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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03470922
Registration number
NCT03470922
Ethics application status
Date submitted
14/03/2018
Date registered
20/03/2018
Date last updated
21/09/2023
Titles & IDs
Public title
A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma
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Scientific title
A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Metastatic or Unresectable Melanoma
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Secondary ID [1]
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2017-003583-12
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Secondary ID [2]
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CA224-047
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Universal Trial Number (UTN)
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Trial acronym
RELATIVITY-047
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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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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: Other - Relatlimab
Treatment: Other - Nivolumab
Experimental: Arm A: Relatlimab + Nivolumab - Combination
Experimental: Arm B: Nivolumab - Monotherapy
Treatment: Other: Relatlimab
Specified dose on specified day
Treatment: Other: Nivolumab
Specified dose on specified days
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Intervention code [1]
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Treatment: Other
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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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Progression Free Survival (PFS)
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Assessment method [1]
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Progression Free Survival (PFS) is defined as the time between the date of randomization and the date of first documented tumor progression, assessed by a blinded independent central review (BICR) (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Subjects who die without a reported progression will be considered to have progressed on the date of their death.
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Timepoint [1]
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From randomization to date of first documented tumor progression or death (up to approximately 33 months)
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. For subjects that are alive, their survival time will be censored at the date of last contact ("last known alive date").
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Timepoint [1]
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From randomization to the date of death (up to approximately 3 years)
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Secondary outcome [2]
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Overall Response Rate (ORR)
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Assessment method [2]
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Objective response rate (ORR) is defined as the number of randomized subjects who achieve a best response of complete response (CR) or partial response (PR) based on BICR assessments (using RECIST v1.1 criteria).
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Timepoint [2]
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From randomization up to approximately 3 years
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Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
* Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the AJCC staging system
* Participants must not have had prior systemic anticancer therapy for unresectable or metastatic melanoma
* Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses
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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
* Participants must not have active brain metastases or leptomeningeal metastases
* Participants must not have uveal melanoma
* Participants must not have an active, known, or suspected autoimmune disease
Other protocol defined inclusion/exclusion criteria could 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
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not 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
11/04/2018
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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
16/12/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
714
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
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Recruitment hospital [1]
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Local Institution - 0042 - North Sydney
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Local Institution - 0043 - Waratah
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Local Institution - 0041 - Greenslopes
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Local Institution - 0045 - Southport
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Local Institution - 0133 - Bedford Park
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Local Institution - 0044 - Murdoch
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2060 - North Sydney
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2298 - Waratah
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4120 - Greenslopes
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4215 - Southport
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5042 - Bedford Park
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6150 - Murdoch
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Funding & Sponsors
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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 determine whether relatlimab in combination with nivolumab is more effective than nivolumab by itself in treating unresectable melanoma or melanoma that has spread.
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Trial website
https://clinicaltrials.gov/study/NCT03470922
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Trial related presentations / publications
Tawbi HA, Schadendorf D, Lipson EJ, Ascierto PA, Matamala L, Castillo Gutierrez E, Rutkowski P, Gogas HJ, Lao CD, De Menezes JJ, Dalle S, Arance A, Grob JJ, Srivastava S, Abaskharoun M, Hamilton M, Keidel S, Simonsen KL, Sobiesk AM, Li B, Hodi FS, Long GV; RELATIVITY-047 Investigators. Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma. N Engl J Med. 2022 Jan 6;386(1):24-34. doi: 10.1056/NEJMoa2109970.
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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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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/22/NCT03470922/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/22/NCT03470922/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03470922
Download to PDF