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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
Date last updated
8/10/2024

Titles & IDs
Public title
A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma
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
Secondary ID [1] 0 0
2022-000575-39
Secondary ID [2] 0 0
CA224-127
Universal Trial Number (UTN)
Trial acronym
RELATIVITY-127
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: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time-averaged serum concentration over 28 days after the first dose (Cavgd28) of Nivolumab
Timepoint [1] 0 0
Up to 28 days
Primary outcome [2] 0 0
Trough serum concentration at steady state (Cminss) of Nivolumab
Timepoint [2] 0 0
Up to 4 months
Primary outcome [3] 0 0
Cavgd28 of Relatlimab
Timepoint [3] 0 0
Up to 28 days
Primary outcome [4] 0 0
Cminss of Relatlimab
Timepoint [4] 0 0
Up to 4 months
Secondary outcome [1] 0 0
Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) per RECIST v1.1
Timepoint [1] 0 0
Up to approximately 3 years
Secondary outcome [2] 0 0
Trough serum concentration at Day 28 after the first dose (Cmind28) of Nivolumab and Relatlimab
Timepoint [2] 0 0
Up to 28 days
Secondary outcome [3] 0 0
Peak serum concentration after the first dose (Cmax1) of Nivolumab and Relatlimab
Timepoint [3] 0 0
Up to 28 days
Secondary outcome [4] 0 0
Time to Cmax1 (Tmax1) of Nivolumab and Relatlimab
Timepoint [4] 0 0
Up to 28 days
Secondary outcome [5] 0 0
Peak serum concentration at steady state (Cmaxss) of Nivolumab and Relatlimab
Timepoint [5] 0 0
Up to 4 months
Secondary outcome [6] 0 0
Time-averaged serum concentration at steady state (Cavgss) of Nivolumab and Relatlimab
Timepoint [6] 0 0
Up to 4 months
Secondary outcome [7] 0 0
Duration of Response (DOR) by BICR per RECIST v1.1
Timepoint [7] 0 0
Up to approximately 3 years
Secondary outcome [8] 0 0
Disease Control Rate (DCR) by BICR per RECIST v1.1
Timepoint [8] 0 0
Up to approximately 3 years
Secondary outcome [9] 0 0
Time to Response (TTR), by BICR per RECIST v1.1
Timepoint [9] 0 0
Up to approximately 3 years
Secondary outcome [10] 0 0
Objective Response Rate (ORR) by Investigator per RECIST v1.1
Timepoint [10] 0 0
Up to approximately 3 years
Secondary outcome [11] 0 0
DOR by Investigator per RECIST v1.1
Timepoint [11] 0 0
Up to approximately 3 years
Secondary outcome [12] 0 0
DCR by Investigator per RECIST v1.1
Timepoint [12] 0 0
Up to approximately 3 years
Secondary outcome [13] 0 0
TTR by Investigator per RECIST v1.1
Timepoint [13] 0 0
Up to approximately 3 years
Secondary outcome [14] 0 0
Progression Free Survival (PFS) by BICR and Investigator per RECIST v1.1
Timepoint [14] 0 0
Up to approximately 3 years
Secondary outcome [15] 0 0
Overall Survival
Timepoint [15] 0 0
Up to approximately 3 years
Secondary outcome [16] 0 0
Number of Participants with Adverse Events (AEs)
Timepoint [16] 0 0
Up to approximately 3 years
Secondary outcome [17] 0 0
Change from Baseline in Functional Assessment of Cancer Therapy - Melanoma Subscale (FACT-MS)
Timepoint [17] 0 0
Up to approximately 3 years

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).
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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
6/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
570
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
North Coast Area Health Service NCAHS - The North Coast Cancer Institute NCCI - Coffs Harbour Health Campus - Coffs Harbour
Recruitment hospital [2] 0 0
Orange Health Service - Orange
Recruitment hospital [3] 0 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [4] 0 0
Riverina Cancer Care Centre - Wagga Wagga
Recruitment hospital [5] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [6] 0 0
Westmead Hospital - Westmead
Recruitment hospital [7] 0 0
University of Sydney - Melanoma Institute Australia MIA - Wollstonecraft
Recruitment hospital [8] 0 0
Sunshine Coast University Private Hospital - Birtinya
Recruitment hospital [9] 0 0
Local Institution - 0183 - Woodville South
Recruitment hospital [10] 0 0
Bendigo Health - Bendigo Cancer Centre - Bendigo
Recruitment hospital [11] 0 0
Box Hill Hospital-Eastern Health - Box Hill
Recruitment hospital [12] 0 0
Austin Hospital - Medical Oncology Unit - Heidelberg
Recruitment hospital [13] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [14] 0 0
Latrobe Regional Health - Traralgon
Recruitment hospital [15] 0 0
One Clinical Research - Nedlands
Recruitment hospital [16] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2800 - Orange
Recruitment postcode(s) [3] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [4] 0 0
2650 - Wagga Wagga
Recruitment postcode(s) [5] 0 0
2298 - Waratah
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment postcode(s) [7] 0 0
2065 - Wollstonecraft
Recruitment postcode(s) [8] 0 0
4575 - Birtinya
Recruitment postcode(s) [9] 0 0
5011 - Woodville South
Recruitment postcode(s) [10] 0 0
3550 - Bendigo
Recruitment postcode(s) [11] 0 0
3128 - Box Hill
Recruitment postcode(s) [12] 0 0
3084 - Heidelberg
Recruitment postcode(s) [13] 0 0
3004 - Melbourne
Recruitment postcode(s) [14] 0 0
3844 - Traralgon
Recruitment postcode(s) [15] 0 0
6009 - Nedlands
Recruitment outside Australia
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Tel Hashomer
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Israel
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Tel-Aviv
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Bari
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Genova
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Milan
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Napoli
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Roma
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Nuevo Leon
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Oaxaca
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Quintana Roo
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Puebla
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Queretaro
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Bodo
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Bialystok
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Gliwice
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Warszawa
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Wroclaw
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Gipuzkoa
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A Coruna
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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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Vastergotland
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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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Oxfordshire
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Strathclyde
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United Kingdom
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Tyne And Wear

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 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.
Trial website
https://clinicaltrials.gov/study/NCT05625399
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 Clinical Trials Contact Center www.BMSClinicalTrials.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05625399