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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 September 2023 |
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Main ID: |
NCT03470922 |
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Date of registration:
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14/03/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma
RELATIVITY-047 |
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Scientific title:
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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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Date of first enrolment:
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April 11, 2018 |
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Target sample size:
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714 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03470922 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Argentina
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Australia
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Austria
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Belgium
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Brazil
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Canada
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Chile
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Colombia
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Denmark
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Finland
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France
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Germany
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Greece
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Israel
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Italy
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Mexico
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New Zealand
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Norway
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Poland
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Romania
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Russian Federation
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Spain
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Sweden
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United Kingdom
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United States
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Contacts
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Name:
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Bristol-Myers Squibb |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Key inclusion & exclusion criteria
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- 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
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
Age minimum:
12 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Melanoma
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Intervention(s)
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Biological: Nivolumab
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Biological: Relatlimab
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Primary Outcome(s)
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Progression Free Survival (PFS)
[Time Frame: From randomization to date of first documented tumor progression or death (up to approximately 33 months)]
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Secondary Outcome(s)
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Overall Response Rate (ORR)
[Time Frame: From randomization up to approximately 3 years]
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Overall Survival (OS)
[Time Frame: From randomization to the date of death (up to approximately 3 years)]
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Secondary ID(s)
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CA224-047
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2017-003583-12
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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