Clinical trial NCT03470922: A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Melanoma
Keywords: Cancer
Advanced Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-03-20
Enrollment: 714
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From randomization to date of first documented tumor progression or death (up to approximately 33 months)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From randomization to the date of death (up to approximately 3 years)
measure: Overall Response Rate (ORR)
timeFrame: From randomization up to approximately 3 years
Other outcomes:
measure: The Number of Participants Experiencing Adverse Events (AEs)
timeFrame: From first dose to 30 days after last dose of study therapy (up to approximately 33 months)
measure: The Number of Participants Experiencing Serious Adverse Events (SAEs)
timeFrame: From first dose to 30 days after last dose of study therapy (up to approximately 33 months)
measure: The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
timeFrame: From first dose to 30 days after last dose of study therapy (up to approximately 33 months)
measure: The Number of Participant Deaths in the Study
timeFrame: From first dose up to approximately 33 months
measure: The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests
timeFrame: From first dose to 30 days after last dose of study therapy (up to approximately 33 months)
measure: The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests
timeFrame: From first dose to 30 days after last dose of study therapy (up to approximately 33 months)
Locations:
city: Tucson
country: United States
facility: Local Institution - 0010
state: Arizona
city: Los Angeles
country: United States
facility: Local Institution - 0020
state: California
city: San Luis Obispo
country: United States
facility: Coastal Integrative Cancer Care
state: California
city: Santa Barbara
country: United States
facility: Local Institution - 0116
state: California
city: Washington
country: United States
facility: Local Institution - 0012
state: District of Columbia
city: Jacksonville
country: United States
facility: Local Institution - 0013
state: Florida
city: Orlando
country: United States
facility: Local Institution - 0117
state: Florida
city: Tampa
country: United States
facility: Local Institution - 0007
state: Florida
city: Atlanta
country: United States
facility: Local Institution - 0038
state: Georgia
city: Chicago
country: United States
facility: Local Institution - 0016
state: Illinois
city: Fort Wayne
country: United States
facility: Local Institution - 0114
state: Indiana
city: Baltimore
country: United States
facility: Local Institution - 0077
state: Maryland
city: Baltimore
country: United States
facility: Local Institution - 0120
state: Maryland
city: Boston
country: United States
facility: Local Institution - 0014
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0134
state: Massachusetts
city: Ann Arbor
country: United States
facility: Local Institution - 0015
state: Michigan
city: Minneapolis
country: United States
facility: Local Institution - 0009
state: Minnesota
city: Rochester
country: United States
facility: Local Institution - 0011
state: Minnesota
city: Charlotte
country: United States
facility: Local Institution - 0018
state: North Carolina
city: Allentown
country: United States
facility: Local Institution - 0019
state: Pennsylvania
city: Dallas
country: United States
facility: Local Institution - 0076
state: Texas
city: Houston
country: United States
facility: Local Institution - 0008
state: Texas
city: Buenos Aires
country: Argentina
facility: Local Institution - 0135
state: Distrito Federal
city: Capital Federal
country: Argentina
facility: Local Institution - 0002
state: Distrito Federal
city: Buenos Aires
country: Argentina
facility: Local Institution - 0004
city: Buenos Aires
country: Argentina
facility: Local Institution - 0005
city: Ciudad Autónoma De Buenos Aires
country: Argentina
facility: Local Institution - 0003
city: North Sydney
country: Australia
facility: Local Institution - 0042
state: New South Wales
city: Waratah
country: Australia
facility: Local Institution - 0043
state: New South Wales
city: Greenslopes
country: Australia
facility: Local Institution - 0041
state: Queensland
city: Southport
country: Australia
facility: Local Institution - 0045
state: Queensland
city: Bedford Park
country: Australia
facility: Local Institution - 0133
state: South Australia
city: Murdoch
country: Australia
facility: Local Institution - 0044
state: Western Australia
city: Graz
country: Austria
facility: Local Institution - 0036
state: Steiermark
city: Salzburg
country: Austria
facility: Local Institution - 0037
city: Wien
country: Austria
facility: Local Institution - 0035
city: Brussels
country: Belgium
facility: Local Institution - 0047
city: Bruxelles
country: Belgium
facility: Local Institution - 0049
city: Gent
country: Belgium
facility: Local Institution - 0048
city: Belo Horizonte
country: Brazil
facility: Local Institution - 0058
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: Local Institution - 0057
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution - 0061
state: RIO Grande DO SUL
city: Santa Cruz do Sul
country: Brazil
facility: Local Institution - 0073
state: RIO Grande DO SUL
city: São Paulo
country: Brazil
facility: Local Institution - 0063
state: SAO Paulo
city: Rio De Janiro
country: Brazil
facility: Local Institution - 0059
city: Sao Paulo
country: Brazil
facility: Local Institution - 0060
city: Sao Paulo
country: Brazil
facility: Local Institution - 0062
city: Halifax
country: Canada
facility: Local Institution - 0124
state: Nova Scotia
city: Ottawa
country: Canada
facility: Local Institution - 0068
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0128
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 0123
state: Quebec
city: Montreal
country: Canada
facility: Local Institution - 0075
state: Quebec
city: Santiago
country: Chile
facility: Local Institution - 0001
state: Metropolitana
city: Medellín
country: Colombia
facility: Local Institution - 0096
state: Antioquia
city: Bogota
country: Colombia
facility: Local Institution - 0095
city: Aarhus N
country: Denmark
facility: Local Institution - 0105
state: Midtjylland
city: Herlev
country: Denmark
facility: Local Institution - 0103
city: Odense
country: Denmark
facility: Local Institution - 0104
city: Helsinki
country: Finland
facility: Local Institution - 0100
state: Uusimaa
city: Oulu
country: Finland
facility: Local Institution - 0102
city: Tampere
country: Finland
facility: Local Institution - 0119
city: Turku
country: Finland
facility: Local Institution - 0101
city: Rennes
country: France
facility: Local Institution - 0084
state: Ille-et-Vilaine
city: Amiens
country: France
facility: Local Institution - 0079
state: Somme
city: Bordeaux Cedex
country: France
facility: Local Institution - 0080
city: Lille
country: France
facility: Local Institution - 0085
city: Marseille
country: France
facility: Local Institution - 0081
city: Paris
country: France
facility: Local Institution - 0083
city: Pierre-Benite
country: France
facility: Local Institution - 0078
city: Poitiers
country: France
facility: Local Institution - 0082
city: Heidelberg
country: Germany
facility: Local Institution - 0132
state: Baden-Württemberg
city: Tübingen
country: Germany
facility: Local Institution - 0131
state: Baden-Württemberg
city: Quedlinburg
country: Germany
facility: Local Institution - 0071
state: Sachsen-Anhalt
city: Buxtehude
country: Germany
facility: Local Institution - 0032
city: Erfurt
country: Germany
facility: Local Institution - 0030
city: Essen
country: Germany
facility: Local Institution - 0027
city: Hannover
country: Germany
facility: Local Institution - 0033
city: Homburg / Saar
country: Germany
facility: Local Institution - 0074
city: Köln
country: Germany
facility: Local Institution - 0029
city: Lubeck
country: Germany
facility: Local Institution - 0028
city: Mannheim
country: Germany
facility: Local Institution - 0072
city: Muenchen
country: Germany
facility: Local Institution - 0034
city: Wuerzburg
country: Germany
facility: Local Institution - 0031
city: Athens
country: Greece
facility: Local Institution - 0064
city: Thessaloniki
country: Greece
facility: Local Institution - 0065
city: Haifa
country: Israel
facility: Local Institution - 0086
city: Jerusalem
country: Israel
facility: Local Institution - 0088
city: Ramat-gan
country: Israel
facility: Local Institution - 0087
city: Torino
country: Italy
facility: Local Institution - 0111
state: Piemonte
city: Bergamo
country: Italy
facility: Local Institution - 0109
city: Milano
country: Italy
facility: Local Institution - 0108
city: Napoli
country: Italy
facility: Local Institution - 0106
city: Padova
country: Italy
facility: Local Institution - 0110
city: Siena
country: Italy
facility: Local Institution - 0107
city: Zapopan
country: Mexico
facility: Local Institution - 0094
state: Jalisco
city: Monterrey
country: Mexico
facility: Local Institution - 0091
state: Nuevo LEON
city: Cancún
country: Mexico
facility: Local Institution - 0093
state: Quintana Roo
city: Mérida
country: Mexico
facility: Local Institution - 0092
state: Yucatán
city: Veracruz
country: Mexico
facility: Local Institution - 0129
city: Dunedin
country: New Zealand
facility: Local Institution - 0090
city: Hamilton
country: New Zealand
facility: Local Institution - 0125
city: Tauranga
country: New Zealand
facility: Local Institution - 0089
city: Oslo
country: Norway
facility: Local Institution - 0121
city: Poznan
country: Poland
facility: Local Institution - 0040
city: Warszawa
country: Poland
facility: Local Institution - 0039
city: Cluj-Napoca
country: Romania
facility: Local Institution - 0070
state: Cluj
city: Bucharest
country: Romania
facility: Local Institution - 0066
city: Craiova
country: Romania
facility: Local Institution - 0067
city: Iasi
country: Romania
facility: Local Institution - 0069
city: Krasnodar
country: Russian Federation
facility: Local Institution - 0113
city: Krasnoyarsk
country: Russian Federation
facility: Local Institution - 0127
city: Moscow
country: Russian Federation
facility: Local Institution - 0112
city: A Coruña
country: Spain
facility: Local Institution - 0023
city: Barcelona
country: Spain
facility: Local Institution - 0024
city: Barcelona
country: Spain
facility: Local Institution - 0025
city: Madrid
country: Spain
facility: Local Institution - 0026
city: San Sabastian Gipuzkoa
country: Spain
facility: Local Institution - 0021
city: Sevilla
country: Spain
facility: Local Institution - 0022
city: Goteborg
country: Sweden
facility: Local Institution - 0098
city: Lund
country: Sweden
facility: Local Institution - 0099
city: Solna
country: Sweden
facility: Local Institution - 0118
city: Uppsala
country: Sweden
facility: Local Institution - 0122
city: Bristol
country: United Kingdom
facility: Local Institution - 0052
state: Avon
city: Glasgow
country: United Kingdom
facility: Local Institution - 0054
state: Dumfries & Galloway
city: Swansea
country: United Kingdom
facility: Local Institution - 0056
state: Glamorgan
city: London
country: United Kingdom
facility: Local Institution - 0051
state: Greater London
city: Inverness
country: United Kingdom
facility: Local Institution - 0126
state: Inverness-shire
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.