of
State/province [102] 0 0
Kyonggi-do
Country [103] 0 0
Korea, Republic of
State/province [103] 0 0
Seoul-teukbyeolsi [Seoul]
Country [104] 0 0
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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Querétaro
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Mexico
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San Luis Potosí
Country [108] 0 0
Netherlands
State/province [108] 0 0
Gelderland
Country [109] 0 0
Netherlands
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Limburg
Country [110] 0 0
Netherlands
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Noord-Brabant
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Netherlands
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Overijssel
Country [112] 0 0
Netherlands
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Zuid-Holland
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Netherlands
State/province [113] 0 0
Arnhem
Country [114] 0 0
Netherlands
State/province [114] 0 0
Groningen
Country [115] 0 0
Poland
State/province [115] 0 0
Mazowieckie
Country [116] 0 0
Poland
State/province [116] 0 0
Pomorskie
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Poland
State/province [117] 0 0
Wielkopolskie
Country [118] 0 0
Poland
State/province [118] 0 0
Zachodniopomorskie
Country [119] 0 0
Poland
State/province [119] 0 0
Bydgoszcz
Country [120] 0 0
Poland
State/province [120] 0 0
Lódzkie
Country [121] 0 0
Portugal
State/province [121] 0 0
Lisboa
Country [122] 0 0
Portugal
State/province [122] 0 0
Coimbra
Country [123] 0 0
Portugal
State/province [123] 0 0
Porto
Country [124] 0 0
Romania
State/province [124] 0 0
Bucure?ti
Country [125] 0 0
Romania
State/province [125] 0 0
Cluj
Country [126] 0 0
Romania
State/province [126] 0 0
Dolj
Country [127] 0 0
Romania
State/province [127] 0 0
Prahova
Country [128] 0 0
Romania
State/province [128] 0 0
Ia?i
Country [129] 0 0
Saudi Arabia
State/province [129] 0 0
Ar Riya?
Country [130] 0 0
Saudi Arabia
State/province [130] 0 0
Makkah Al Mukarramah
Country [131] 0 0
Spain
State/province [131] 0 0
A Coruña [La Coruña]
Country [132] 0 0
Spain
State/province [132] 0 0
Barcelona [Barcelona]
Country [133] 0 0
Spain
State/province [133] 0 0
Catalunya [Cataluña]
Country [134] 0 0
Spain
State/province [134] 0 0
Madrid, Comunidad De
Country [135] 0 0
Spain
State/province [135] 0 0
Málaga
Country [136] 0 0
Spain
State/province [136] 0 0
Sevilla
Country [137] 0 0
Spain
State/province [137] 0 0
València
Country [138] 0 0
Switzerland
State/province [138] 0 0
Sankt Gallen
Country [139] 0 0
Switzerland
State/province [139] 0 0
Ticino
Country [140] 0 0
Switzerland
State/province [140] 0 0
Vaud
Country [141] 0 0
Switzerland
State/province [141] 0 0
Basel
Country [142] 0 0
Switzerland
State/province [142] 0 0
Münsterlingen
Country [143] 0 0
Taiwan
State/province [143] 0 0
New Taipei
Country [144] 0 0
Taiwan
State/province [144] 0 0
Taichung
Country [145] 0 0
Taiwan
State/province [145] 0 0
Taipei
Country [146] 0 0
Turkey
State/province [146] 0 0
Adana
Country [147] 0 0
Turkey
State/province [147] 0 0
Ankara
Country [148] 0 0
Turkey
State/province [148] 0 0
Istanbul
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Falkirk
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Glasgow City
Country [151] 0 0
United Kingdom
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Kensington And Chelsea
Country [152] 0 0
United Kingdom
State/province [152] 0 0
London, City Of
Country [153] 0 0
United Kingdom
State/province [153] 0 0
Manchester
Country [154] 0 0
United Kingdom
State/province [154] 0 0
Wirral

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
BMS Study Connect www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See plan description
Available to whom?
See plan description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html


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/NCT06561386