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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05625399
Registration number
NCT05625399
Ethics application status
Date submitted
15/11/2022
Date registered
22/11/2022
Titles & IDs
Public title
A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma
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Scientific title
A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination Versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants With Previously Untreated Metastatic or Unresectable Melanoma
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Secondary ID [1]
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2022-000575-39
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Secondary ID [2]
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CA224-127
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Universal Trial Number (UTN)
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Trial acronym
RELATIVITY-127
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma
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0
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Condition category
Condition code
Cancer
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0
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Nivolumab + Relatlimab
Treatment: Drugs - rHuPH20
Experimental: Nivolumab + Relatlimab FDC SC -
Active comparator: Nivolumab + Relatlimab FDC IV -
Treatment: Drugs: Nivolumab + Relatlimab
Specified dose on specified days
Treatment: Drugs: rHuPH20
Specified dose on specified days
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time-averaged serum concentration over 28 days after the first dose (Cavgd28) of Nivolumab
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Assessment method [1]
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Timepoint [1]
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Up to 28 days
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Primary outcome [2]
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Trough serum concentration at steady state (Cminss) of Nivolumab
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Assessment method [2]
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0
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Timepoint [2]
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Up to 4 months
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Primary outcome [3]
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Cavgd28 of Relatlimab
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Assessment method [3]
0
0
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Timepoint [3]
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Up to 28 days
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Primary outcome [4]
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Cminss of Relatlimab
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Assessment method [4]
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Timepoint [4]
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Up to 4 months
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Secondary outcome [1]
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Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) per RECIST v1.1
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Assessment method [1]
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0
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Timepoint [1]
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Up to approximately 3 years
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Secondary outcome [2]
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0
Trough serum concentration at Day 28 after the first dose (Cmind28) of Nivolumab and Relatlimab
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Assessment method [2]
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0
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Timepoint [2]
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0
Up to 28 days
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Secondary outcome [3]
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Peak serum concentration after the first dose (Cmax1) of Nivolumab and Relatlimab
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Assessment method [3]
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0
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Timepoint [3]
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Up to 28 days
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Secondary outcome [4]
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Time to Cmax1 (Tmax1) of Nivolumab and Relatlimab
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Assessment method [4]
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0
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Timepoint [4]
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Up to 28 days
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Secondary outcome [5]
0
0
Peak serum concentration at steady state (Cmaxss) of Nivolumab and Relatlimab
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Assessment method [5]
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0
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Timepoint [5]
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Up to 4 months
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Secondary outcome [6]
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0
Time-averaged serum concentration at steady state (Cavgss) of Nivolumab and Relatlimab
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Assessment method [6]
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0
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Timepoint [6]
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Up to 4 months
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Secondary outcome [7]
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Duration of Response (DOR) by BICR per RECIST v1.1
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Assessment method [7]
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0
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Timepoint [7]
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Up to approximately 3 years
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Secondary outcome [8]
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Disease Control Rate (DCR) by BICR per RECIST v1.1
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Assessment method [8]
0
0
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Timepoint [8]
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Up to approximately 3 years
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Secondary outcome [9]
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Time to Response (TTR), by BICR per RECIST v1.1
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Assessment method [9]
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0
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Timepoint [9]
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Up to approximately 3 years
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Secondary outcome [10]
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Objective Response Rate (ORR) by Investigator per RECIST v1.1
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Assessment method [10]
0
0
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Timepoint [10]
0
0
Up to approximately 3 years
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Secondary outcome [11]
0
0
DOR by Investigator per RECIST v1.1
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Assessment method [11]
0
0
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Timepoint [11]
0
0
Up to approximately 3 years
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Secondary outcome [12]
0
0
DCR by Investigator per RECIST v1.1
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Assessment method [12]
0
0
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Timepoint [12]
0
0
Up to approximately 3 years
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Secondary outcome [13]
0
0
TTR by Investigator per RECIST v1.1
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Assessment method [13]
0
0
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Timepoint [13]
0
0
Up to approximately 3 years
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Secondary outcome [14]
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Progression Free Survival (PFS) by BICR and Investigator per RECIST v1.1
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Assessment method [14]
0
0
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Timepoint [14]
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Up to approximately 3 years
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Secondary outcome [15]
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Overall Survival
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Assessment method [15]
0
0
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Timepoint [15]
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Up to approximately 3 years
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Secondary outcome [16]
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Number of Participants with Adverse Events (AEs)
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Assessment method [16]
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0
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Timepoint [16]
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Up to approximately 3 years
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Secondary outcome [17]
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Change from Baseline in Functional Assessment of Cancer Therapy - Melanoma Subscale (FACT-MS)
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Assessment method [17]
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0
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Timepoint [17]
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Up to approximately 3 years
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Eligibility
Key inclusion criteria
Inclusion Criteria
* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of = 1/Lansky Performance Score = 80% for adolescents (= 12 to < 18 years of age).
* Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the American Joint Committee for Cancer (AJCC) staging system.
* Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
* Participants must be = 12 years of age. Participants who are = 12 years of age and < 18 years of age (adolescents) must weigh = 40 kg at the time of signing the informed consent (assent).
* Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the AJCC staging system (8th edition).
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
* Participants must not have ocular melanoma.
* Participants must not have a history of myocarditis, regardless of etiology.
* Participants must not have a condition requiring systemic treatment with either corticosteroids (>10 milligrams [mg] daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
* Other protocol-defined Inclusion/Exclusion criteria apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/03/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
28/02/2025
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Actual
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Sample size
Target
570
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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North Coast Area Health Service NCAHS - The North Coast Cancer Institute NCCI - Coffs Harbour Health Campus - Coffs Harbour
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Recruitment hospital [2]
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Orange Health Service - Orange
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Recruitment hospital [3]
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Port Macquarie Base Hospital - Port Macquarie
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Recruitment hospital [4]
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Riverina Cancer Care Centre - Wagga Wagga
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Recruitment hospital [5]
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Calvary Mater Newcastle - Waratah
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Recruitment hospital [6]
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Westmead Hospital - Westmead
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Recruitment hospital [7]
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University of Sydney - Melanoma Institute Australia MIA - Wollstonecraft
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Recruitment hospital [8]
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Sunshine Coast University Private Hospital - Birtinya
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Recruitment hospital [9]
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Local Institution - 0183 - Woodville South
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Recruitment hospital [10]
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Bendigo Health - Bendigo Cancer Centre - Bendigo
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Recruitment hospital [11]
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Box Hill Hospital-Eastern Health - Box Hill
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Recruitment hospital [12]
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Austin Hospital - Medical Oncology Unit - Heidelberg
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Recruitment hospital [13]
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The Alfred Hospital - Melbourne
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Recruitment hospital [14]
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Latrobe Regional Health - Traralgon
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Recruitment hospital [15]
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One Clinical Research - Nedlands
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Recruitment hospital [16]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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2450 - Coffs Harbour
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Recruitment postcode(s) [2]
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2800 - Orange
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Recruitment postcode(s) [3]
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2444 - Port Macquarie
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Recruitment postcode(s) [4]
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2650 - Wagga Wagga
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Recruitment postcode(s) [5]
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2298 - Waratah
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Recruitment postcode(s) [6]
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2145 - Westmead
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Recruitment postcode(s) [7]
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2065 - Wollstonecraft
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Recruitment postcode(s) [8]
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4575 - Birtinya
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Recruitment postcode(s) [9]
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5011 - Woodville South
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Recruitment postcode(s) [10]
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3550 - Bendigo
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Recruitment postcode(s) [11]
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3128 - Box Hill
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Recruitment postcode(s) [12]
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3084 - Heidelberg
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Recruitment postcode(s) [13]
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3004 - Melbourne
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Recruitment postcode(s) [14]
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3844 - Traralgon
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Recruitment postcode(s) [15]
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6009 - Nedlands
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Recruitment outside Australia
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Arizona
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Colorado
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Florida
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Maryland
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Nebraska
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New Jersey
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Ohio
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Germany
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Munchen
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Germany
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Nuernberg
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Germany
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Rostock
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Germany
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Tuebingen
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Israel
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Afula
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Jerusalem
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Israel
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Petah-Tikvah
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Israel
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Tel Hashomer
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Israel
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Tel-Aviv
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Italy
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Milan
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Italy
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Bari
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Italy
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Genova
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Italy
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Napoli
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Italy
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Perugia
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Italy
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Roma
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Italy
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Siena
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Jalisco
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Oaxaca
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Puebla
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Queretaro
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Norway
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Bodo
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Gralum
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Norway
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Lørenskog
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Norway
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Oslo
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Poland
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Bialystok
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Gliwice
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Warszawa
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Wroclaw
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Spain
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A Coruña
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Badalona
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Barcelona
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Granada
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Jaen
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Las Palmas de Gran Canaria
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Madrid
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Sevilla
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Valencia
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Zaragoza
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Sweden
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Stockholm
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Sweden
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Vastergotland
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Sweden
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Lund
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Uppsala
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Switzerland
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Bern
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Switzerland
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Chur
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Switzerland
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Lausanne
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United Kingdom
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Greater London
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United Kingdom
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Oxfordshire
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United Kingdom
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Strathclyde
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United Kingdom
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Tyne And Wear
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Ethics approval
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Summary
Brief summary
The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.
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Trial website
https://clinicaltrials.gov/study/NCT05625399
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Contact person for public queries
Name
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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Phone
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855-907-3286
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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 Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
See Plan Description
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Available to whom?
See Plan Description
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
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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/NCT05625399