Clinical trial NCT05002569: A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma
Official title: A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab + Relatlimab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV Melanoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Melanoma
Keywords: Melanoma
Relatlimab
Nivolumab
Opdivo
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-08-12
Enrollment: 1190
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 assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.


Eligibility criteria: Inclusion Criteria:

* Must have been diagnosed with either Stage IIIA (\> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by American Joint Committee on Cancer (AJCC) v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible
* Participants ≥ 18 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. Adolescent participants between 12 and \< 18 years of age must have a Lansky/Karnofsky performance score ≥ 80%
* Complete resection must be performed within 90 days prior to randomization
* All participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization
* Tumor tissue must be provided for biomarker analyses

Exclusion Criteria:

* History of ocular melanoma
* Untreated/unresected CNS metastases or leptomeningeal metastases
* Active, known, or suspected autoimmune disease
* Participants with serious or uncontrolled medical disorder
* Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted
* Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks prior to screening
* History of myocarditis, regardless of etiology.

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Recurrence-Free Survival (RFS) time per Investigator assessment
timeFrame: Approximately 52 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Approximately 90 months
measure: Distant Metastasis-Free Survival (DMFS) time per Investigator assessment
timeFrame: Approximately 90 months
measure: Incidence of Adverse Events (AEs)
timeFrame: 30 days from participant's last dose
measure: Severity of AEs
timeFrame: 30 days from participant's last dose
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: 30 days from participant's last dose
measure: Severity of SAEs
timeFrame: 30 days from participant's last dose
measure: Incidence of AEs leading to discontinuation (DC)
timeFrame: 30 days from participant's last dose
measure: Severity of AEs leading to DC
timeFrame: 30 days from participant's last dose
measure: Incidence of immune-mediated AEs (IMAEs)
timeFrame: 135 days from participant's last dose
measure: Severity of IMAEs
timeFrame: 135 days from participant's last dose
measure: Incidence of drug related AEs
timeFrame: 30 days from participant's last dose
measure: Severity of drug related AEs
timeFrame: 30 days from participant's last dose
measure: Incidence of deaths
timeFrame: 30 days from participant's last dose
measure: Incidence of clinically significant changes in clinical laboratory values: Hematology tests
timeFrame: 30 days from participant's last dose
measure: Incidence of clinically significant changes in clinical laboratory values: Chemistry tests
timeFrame: 30 days from participant's last dose
measure: Progression-Free Survival 2 (PFS2)
timeFrame: Approximately 52 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 0176
state: Alabama
city: Springdale
country: United States
facility: Local Institution - 0164
state: Arkansas
city: Los Angeles
country: United States
facility: Local Institution - 0200
state: California
city: Palo Alto
country: United States
facility: Local Institution - 0185
state: California
city: San Francisco
country: United States
facility: Local Institution - 0162
state: California
city: Santa Monica
country: United States
facility: Saint John's Cancer Institute
state: California
city: Aurora
country: United States
facility: Local Institution - 0138
state: Colorado
city: Washington
country: United States
facility: Local Institution - 0166
state: District of Columbia
city: Miami
country: United States
facility: Local Institution - 0243
state: Florida
city: Miami
country: United States
facility: Washington University School Of Medicine
state: Florida
city: Pensacola
country: United States
facility: Local Institution - 0179
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
state: Florida
city: Atlanta
country: United States
facility: Local Institution - 0191
state: Georgia
city: Atlanta
country: United States
facility: Local Institution - 0148
state: Georgia
city: Chicago
country: United States
facility: Local Institution - 0202
state: Illinois
city: Peoria
country: United States
facility: Local Institution - 0177
state: Illinois
city: Fort Wayne
country: United States
facility: Local Institution - 0223
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa-Holden Comprehensive Cancer Center
state: Iowa
city: Westwood
country: United States
facility: Local Institution - 0178
state: Kansas
city: Boston
country: United States
facility: Dana-Farber Cancer Institute-Melanoma
state: Massachusetts
city: Ann Arbor
country: United States
facility: Local Institution - 0258
state: Michigan
city: Grand Rapids
country: United States
facility: Local Institution
state: Michigan
city: Minneapolis
country: United States
facility: Local Institution - 0133
state: Minnesota
city: Hackensack
country: United States
facility: Local Institution - 0139
state: New Jersey
city: Morristown
country: United States
facility: Local Institution - 0206
state: New Jersey
city: New York
country: United States
facility: Local Institution - 0140
state: New York
city: New York
country: United States
facility: Icahn School Of Medicine At Mount Sinai
state: New York
city: New York
country: United States
facility: Local Institution - 0210
state: New York
city: Charlotte
country: United States
facility: Local Institution - 0130
state: North Carolina
city: Durham
country: United States
facility: Local Institution - 0145
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Local Institution - 0141
state: Ohio
city: Columbus
country: United States
facility: The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
state: Ohio
city: Allentown
country: United States
facility: Local Institution - 0267
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 0125
state: Pennsylvania
city: Charleston
country: United States
facility: Local Institution - 0171
state: South Carolina
city: Germantown
country: United States
facility: Local Institution - 0147
state: Tennessee
city: Nashville
country: United States
facility: Local Institution - 0183
state: Tennessee
city: Austin
country: United States
facility: Local Institution - 0146
state: Texas
city: Dallas
country: United States
facility: Local Institution - 0163
state: Texas
city: Houston
country: United States
facility: Local Institution - 0172
state: Texas
city: Fairfax
country: United States
facility: Local Institution - 0137
state: Virginia
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Local Institution - 0003
state: Buenos Aires
city: Caba
country: Argentina
facility: Local Institution - 0001
state: Distrito Federal
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Local Institution - 0005
state: Distrito Federal
city: Ciudad de Buenos Aires
country: Argentina
facility: Local Institution - 0002
state: Distrito Federal
city: Cordoba
country: Argentina
facility: Local Institution - 0004
city: Waratah
country: Australia
facility: Local Institution - 0030
state: New South Wales
city: Westmead
country: Australia
facility: Local Institution - 0252
state: New South Wales
city: Wollstonecraft
country: Australia
facility: Local Institution - 0032
state: New South Wales
city: Tiwi
country: Australia
facility: Local Institution - 0254
state: Northern Territory
city: Brisbane
country: Australia
facility: Local Institution - 0028
state: Queensland
city: Southport
country: Australia
facility: Local Institution - 0027
state: Queensland
city: Woodville
country: Australia
facility: Local Institution - 0250
state: South Australia
city: Ballarat
country: Australia
facility: Local Institution - 0035
state: Victoria
city: Heidelberg
country: Australia
facility: Local Institution - 0253
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution - 0031
state: Victoria
city: Murdoch
country: Australia
facility: Local Institution - 0251
state: Western Australia
city: Perth
country: Australia
facility: Local Institution - 0029
state: Western Australia
city: Graz
country: Austria
facility: Local Institution - 0082
state: Steiermark
city: Salzburg
country: Austria
facility: Local Institution - 0086
city: Vienna
country: Austria
facility: Local Institution - 0084
city: Brussels
country: Belgium
facility: Local Institution - 0110
city: Bruxelles
country: Belgium
facility: Local Institution - 0105
city: Liège
country: Belgium
facility: Local Institution - 0109
city: Wilrijk
country: Belgium
facility: Local Institution - 0106
city: Salvador
country: Brazil
facility: Local Institution - 0071
state: Bahia
city: Fortaleza
country: Brazil
facility: Local Institution - 0072
state: Ceara
city: Vitória
country: Brazil
facility: Local Institution - 0068
state: Espirito Santo
city: Belo Horizonte
country: Brazil
facility: Local Institution - 0047
state: Minas Gerais
city: Ijui
country: Brazil
facility: Local Institution - 0056
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution - 0257
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution - 0049
state: RIO Grande DO SUL
city: Santa Cruz do Sul
country: Brazil
facility: Local Institution - 0048
state: RIO Grande DO SUL
city: Barretos
country: Brazil
facility: Local Institution - 0070
state: SAO Paulo
city: Rio de Janeiro
country: Brazil
facility: Local Institution - 0058
city: Edmonton
country: Canada
facility: Local Institution - 0155
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution - 0175
state: British Columbia
city: Halifax
country: Canada
facility: Local Institution - 0197
state: Nova Scotia
city: Montreal
country: Canada
facility: Local Institution - 0158
state: Quebec
city: Montréal
country: Canada
facility: Local Institution - 0159
state: Quebec
city: Quebec City
country: Canada
facility: Local Institution - 0160
state: Quebec
city: Sherbrooke
country: Canada
facility: Local Institution - 0198
state: Quebec
city: Santiago
country: Chile
facility: Local Institution - 0013
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0006
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0014
state: Metropolitana
city: Hefei
country: China
facility: Local Institution - 0221
state: Anhui
city: Beijing
country: China
facility: Local Institution - 0259
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0261
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0214
state: Beijing
city: Chongqing
country: China
facility: Local Institution - 0241
state: Chongqing
city: Fuzhou City
country: China
facility: Local Institution - 0245
state: Fujian
city: Guangzhou
country: China
facility: Local Institution - 0217
state: Guangdong
city: Zhengzhou Shi
country: China
facility: Local Institution - 0226
state: Henan
city: Wuhan
country: China
facility: Local Institution - 0237
state: Hubei
city: Wuhan
country: China
facility: Local Institution - 0239
state: Hubei
city: Changsha Shi
country: China
facility: Local Institution - 0234
state: Hunan
city: Nanjing
country: China
facility: Local Institution - 0215
state: Jiangsu
city: Nanjing
country: China
facility: Local Institution - 0225
state: Jiangsu
city: Nanchang
country: China
facility: Local Institution - 0224
state: Jiangxi
city: Changchun
country: China
facility: Local Institution - 0219
state: Jilin
city: Shenyang
country: China
facility: Local Institution - 0242
state: Liaoning
city: Chengdu
country: China
facility: Local Institution - 0230
state: Sichuan
city: Tianjin
country: China
facility: Local Institution - 0263
state: Tianjin
city: Urumqi
country: China
facility: Local Institution - 0228
state: Xinjiang
city: Kunming
country: China
facility: Local Institution - 0222
state: Yunnan
city: Hangzhou
country: China
facility: Local Institution - 0220
state: Zhejiang
city: Hangzhou
country: China
facility: Local Institution - 0216
state: Zhejiang
city: Taiyuan
country: China
facility: Local Institution - 0244
city: Brno
country: Czechia
facility: Local Institution - 0156
city: Hradec Kralove
country: Czechia
facility: Local Institution - 0091
city: Ostrava
country: Czechia
facility: Local Institution - 0026
city: Prague
country: Czechia
facility: Local Institution - 0062
city: Aarhus
country: Denmark
facility: Local Institution - 0016
state: Midtjylland
city: Aalborg
country: Denmark
facility: Local Institution - 0022
city: Copenhagen
country: Denmark
facility: Local Institution - 0018
city: Odense
country: Denmark
facility: Local Institution - 0020
city: Helsinki
country: Finland
facility: Helsinki University Hospital Adult ICU PPDS
city: Tampere
country: Finland
facility: Local Institution - 0019
city: Turku
country: Finland
facility: Local Institution - 0015
city: Villejuif
country: France
facility: Local Institution - 0040
state: Val-de-Marne
city: Dijon
country: France
facility: Local Institution - 0043
city: Marseille
country: France
facility: Local Institution - 0044
city: Nantes
country: France
facility: Local Institution - 0039
city: Paris
country: France
facility: Local Institution - 0042
city: Pierre-Bénite
country: France
facility: Local Institution - 0041
city: Toulouse
country: France
facility: Local Institution - 0046
city: Tübingen
country: Germany
facility: Local Institution - 0092
state: Baden-Württemberg
city: Hannover
country: Germany
facility: Local Institution - 0079
state: Lower Saxony
city: Buxtehude
country: Germany
facility: Local Institution - 0073
city: Dresden
country: Germany
facility: Local Institution - 0077
city: Erlangen
country: Germany
facility: Local Institution - 0074
city: Essen
country: Germany
facility: Local Institution - 0131
city: Gera
country: Germany
facility: Local Institution - 0081
city: Heidelberg
country: Germany
facility: Local Institution - 0075
city: Lübeck
country: Germany
facility: Local Institution - 0078
city: Minden
country: Germany
facility: Local Institution - 0083
city: Munich
country: Germany
facility: Local Institution - 0076
city: Wuerzburg
country: Germany
facility: Local Institution - 0080
city: Athens
country: Greece
facility: Local Institution - 0114
city: Neo Faliro
country: Greece
facility: Local Institution - 0113
city: Thessaloniki
country: Greece
facility: Local Institution - 0112
city: Petah Tikva
country: Israel
facility: Local Institution - 0199
state: HaMerkaz
city: Jerusalem
country: Israel
facility: Local Institution - 0118
state: Yerushalayim
city: Afula
country: Israel
facility: Local Institution - 0116
city: Ramat Gan
country: Israel
facility: Local Institution - 0117
city: Milano
country: Italy
facility: Local Institution - 0123
city: Milan
country: Italy
facility: Local Institution - 0115
city: Milan
country: Italy
facility: Local Institution - 0268
city: Napoli
country: Italy
facility: Local Institution - 0119
city: Padova
country: Italy
facility: Local Institution - 0120
city: Perugia
country: Italy
facility: Local Institution - 0122
city: Siena
country: Italy
facility: Local Institution - 0121
city: Benito Juarez
country: Mexico
facility: Local Institution - 0100
state: Distrito Federal
city: Zapopan
country: Mexico
facility: Local Institution - 0021
state: Jalisco
city: Mexico
country: Mexico
facility: Local Institution - 0093
state: Nuevo LEON
city: Oaxaca
country: Mexico
facility: Local Institution - 0098
city: Lørenskog
country: Norway
facility: Local Institution - 0009
state: Akershus
city: Stavanger
country: Norway
facility: Local Institution - 0023
state: Rogaland
city: Oslo
country: Norway
facility: Local Institution - 0017
city: Coimbra
country: Portugal
facility: Local Institution - 0249
city: Brasov
country: Romania
facility: Local Institution - 0170
city: Cluj
country: Romania
facility: Local Institution - 0065
city: Craiova
country: Romania
facility: Local Institution - 0066
city: Floresti/ Cluj
country: Romania
facility: Local Institution - 0064
city: Badajoz
country: Spain
facility: Local Institution - 0188
city: Barcelona
country: Spain
facility: Local Institution - 0201
city: Granada
country: Spain
facility: Local Institution - 0153
city: Madrid
country: Spain
facility: Local Institution - 0150
city: San Sebastian
country: Spain
facility: Local Institution - 0151
city: València
country: Spain
facility: Local Institution - 0152
city: Gothenburg
country: Sweden
facility: Local Institution - 0010
city: Lund
country: Sweden
facility: Local Institution - 0011
city: Solna
country: Sweden
facility: Local Institution - 0012
city: Basel
country: Switzerland
facility: Local Institution - 0085
city: Chur
country: Switzerland
facility: Local Institution - 0087
city: Zürich
country: Switzerland
facility: Local Institution - 0090
city: Nottingham
country: United Kingdom
facility: Local Institution - 0101
state: Nottinghamshire
city: Bristol
country: United Kingdom
facility: Local Institution - 0102
city: Glasgow
country: United Kingdom
facility: Local Institution - 0187
city: Newcastle upon Tyne
country: United Kingdom
facility: Local Institution - 0154
city: Oxford
country: United Kingdom
facility: Local Institution - 0232
city: Southampton
country: United Kingdom
facility: Local Institution - 0127
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: