Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma (CheckMate 238)
Primary Purpose
Melanoma
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ipilimumab
Nivolumab
Placebo matching Ipilimumab
Placebo matching Nivolumab
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma
Eligibility Criteria
Inclusion Criteria:
- At least 15 years of age Except: where local regulations and/or institutional policies do not allow for subjects < 18 years of age (pediatric population) to participate. For those sites, the eligible subject population is ≥ 18 years of age
- Completely removed melanoma by surgery performed within 12 weeks of randomization
- Stage IIIb/C or Stage IV before complete resection
- No previous anti-cancer treatment
Exclusion Criteria:
- Ocular or uveal melanoma
- History of carcinomatosis meningitis
- History of auto-immune disease
- Treatment directed against the resected melanoma that is administrated after the surgery
Other protocol-defined inclusion/exclusion criteria apply
Sites / Locations
- Local Institution - 0036
- Local Institution - 0117
- Local Institution - 0189
- Local Institution - 0021
- Local Institution - 0006
- Local Institution - 0010
- Local Institution - 0004
- Local Institution - 0012
- Local Institution - 0019
- Local Institution - 0030
- Local Institution - 0032
- Local Institution - 0016
- Local Institution - 0106
- Local Institution - 0013
- Local Institution - 0170
- Local Institution - 0171
- Local Institution - 0015
- Local Institution - 0002
- Local Institution - 0017
- Local Institution - 0123
- Local Institution - 0095
- Local Institution - 0024
- Local Institution - 0033
- Local Institution - 0003
- Local Institution - 0025
- Local Institution - 0157
- Local Institution - 0031
- Local Institution - 0029
- Local Institution - 0022
- Local Institution - 0001
- Local Institution - 0026
- Local Institution - 0014
- Local Institution - 0005
- Local Institution - 0027
- Local Institution - 0126
- Local Institution - 0142
- Local Institution - 0140
- Local Institution
- Local Institution - 0079
- Local Institution - 0080
- Local Institution - 0078
- Local Institution - 0082
- Local Institution - 0083
- Local Institution - 0084
- Local Institution - 0075
- Local Institution - 0077
- Local Institution - 0085
- Local Institution - 0081
- Local Institution - 0169
- Local Institution - 0168
- Local Institution - 0038
- Local Institution - 0040
- Local Institution - 0037
- Local Institution - 0039
- Local Institution - 0051
- Local Institution - 0074
- Local Institution - 0094
- Local Institution - 0105
- Local Institution - 0046
- Local Institution - 0101
- Local Institution - 0102
- Local Institution - 0099
- Local Institution - 0100
- Local Institution - 0047
- Local Institution - 0048
- Local Institution - 0138
- Local Institution - 0135
- Local Institution - 0134
- Local Institution - 0136
- Local Institution - 0133
- Local Institution - 0137
- Local Institution - 0086
- Local Institution - 0087
- Local Institution - 0163
- Local Institution - 0166
- Local Institution - 0063
- Local Institution - 0108
- Local Institution - 0064
- Local Institution - 0112
- Local Institution - 0116
- Local Institution - 0115
- Local Institution - 0113
- Local Institution - 0107
- Local Institution - 0111
- Local Institution - 0114
- Local Institution - 0110
- Local Institution - 0179
- Local Institution - 0161
- Local Institution - 0174
- Local Institution - 0162
- Local Institution - 0160
- Local Institution - 0175
- Local Institution - 0176
- Local Institution - 0159
- Local Institution - 0158
- Local Institution - 0180
- Local Institution - 0129
- Local Institution - 0127
- Local Institution - 0144
- Local Institution - 0128
- Local Institution - 0042
- Local Institution - 0045
- Local Institution - 0043
- Local Institution - 0041
- Local Institution - 0098
- Local Institution - 0109
- Local Institution - 0150
- Local Institution - 0149
- Local Institution - 0152
- Local Institution - 0156
- Local Institution - 0153
- Local Institution - 0148
- Local Institution - 0145
- Local Institution - 0147
- Local Institution - 0181
- Local Institution - 0146
- Local Institution - 0120
- Local Institution - 0119
- Local Institution - 0121
- Local Institution - 0122
- Local Institution - 0050
- Local Institution - 0096
- Local Institution - 0167
- Local Institution - 0131
- Local Institution - 0132
- Local Institution - 0130
- Local Institution - 0057
- Local Institution - 0052
- Local Institution - 0165
- Local Institution - 0054
- Local Institution - 0056
- Local Institution - 0177
- Local Institution - 0055
- Local Institution - 0060
- Local Institution - 0097
- Local Institution - 0053
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Ipilimumab and Placebo matching Nivolumab
Nivolumab and Placebo matching Ipilimumab
Arm Description
Outcomes
Primary Outcome Measures
Recurrence-free Survival (RFS)
RFS is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma, or death (whatever the cause), whichever occurs first.
Secondary Outcome Measures
Overall Survival (OS)
OS is defined as as the time between the date of randomization and the date of death.
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Adverse Events
the safety and tolerability of Nivolumab and Ipilimumab was measured by the incidence of adverse events
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Serious Adverse Events
The Safety and Tolerability of nivolumab and ipilimumab was measured by the incidence of serious adverse events
the Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Deaths
the safety and tolerability of Nivolumab and Ipilimumab wasmeasured by the incidence of Deaths
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
The Safety and Tolerability of Nivolumab and Ipilimumab measured by the incidence of Laboratory abnormalities.
Recurrence-free Survival by PD-L1 Expression
Recurrence-free survival by PD-L1 Expression(5% tumor cell membrane expression)
Health Related Quality of Life (HRQoL) Evaluation
HRQoL was measured by mean changes from baseline in EORTC-QLQ-C30 global health status/QoL composite scale and in remaining EORTC QLQ-C30 scales in all randomized participants.
EORTC QLQ-C30 is the most commonly used QoL instrument in melanoma clinical studies, is a 30-item instrument that has gained wide acceptance in oncology clinical studies and comprises 5 functional scales (physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Except for the overall health status and global quality of life items, responses for all items are 4 point categorical scales ranging from 1 (Not at all) to 4 (Very much). The overall health status/quality of life responses are 7-point Likert scales for which higher score reflects higher health status/quality of life for the 7-point Likert scale.
Full Information
NCT ID
NCT02388906
First Posted
March 10, 2015
Last Updated
October 19, 2023
Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02388906
Brief Title
Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma
Acronym
CheckMate 238
Official Title
A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab Versus Ipilimumab After Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects Who Are at High Risk for Recurrence (CheckMate 238: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 238)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 19, 2015 (Actual)
Primary Completion Date
November 26, 2018 (Actual)
Study Completion Date
October 6, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
906 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ipilimumab and Placebo matching Nivolumab
Arm Type
Experimental
Arm Title
Nivolumab and Placebo matching Ipilimumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Intervention Description
Specified dose on specified days
Intervention Type
Other
Intervention Name(s)
Placebo matching Ipilimumab
Intervention Description
Specified dose on specified days
Intervention Type
Other
Intervention Name(s)
Placebo matching Nivolumab
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Recurrence-free Survival (RFS)
Description
RFS is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma, or death (whatever the cause), whichever occurs first.
Time Frame
up to 36 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as as the time between the date of randomization and the date of death.
Time Frame
up to 60 months
Title
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Adverse Events
Description
the safety and tolerability of Nivolumab and Ipilimumab was measured by the incidence of adverse events
Time Frame
reported between first dose and 30 days after last dose of study therapy
Title
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Serious Adverse Events
Description
The Safety and Tolerability of nivolumab and ipilimumab was measured by the incidence of serious adverse events
Time Frame
reported between the first dose and 30 days after last dose of study therapy
Title
the Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Deaths
Description
the safety and tolerability of Nivolumab and Ipilimumab wasmeasured by the incidence of Deaths
Time Frame
reported between first dose and 30 to 100 days after last dose of study therapy
Title
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Description
The Safety and Tolerability of Nivolumab and Ipilimumab measured by the incidence of Laboratory abnormalities.
Time Frame
reported after first dose and within 30 days of last dose of the study therapy
Title
Recurrence-free Survival by PD-L1 Expression
Description
Recurrence-free survival by PD-L1 Expression(5% tumor cell membrane expression)
Time Frame
up to 36 months
Title
Health Related Quality of Life (HRQoL) Evaluation
Description
HRQoL was measured by mean changes from baseline in EORTC-QLQ-C30 global health status/QoL composite scale and in remaining EORTC QLQ-C30 scales in all randomized participants.
EORTC QLQ-C30 is the most commonly used QoL instrument in melanoma clinical studies, is a 30-item instrument that has gained wide acceptance in oncology clinical studies and comprises 5 functional scales (physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Except for the overall health status and global quality of life items, responses for all items are 4 point categorical scales ranging from 1 (Not at all) to 4 (Very much). The overall health status/quality of life responses are 7-point Likert scales for which higher score reflects higher health status/quality of life for the 7-point Likert scale.
Time Frame
up to 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 15 years of age Except: where local regulations and/or institutional policies do not allow for subjects < 18 years of age (pediatric population) to participate. For those sites, the eligible subject population is ≥ 18 years of age
Completely removed melanoma by surgery performed within 12 weeks of randomization
Stage IIIb/C or Stage IV before complete resection
No previous anti-cancer treatment
Exclusion Criteria:
Ocular or uveal melanoma
History of carcinomatosis meningitis
History of auto-immune disease
Treatment directed against the resected melanoma that is administrated after the surgery
Other protocol-defined inclusion/exclusion criteria apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0036
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Local Institution - 0117
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0698
Country
United States
Facility Name
Local Institution - 0189
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Local Institution - 0021
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Local Institution - 0006
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Local Institution - 0010
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Local Institution - 0004
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Local Institution - 0012
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Local Institution - 0019
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Local Institution - 0030
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Local Institution - 0032
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Local Institution - 0016
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Local Institution - 0106
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Local Institution - 0013
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 0170
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 0171
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 0015
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5869
Country
United States
Facility Name
Local Institution - 0002
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Local Institution - 0017
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Local Institution - 0123
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Local Institution - 0095
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Local Institution - 0024
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Local Institution - 0033
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Local Institution - 0003
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Local Institution - 0025
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Local Institution - 0157
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Local Institution - 0031
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Local Institution - 0029
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Local Institution - 0022
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Local Institution - 0001
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Local Institution - 0026
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Local Institution - 0014
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-1624
Country
United States
Facility Name
Local Institution - 0005
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Local Institution - 0027
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Local Institution - 0126
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Local Institution - 0142
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Local Institution - 0140
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Local Institution
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Local Institution - 0079
City
Gateshead
State/Province
New South Wales
ZIP/Postal Code
2290
Country
Australia
Facility Name
Local Institution - 0080
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Local Institution - 0078
City
Wollstonecraft
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Local Institution - 0082
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Local Institution - 0083
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Local Institution - 0084
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Local Institution - 0075
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Local Institution - 0077
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Local Institution - 0085
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Local Institution - 0081
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Facility Name
Local Institution - 0169
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Local Institution - 0168
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Local Institution - 0038
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Local Institution - 0040
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Local Institution - 0037
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Local Institution - 0039
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Local Institution - 0051
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Local Institution - 0074
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Local Institution - 0094
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Local Institution - 0105
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Local Institution - 0046
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Local Institution - 0101
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Local Institution - 0102
City
Ostrava-Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Local Institution - 0099
City
Praha 1
ZIP/Postal Code
110 00
Country
Czechia
Facility Name
Local Institution - 0100
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Local Institution - 0047
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Local Institution - 0048
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Facility Name
Local Institution - 0138
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Local Institution - 0135
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Local Institution - 0134
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Local Institution - 0136
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Local Institution - 0133
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Local Institution - 0137
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution - 0086
City
Athens
ZIP/Postal Code
11526
Country
Greece
Facility Name
Local Institution - 0087
City
Neo Faliro
ZIP/Postal Code
18547
Country
Greece
Facility Name
Local Institution - 0163
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Local Institution - 0166
City
Dublin 7
ZIP/Postal Code
0
Country
Ireland
Facility Name
Local Institution - 0063
City
Dublin
ZIP/Postal Code
01
Country
Ireland
Facility Name
Local Institution - 0108
City
Dublin
ZIP/Postal Code
4
Country
Ireland
Facility Name
Local Institution - 0064
City
Galway
Country
Ireland
Facility Name
Local Institution - 0112
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Local Institution - 0116
City
Genova
ZIP/Postal Code
16128
Country
Italy
Facility Name
Local Institution - 0115
City
Meldola (FC)
ZIP/Postal Code
47014
Country
Italy
Facility Name
Local Institution - 0113
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Local Institution - 0107
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution - 0111
City
Padova
ZIP/Postal Code
Padova
Country
Italy
Facility Name
Local Institution - 0114
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Local Institution - 0110
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Local Institution - 0179
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Local Institution - 0161
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
8128582
Country
Japan
Facility Name
Local Institution - 0174
City
Tsukuba-shi
State/Province
Ibaraki
ZIP/Postal Code
3058576
Country
Japan
Facility Name
Local Institution - 0162
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
8608556
Country
Japan
Facility Name
Local Institution - 0160
City
Matsumoto-shi
State/Province
Nagano
ZIP/Postal Code
3908621
Country
Japan
Facility Name
Local Institution - 0175
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
9518566
Country
Japan
Facility Name
Local Institution - 0176
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
5400006
Country
Japan
Facility Name
Local Institution - 0159
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
4118777
Country
Japan
Facility Name
Local Institution - 0158
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
1040045
Country
Japan
Facility Name
Local Institution - 0180
City
Chuo-shi
State/Province
Yamanashi
ZIP/Postal Code
4093898
Country
Japan
Facility Name
Local Institution - 0129
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Local Institution - 0127
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Local Institution - 0144
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Local Institution - 0128
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Local Institution - 0042
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Local Institution - 0045
City
Groningen
ZIP/Postal Code
9714 CZ
Country
Netherlands
Facility Name
Local Institution - 0043
City
Nijmegen
ZIP/Postal Code
6525GA
Country
Netherlands
Facility Name
Local Institution - 0041
City
Veldhoven
ZIP/Postal Code
5504 DB
Country
Netherlands
Facility Name
Local Institution - 0098
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Local Institution - 0109
City
Oslo
ZIP/Postal Code
3100
Country
Norway
Facility Name
Local Institution - 0150
City
Gdansk
ZIP/Postal Code
80-219
Country
Poland
Facility Name
Local Institution - 0149
City
Krakow
ZIP/Postal Code
31-115
Country
Poland
Facility Name
Local Institution - 0152
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Local Institution - 0156
City
Craiova
ZIP/Postal Code
200542
Country
Romania
Facility Name
Local Institution - 0153
City
Romania
ZIP/Postal Code
400015
Country
Romania
Facility Name
Local Institution - 0148
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2196
Country
South Africa
Facility Name
Local Institution - 0145
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0075
Country
South Africa
Facility Name
Local Institution - 0147
City
Saxonwold, Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2196
Country
South Africa
Facility Name
Local Institution - 0181
City
Cape Town
State/Province
Western CAPE
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Local Institution - 0146
City
Kraaifontein
State/Province
Western Cape
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Local Institution - 0120
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution - 0119
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Local Institution - 0121
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Local Institution - 0122
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Local Institution - 0050
City
Gothenberg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Local Institution - 0096
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Local Institution - 0167
City
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Local Institution - 0131
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Local Institution - 0132
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
Local Institution - 0130
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Local Institution - 0057
City
Bristol
State/Province
Avon
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Local Institution - 0052
City
Swansea
State/Province
Carmarthenshire
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
Facility Name
Local Institution - 0165
City
London
State/Province
Greater London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Local Institution - 0054
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Local Institution - 0056
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Local Institution - 0177
City
Northwood
State/Province
Middlesex
ZIP/Postal Code
HA6 2JR
Country
United Kingdom
Facility Name
Local Institution - 0055
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Local Institution - 0060
City
Newcastle Upon Tyne
State/Province
Tyne And Wear
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Local Institution - 0097
City
Leicester
ZIP/Postal Code
LE15WW
Country
United Kingdom
Facility Name
Local Institution - 0053
City
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
35964471
Citation
Larkin J, Weber J, Del Vecchio M, Gogas H, Arance AM, Dalle S, Cowey CL, Schenker M, Grob JJ, Chiarion-Sileni V, Marquez-Rodas I, Butler MO, Di Giacomo AM, Middleton MR, De la Cruz-Merino L, Arenberger P, Atkinson V, Hill A, Fecher LA, Millward M, Khushalani NI, Queirolo P, Long GV, Lobo M, Askelson M, Ascierto PA, Mandala M. Adjuvant nivolumab versus ipilimumab (CheckMate 238 trial): Reassessment of 4-year efficacy outcomes in patients with stage III melanoma per AJCC-8 staging criteria. Eur J Cancer. 2022 Sep;173:285-296. doi: 10.1016/j.ejca.2022.06.041. Epub 2022 Aug 11.
Results Reference
derived
PubMed Identifier
34663559
Citation
Weber JS, Ascierto PA, Middleton MR, Hennicken D, Zoffoli R, Pieters A, Amadi A, Kupas K, Kotapati S, Moshyk A, Schadendorf D. Indirect treatment comparison of nivolumab versus placebo as adjuvant treatment for resected melanoma. Eur J Cancer. 2021 Nov;158:225-233. doi: 10.1016/j.ejca.2021.08.028. Epub 2021 Oct 15.
Results Reference
derived
PubMed Identifier
34452930
Citation
Mandala M, Larkin J, Ascierto PA, Del Vecchio M, Gogas H, Cowey CL, Arance A, Dalle S, Schenker M, Grob JJ, Chiarion-Sileni V, Marquez-Rodas I, Butler MO, Di Giacomo AM, Lutzky J, De La Cruz-Merino L, Atkinson V, Arenberger P, Hill A, Fecher L, Millward M, Khushalani NI, de Pril V, Lobo M, Weber J. Adjuvant nivolumab for stage III/IV melanoma: evaluation of safety outcomes and association with recurrence-free survival. J Immunother Cancer. 2021 Aug;9(8):e003188. doi: 10.1136/jitc-2021-003188. Erratum In: J Immunother Cancer. 2021 Nov;9(11):
Results Reference
derived
PubMed Identifier
32961119
Citation
Ascierto PA, Del Vecchio M, Mandala M, Gogas H, Arance AM, Dalle S, Cowey CL, Schenker M, Grob JJ, Chiarion-Sileni V, Marquez-Rodas I, Butler MO, Maio M, Middleton MR, de la Cruz-Merino L, Arenberger P, Atkinson V, Hill A, Fecher LA, Millward M, Khushalani NI, Queirolo P, Lobo M, de Pril V, Loffredo J, Larkin J, Weber J. Adjuvant nivolumab versus ipilimumab in resected stage IIIB-C and stage IV melanoma (CheckMate 238): 4-year results from a multicentre, double-blind, randomised, controlled, phase 3 trial. Lancet Oncol. 2020 Nov;21(11):1465-1477. doi: 10.1016/S1470-2045(20)30494-0. Epub 2020 Sep 19. Erratum In: Lancet Oncol. 2021 Oct;22(10):e428.
Results Reference
derived
PubMed Identifier
28891423
Citation
Weber J, Mandala M, Del Vecchio M, Gogas HJ, Arance AM, Cowey CL, Dalle S, Schenker M, Chiarion-Sileni V, Marquez-Rodas I, Grob JJ, Butler MO, Middleton MR, Maio M, Atkinson V, Queirolo P, Gonzalez R, Kudchadkar RR, Smylie M, Meyer N, Mortier L, Atkins MB, Long GV, Bhatia S, Lebbe C, Rutkowski P, Yokota K, Yamazaki N, Kim TM, de Pril V, Sabater J, Qureshi A, Larkin J, Ascierto PA; CheckMate 238 Collaborators. Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma. N Engl J Med. 2017 Nov 9;377(19):1824-1835. doi: 10.1056/NEJMoa1709030. Epub 2017 Sep 10.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma
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