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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/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
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
Secondary ID [1] 0 0
2017-003583-12
Secondary ID [2] 0 0
CA224-047
Universal Trial Number (UTN)
Trial acronym
RELATIVITY-047
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
Other interventions - Relatlimab
Other interventions - Nivolumab

Experimental: Arm A: Relatlimab + Nivolumab - Combination

Experimental: Arm B: Nivolumab - Monotherapy


Other interventions: Relatlimab
Specified dose on specified day

Other interventions: Nivolumab
Specified dose on specified days
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
From randomization to date of first documented tumor progression or death (up to approximately 33 months)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From randomization to the date of death (up to approximately 3 years)
Secondary outcome [2] 0 0
Overall Response Rate (ORR)
Timepoint [2] 0 0
From randomization up to approximately 3 years

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

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 2/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
11/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/12/2025
Actual
Sample size
Target
Accrual to date
Final
714
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Local Institution - 0042 - North Sydney
Recruitment hospital [2] 0 0
Local Institution - 0043 - Waratah
Recruitment hospital [3] 0 0
Local Institution - 0041 - Greenslopes
Recruitment hospital [4] 0 0
Local Institution - 0045 - Southport
Recruitment hospital [5] 0 0
Local Institution - 0133 - Bedford Park
Recruitment hospital [6] 0 0
Local Institution - 0044 - Murdoch
Recruitment postcode(s) [1] 0 0
2060 - North Sydney
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
4120 - Greenslopes
Recruitment postcode(s) [4] 0 0
4215 - Southport
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment outside Australia
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Arizona
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Avon
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Dumfries & Galloway
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Greater London
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Inverness-shire

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 determine whether relatlimab in combination with nivolumab is
more effective than nivolumab by itself in treating unresectable melanoma or melanoma that
has spread.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03470922
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/NCT03470922