Clinical trial NCT04099251: Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
Official title: A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-09-23
Enrollment: 790
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 the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric participants after complete resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for recurrence.


Eligibility criteria: Inclusion Criteria:

* Had a negative sentinel lymph node biopsy
* Participant has not been previously treated for melanoma
* ECOG 0 or 1
* Participants must have been diagnosed with histologically confirmed, Resected, Stage IIB/C cutaneous melanoma

Exclusion Criteria:

* History of ocular or mucosal melanoma.
* Pregnant or nursing women
* Participants with active known or suspected autoimmune disease
* Known history of allergy or hypersensitivity to study drug components
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or agents that target IL-2 pathways, T-cell stimulators, or checkpoint pathways

Other protocol defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Recurrence Free Survival (RFS)
timeFrame: From randomization up to the date of first recurrence, new primary melanoma, or death (whatever the cause), whichever occurs first (up to 32 months)
Secondary outcomes:
measure: Distant Metastasis-Free Survival (DMFS)
timeFrame: From randomization up to the date of first distant metastasis or date of death (whatever the cause), whichever occurs first (up to approximately 32 months)
measure: Duration of Treatment on Next Line Therapy Per Investigator Assessment
timeFrame: From first dose date of next-line therapy to last dose date of next-line therapy (up to approximately 32 months)
measure: Progression-Free Survival Through Next-Line Therapy
timeFrame: From randomization to recurrence/objective disease progression after the start of the next-line therapy, or to the start of a second next-line systemic therapy, or to death from any cause, whichever occurs first (up to approximately 32 months)
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
measure: Number of Participants Experiencing Adverse Events Leading to Discontinuation
timeFrame: From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
measure: Number of Participants Experiencing Select Adverse Events
timeFrame: From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
measure: Number of Participants Experiencing Serious Adverse Events (SAEs)
timeFrame: From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
measure: Number of Participants Experiencing Death
timeFrame: From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
measure: Number of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities in Selected Hematology Parameters
timeFrame: From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
measure: Number of Participants Experiencing Laboratory Abnormalities in Selected Liver Parameters
timeFrame: From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
measure: Overall Survival (OS)
timeFrame: From randomization up to the date of death or the last date the participant was known to be alive
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 0088
state: Alabama
city: Tucson
country: United States
facility: Local Institution - 0126
state: Arizona
city: Springdale
country: United States
facility: Local Institution - 0087
state: Arkansas
city: Los Angeles
country: United States
facility: Local Institution - 0080
state: California
city: San Francisco
country: United States
facility: Local Institution - 0077
state: California
city: San Francisco
country: United States
facility: Local Institution - 0119
state: California
city: San Jose
country: United States
facility: Local Institution - 0122
state: California
city: Vallejo
country: United States
facility: Local Institution - 0109
state: California
city: Vallejo
country: United States
facility: Local Institution - 0120
state: California
city: Vallejo
country: United States
facility: Local Institution - 0121
state: California
city: Aurora
country: United States
facility: Local Institution - 0091
state: Colorado
city: Washington
country: United States
facility: Local Institution - 0089
state: District of Columbia
city: Atlanta
country: United States
facility: Local Institution - 0141
state: Georgia
city: Chicago
country: United States
facility: Local Institution - 0132
state: Illinois
city: Baltimore
country: United States
facility: Local Institution - 0135
state: Maryland
city: Boston
country: United States
facility: Local Institution - 0078
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0127
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0143
state: Massachusetts
city: Robbinsdale
country: United States
facility: Local Institution - 0081
state: Minnesota
city: Omaha
country: United States
facility: Local Institution - 0079
state: Nebraska
city: Hackensack
country: United States
facility: Local Institution - 0093
state: New Jersey
city: New York
country: United States
facility: Local Institution - 0094
state: New York
city: Charlotte
country: United States
facility: Local Institution - 0086
state: North Carolina
city: Cleveland
country: United States
facility: Local Institution - 0099
state: Ohio
city: Portland
country: United States
facility: Local Institution - 0076
state: Oregon
city: Allentown
country: United States
facility: Local Institution - 0092
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 0031
state: Pennsylvania
city: Germantown
country: United States
facility: Local Institution - 0148
state: Tennessee
city: Austin
country: United States
facility: Local Institution - 0144
state: Texas
city: Dallas
country: United States
facility: Local Institution - 0085
state: Texas
city: Fairfax
country: United States
facility: Local Institution - 0090
state: Virginia
city: Waratah
country: Australia
facility: Local Institution - 0018
state: New South Wales
city: Westmead
country: Australia
facility: Local Institution - 0025
state: New South Wales
city: Wollstonecraft
country: Australia
facility: Local Institution - 0016
state: New South Wales
city: Cairns
country: Australia
facility: Local Institution - 0105
state: Queensland
city: Greenslopes
country: Australia
facility: Local Institution - 0017
state: Queensland
city: Herston
country: Australia
facility: Local Institution - 0024
state: Queensland
city: Southport
country: Australia
facility: Local Institution - 0138
state: Queensland
city: Box Hill
country: Australia
facility: Local Institution - 0019
state: Victoria
city: Geelong
country: Australia
facility: Local Institution - 0125
state: Victoria
city: Malvern
country: Australia
facility: Local Institution - 0128
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution - 0106
state: Victoria
city: Nedlands
country: Australia
facility: Local Institution - 0104
state: Western Australia
city: Graz
country: Austria
facility: Local Institution - 0049
city: Innsbruck
country: Austria
facility: Local Institution - 0051
city: Salzburg
country: Austria
facility: Local Institution - 0050
city: Wien
country: Austria
facility: Local Institution - 0048
city: Charleroi
country: Belgium
facility: Local Institution - 0028
city: Gent
country: Belgium
facility: Local Institution - 0011
city: Kortrijk
country: Belgium
facility: Local Institution - 0008
city: Liège
country: Belgium
facility: Local Institution - 0010
city: Calgary
country: Canada
facility: Local Institution - 0134
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution - 0133
state: British Columbia
city: Halifax
country: Canada
facility: Local Institution - 0131
state: Nova Scotia
city: Hamilton
country: Canada
facility: Local Institution - 0142
state: Ontario
city: Kingston
country: Canada
facility: Local Institution - 0124
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0140
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 0116
state: Quebec
city: Sherbrooke
country: Canada
facility: Local Institution - 0123
state: Quebec
city: Prague
country: Czechia
facility: Local Institution - 0074
state: Praha 2
city: Ostrava-Poruba
country: Czechia
facility: Local Institution - 0075
city: Praha 10
country: Czechia
facility: Local Institution - 0073
city: Aarhus N
country: Denmark
facility: Local Institution - 0007
city: Herlev
country: Denmark
facility: Local Institution - 0012
city: Odense
country: Denmark
facility: Local Institution - 0013
city: Helsinki
country: Finland
facility: Local Institution - 0014
state: Etelä-Suomen Lääni
city: Tampere
country: Finland
facility: Local Institution - 0015
state: Pirkanmaa
city: Turku
country: Finland
facility: Local Institution - 0110
city: Brest
country: France
facility: Local Institution - 0113
state: Finistère
city: Besancon Cedex
country: France
facility: Local Institution - 0129
city: Bordeaux
country: France
facility: Local Institution - 0112
city: Lille
country: France
facility: Local Institution - 0111
city: Marseille
country: France
facility: Local Institution - 0033
city: Nantes
country: France
facility: Local Institution - 0035
city: Nice
country: France
facility: Local Institution - 0130
city: Paris
country: France
facility: Local Institution - 0036
city: Pierre Benite Cedex
country: France
facility: Local Institution - 0032
city: Villejuif
country: France
facility: Local Institution - 0034
city: München
country: Germany
facility: Local Institution - 0056
state: Bayern
city: Bonn
country: Germany
facility: Local Institution - 0072
city: Buxtehude
country: Germany
facility: Local Institution - 0061
city: Dresden
country: Germany
facility: Local Institution - 0098
city: Essen
country: Germany
facility: Local Institution - 0054
city: Gera
country: Germany
facility: Local Institution - 0062
city: Goettingen
country: Germany
facility: Local Institution - 0114
city: Hannover
country: Germany
facility: Local Institution - 0060
city: Heidelberg
country: Germany
facility: Local Institution - 0055
city: Lubeck
country: Germany
facility: Local Institution - 0057
city: Mainz
country: Germany
facility: Local Institution - 0100
city: Regensburg
country: Germany
facility: Local Institution - 0102
city: Tuebingen
country: Germany
facility: Local Institution - 0058
city: Athina
country: Greece
facility: Local Institution - 0082
city: Piraeus
country: Greece
facility: Local Institution - 0084
city: Thessaloniki
country: Greece
facility: Local Institution - 0083
city: Palermo
country: Italy
facility: A.O.U. Policlinico Paolo Giaccone
state: Sicilia
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII
city: Milano
country: Italy
facility: IRCCS Istituto Nazionale Tumori Milano
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia IRCCS
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione Pascale
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IOV
city: Perugia
country: Italy
facility: Azienda Ospedaliera Di Perugia
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
city: Breda
country: Netherlands
facility: Local Institution - 0107
city: Groningen
country: Netherlands
facility: Local Institution - 0001
city: Rotterdam
country: Netherlands
facility: Local Institution - 0030
city: Utrecht
country: Netherlands
facility: Local Institution - 0002
city: Bergen
country: Norway
facility: Local Institution - 0063
city: Gralum
country: Norway
facility: Local Institution - 0027
city: Oslo
country: Norway
facility: Local Institution - 0005
city: Poznan
country: Poland
facility: Local Institution - 0103
state: Wielkopolskie
city: Gdansk
country: Poland
facility: Local Institution - 0023
city: Warszawa
country: Poland
facility: Local Institution - 0022
city: Cluj-Napoca
country: Romania
facility: Local Institution - 0047
city: Craiova
country: Romania
facility: Local Institution - 0020
city: Sector 2
country: Romania
facility: Local Institution - 0021
city: A Coruña
country: Spain
facility: Local Institution - 0067
city: Badalona
country: Spain
facility: Local Institution - 0065
city: Barcelona
country: Spain
facility: Local Institution - 0071
city: Madrid
country: Spain
facility: Local Institution - 0066
city: Madrid
country: Spain
facility: Local Institution - 0070
city: Malaga
country: Spain
facility: Local Institution - 0068
city: Santander
country: Spain
facility: Local Institution - 0064
city: Valencia
country: Spain
facility: Local Institution - 0069
city: Orebro
country: Sweden
facility: Local Institution - 0026
city: Linköping
country: Sweden
facility: Local Institution - 0003
state: Östergötlands Län [se-05]
city: Lausanne
country: Switzerland
facility: Local Institution - 0053
city: Zuerich
country: Switzerland
facility: Local Institution - 0052
city: Cardiff
country: United Kingdom
facility: Local Institution - 0044
city: Southampton
country: United Kingdom
facility: Local Institution - 0095
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: