Clinical trial NCT05625399: A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma
Official title: A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination Versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants With Previously Untreated Metastatic or Unresectable Melanoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Melanoma
Keywords: Nivolumab
Relatlimab
FDC
Melanoma
rHuPH20
OPDUALAG
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-11-22
Enrollment: 570
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 demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.


Eligibility criteria: Inclusion Criteria

* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% for adolescents (≥ 12 to \< 18 years of age).
* Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the American Joint Committee for Cancer (AJCC) staging system.
* Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
* Participants must be ≥ 12 years of age. Participants who are ≥ 12 years of age and \< 18 years of age (adolescents) must weigh ≥ 40 kg at the time of signing the informed consent (assent).
* Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the AJCC staging system (8th edition).

Exclusion Criteria

* Participants must not have ocular melanoma.
* Participants must not have a history of myocarditis, regardless of etiology.
* Participants must not have a condition requiring systemic treatment with either corticosteroids (\>10 milligrams \[mg\] daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \>10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Time-averaged serum concentration over 28 days after the first dose (Cavgd28) of Nivolumab
timeFrame: Up to 28 days
measure: Trough serum concentration at steady state (Cminss) of Nivolumab
timeFrame: Up to 4 months
measure: Cavgd28 of Relatlimab
timeFrame: Up to 28 days
measure: Cminss of Relatlimab
timeFrame: Up to 4 months
Secondary outcomes:
measure: Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) per RECIST v1.1
timeFrame: Up to approximately 3 years
measure: Trough serum concentration at Day 28 after the first dose (Cmind28) of Nivolumab and Relatlimab
timeFrame: Up to 28 days
measure: Peak serum concentration after the first dose (Cmax1) of Nivolumab and Relatlimab
timeFrame: Up to 28 days
measure: Time to Cmax1 (Tmax1) of Nivolumab and Relatlimab
timeFrame: Up to 28 days
measure: Peak serum concentration at steady state (Cmaxss) of Nivolumab and Relatlimab
timeFrame: Up to 4 months
measure: Time-averaged serum concentration at steady state (Cavgss) of Nivolumab and Relatlimab
timeFrame: Up to 4 months
measure: Duration of Response (DOR) by BICR per RECIST v1.1
timeFrame: Up to approximately 3 years
measure: Disease Control Rate (DCR) by BICR per RECIST v1.1
timeFrame: Up to approximately 3 years
measure: Time to Response (TTR), by BICR per RECIST v1.1
timeFrame: Up to approximately 3 years
measure: Objective Response Rate (ORR) by Investigator per RECIST v1.1
timeFrame: Up to approximately 3 years
measure: DOR by Investigator per RECIST v1.1
timeFrame: Up to approximately 3 years
measure: DCR by Investigator per RECIST v1.1
timeFrame: Up to approximately 3 years
measure: TTR by Investigator per RECIST v1.1
timeFrame: Up to approximately 3 years
measure: Progression Free Survival (PFS) by BICR and Investigator per RECIST v1.1
timeFrame: Up to approximately 3 years
measure: Overall Survival
timeFrame: Up to approximately 3 years
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 3 years
measure: Change from Baseline in Functional Assessment of Cancer Therapy - Melanoma Subscale (FACT-MS)
timeFrame: Up to approximately 3 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Local Institution - 0125
state: Arizona
city: Springdale
country: United States
facility: Local Institution - 0189
state: Arkansas
city: Los Angeles
country: United States
facility: Local Institution - 0098
state: California
city: Orange
country: United States
facility: Local Institution - 0093
state: California
city: Stanford
country: United States
facility: Local Institution - 0123
state: California
city: Englewood
country: United States
facility: Local Institution - 0113
state: Colorado
city: Jacksonville
country: United States
facility: Local Institution - 0114
state: Florida
city: Baltimore
country: United States
facility: Local Institution - 0146
state: Maryland
city: Rochester
country: United States
facility: Local Institution - 0071
state: Minnesota
city: Omaha
country: United States
facility: Local Institution - 0013
state: Nebraska
city: Cleveland
country: United States
facility: Local Institution - 0169
state: Ohio
city: Easton
country: United States
facility: Local Institution - 0139
state: Pennsylvania
city: Philadelphia
country: United States
facility: Local Institution - 0124
state: Pennsylvania
city: Murray
country: United States
facility: Local Institution - 0122
state: Utah
city: Fairfax
country: United States
facility: Local Institution - 0115
state: Virginia
city: Coffs Harbour
country: Australia
facility: Local Institution - 0050
state: New South Wales
city: Orange
country: Australia
facility: Local Institution - 0175
state: New South Wales
city: Port Macquarie
country: Australia
facility: Local Institution - 0172
state: New South Wales
city: Wagga Wagga
country: Australia
facility: Local Institution - 0118
state: New South Wales
city: Waratah
country: Australia
facility: Local Institution - 0184
state: New South Wales
city: Westmead
country: Australia
facility: Local Institution - 0033
state: New South Wales
city: Wollstonecraft
country: Australia
facility: Local Institution - 0055
state: New South Wales
city: Birtinya
country: Australia
facility: Local Institution - 0090
state: Queensland
city: Bendigo
country: Australia
facility: Local Institution - 0008
state: Victoria
city: Box Hill
country: Australia
facility: Local Institution - 0059
state: Victoria
city: Heidelberg
country: Australia
facility: Local Institution - 0154
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution - 0030
state: Victoria
city: Traralgon
country: Australia
facility: Local Institution - 0109
state: Victoria
city: Nedlands
country: Australia
facility: Local Institution - 0106
state: Western Australia
city: Nedlands
country: Australia
facility: Local Institution - 0161
state: Western Australia
city: Graz
country: Austria
facility: Local Institution - 0027
city: Salzburg
country: Austria
facility: Local Institution - 0029
city: St. Polten
country: Austria
facility: Local Institution - 0168
city: Wien
country: Austria
facility: Local Institution - 0037
city: Brussels
country: Belgium
facility: Local Institution - 0072
city: Charleroi
country: Belgium
facility: Local Institution - 0078
city: Liege
country: Belgium
facility: Local Institution - 0016
city: Fortaleza
country: Brazil
facility: Local Institution - 0177
state: Ce
city: Vitoria
country: Brazil
facility: Local Institution - 0180
state: ES
city: Belo Horizonte
country: Brazil
facility: Local Institution - 0107
state: Minas Gerais
city: Ijui
country: Brazil
facility: Local Institution - 0025
state: Rio Grande Do Sul
city: Porto Alegrelegre
country: Brazil
facility: Local Institution - 0002
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution - 0031
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution - 0058
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Local Institution - 0009
state: Sao Paulo
city: Sao Jose do Rio Preto
country: Brazil
facility: Local Institution - 0018
state: Sao Paulo
city: Blumenau
country: Brazil
facility: Local Institution - 0159
state: SC
city: Rio De Janeiro
country: Brazil
facility: Local Institution - 0110
city: Sao Paulo
country: Brazil
facility: Local Institution - 0130
city: Calgary
country: Canada
facility: Local Institution - 0141
state: Alberta
city: Hamilton
country: Canada
facility: Local Institution - 0121
state: Ontario
city: Ottawa
country: Canada
facility: Local Institution - 0096
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0116
state: Ontario
city: Quebec
country: Canada
facility: Local Institution - 0103
city: Temuco
country: Chile
facility: Local Institution - 0143
state: Araucania
city: Puerto Montt
country: Chile
facility: Local Institution - 0178
state: Los Lagos
city: Recoleta
country: Chile
facility: Local Institution - 0140
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0144
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0010
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0074
state: Metropolitana
city: Santiago de Chile
country: Chile
facility: Local Institution - 0119
state: Providencia
city: Vina Del Mar
country: Chile
facility: Local Institution - 0028
state: Valparaiso
city: Santiago
country: Chile
facility: Local Institution - 0017
city: Prague
country: Czechia
facility: Local Institution - 0083
state: NY
city: Hradec Kralove
country: Czechia
facility: Local Institution - 0094
city: Olomouc
country: Czechia
facility: Local Institution - 0091
city: Ostrava Poruba
country: Czechia
facility: Local Institution - 0082
city: Prague
country: Czechia
facility: Local Institution - 0095
city: Helsinki
country: Finland
facility: Local Institution - 0164
city: Tampere
country: Finland
facility: Local Institution - 0167
city: Turku
country: Finland
facility: Local Institution - 0162
city: Toulouse
country: France
facility: Local Institution - 0108
state: Cedex 9
city: Paris
country: France
facility: Local Institution - 0034
state: Ile De France
city: Chambray-les-Tours
country: France
facility: Local Institution - 0127
state: Indre-Et-Loire
city: Lille
country: France
facility: Local Institution - 0111
state: Nord
city: Nantes Cedex 01
country: France
facility: Local Institution - 0063
state: OH
city: Villejuif Cedex
country: France
facility: Local Institution - 0061
state: Val-De-Marne
city: Amiens
country: France
facility: Local Institution - 0007
city: Bayonne
country: France
facility: Local Institution - 0128
city: Bordeaux
country: France
facility: Local Institution - 0022
city: Clermont Ferrand Cedex 1
country: France
facility: Local Institution - 0129
city: Dijon
country: France
facility: Local Institution - 0046
city: Marseille
country: France
facility: Local Institution - 0117
city: Pierre-Benite
country: France
facility: Local Institution - 0052
city: Rennes Cedex
country: France
facility: Local Institution - 0089
city: Rouen
country: France
facility: Local Institution - 0099
city: Heidelberg
country: Germany
facility: Local Institution - 0101
state: Baden-Wurttemberg
city: Ulm
country: Germany
facility: Local Institution - 0079
state: Baden-Wurttemberg
city: Regensburg
country: Germany
facility: Local Institution - 0011
state: Bayern
city: Luebeck
country: Germany
facility: Local Institution - 0003
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Local Institution - 0060
city: Buxtehude
country: Germany
facility: Local Institution - 0038
city: Dortmund
country: Germany
facility: Local Institution - 0136
city: Erfurt
country: Germany
facility: Local Institution - 0039
city: Essen
country: Germany
facility: Local Institution - 0049
city: Frankfurt am Main
country: Germany
facility: Local Institution - 0166
city: Giessen
country: Germany
facility: Local Institution - 0065
city: Goettingen
country: Germany
facility: Local Institution - 0135
city: Hamburg
country: Germany
facility: Local Institution - 0138
city: Ludwigshafen
country: Germany
facility: Local Institution - 0137
city: Marburg
country: Germany
facility: Local Institution - 0165
city: Minden
country: Germany
facility: Local Institution - 0044
city: Nuernberg
country: Germany
facility: Local Institution - 0112
city: Rostock
country: Germany
facility: Local Institution - 0053
city: Tuebingen
country: Germany
facility: Local Institution - 0081
city: Afula
country: Israel
facility: Local Institution - 0026
city: Jerusalem
country: Israel
facility: Local Institution - 0054
city: Petah-Tikvah
country: Israel
facility: Local Institution - 0102
city: Tel Hashomer
country: Israel
facility: Local Institution - 0035
city: Tel-Aviv
country: Israel
facility: Local Institution - 0173
city: Bari
country: Italy
facility: Local Institution - 0051
city: Genova
country: Italy
facility: Local Institution - 0077
city: Milan
country: Italy
facility: Local Institution - 0170
city: Napoli
country: Italy
facility: Local Institution - 0084
city: Perugia
country: Italy
facility: Local Institution - 0032
city: Roma
country: Italy
facility: Local Institution - 0064
city: Siena
country: Italy
facility: Local Institution - 0014
city: Bodo
country: Norway
facility: Local Institution - 0163
city: Gralum
country: Norway
facility: Local Institution - 0156
city: Lørenskog
country: Norway
facility: Local Institution - 0158
city: Oslo
country: Norway
facility: Local Institution - 0155
city: Bydgoszcz
country: Poland
facility: Local Institution - 0171
state: Kujawsko-pomorskie
city: Krakow
country: Poland
facility: Local Institution - 0021
state: Malopolskie
city: Opole
country: Poland
facility: Local Institution - 0005
state: Opolskie
city: Poznan
country: Poland
facility: Local Institution - 0015
state: Wiekopolskie
city: Warszawa
country: Poland
facility: Local Institution - 0066
city: Donostia
country: Spain
facility: Local Institution - 0012
state: Gipuzkoa
city: A Coruna
country: Spain
facility: Local Institution - 0086
city: Badalona
country: Spain
facility: Local Institution - 0134
city: Barcelona
country: Spain
facility: Local Institution - 0047
city: Barcelona
country: Spain
facility: Local Institution - 0024
city: Jaen
country: Spain
facility: Local Institution - 0153
city: Las Palmas de Gran Canaria
country: Spain
facility: Local Institution - 0045
city: Madrid
country: Spain
facility: Local Institution - 0040
city: Madrid
country: Spain
facility: Local Institution - 0126
city: Madrid
country: Spain
facility: Local Institution - 0004
city: Madrid
country: Spain
facility: Local Institution - 0056
city: Sevilla
country: Spain
facility: Local Institution - 0006
city: Valencia
country: Spain
facility: Local Institution - 0041
city: Valencia
country: Spain
facility: Local Institution - 0043
city: Valencia
country: Spain
facility: Local Institution - 0151
city: Solna
country: Sweden
facility: Local Institution - 0062
state: Stockholm
city: Lund
country: Sweden
facility: Local Institution - 0097
city: Bern
country: Switzerland
facility: Local Institution - 0092
city: Chur
country: Switzerland
facility: Local Institution - 0080
city: Lausanne
country: Switzerland
facility: Local Institution - 0105
city: London
country: United Kingdom
facility: Local Institution - 0088
state: Greater London
city: Headington, Oxford
country: United Kingdom
facility: Local Institution - 0068
state: Oxfordshire
city: Newcastle Upon Tyne
country: United Kingdom
facility: Local Institution - 0120
state: Tyne And Wear
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: