Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma
- Conditions
- Melanoma
- Interventions
- Registration Number
- NCT02388906
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 906
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ipilimumab and Placebo matching Nivolumab Ipilimumab - Ipilimumab and Placebo matching Nivolumab Placebo matching Nivolumab - Nivolumab and Placebo matching Ipilimumab Nivolumab - Nivolumab and Placebo matching Ipilimumab Placebo matching Ipilimumab -
- Primary Outcome Measures
Name Time Method Recurrence-free Survival (RFS) up to 36 months 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
Name Time Method Overall Survival (OS) up to 106.6 months 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 reported between first dose and 30 days after last dose of study therapy 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 reported between the first dose and 30 days after last dose of study therapy 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 reported between first dose and 30 to 100 days after last dose of study therapy the safety and tolerability of Nivolumab and Ipilimumab was measured by the incidence of Deaths
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities reported after first dose and within 30 days of last dose of the study therapy The Safety and Tolerability of Nivolumab and Ipilimumab measured by the incidence of Laboratory abnormalities.
Recurrence-free Survival by PD-L1 Expression up to 106.6 months Recurrence-free survival by PD-L1 Expression(5% tumor cell membrane expression)
Health Related Quality of Life (HRQoL) Evaluation up to 36 months 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.
Trial Locations
- Locations (136)
Local Institution - 0036
🇺🇸Little Rock, Arkansas, United States
Local Institution - 0117
🇺🇸La Jolla, California, United States
Local Institution - 0010
🇺🇸Aurora, Colorado, United States
Local Institution - 0126
🇺🇸Seattle, Washington, United States
Local Institution - 0082
🇦🇺Greenslopes, Queensland, Australia
Local Institution - 0083
🇦🇺Southport, Queensland, Australia
Local Institution - 0084
🇦🇺Adelaide, South Australia, Australia
Local Institution - 0075
🇦🇺Heidelberg, Victoria, Australia
Local Institution - 0077
🇦🇺Prahran, Victoria, Australia
Local Institution - 0048
🇫🇮Tampere, Finland
Local Institution - 0138
🇫🇷Lille, France
Local Institution - 0135
🇫🇷Marseille Cedex 5, France
Local Institution - 0134
🇫🇷Nantes, France
Local Institution - 0136
🇫🇷Paris, France
Local Institution - 0133
🇫🇷Pierre Benite, France
Local Institution - 0137
🇫🇷Toulouse, France
Local Institution - 0086
🇬🇷Athens, Greece
Local Institution - 0087
🇬🇷Neo Faliro, Greece
Local Institution - 0163
🇭🇺Budapest, Hungary
Local Institution - 0166
🇮🇪Dublin 7, Ireland
Local Institution - 0063
🇮🇪Dublin, Ireland
Local Institution - 0108
🇮🇪Dublin, Ireland
Local Institution - 0064
🇮🇪Galway, Ireland
Local Institution - 0112
🇮🇹Bergamo, Italy
Local Institution - 0116
🇮🇹Genova, Italy
Local Institution - 0115
🇮🇹Meldola (FC), Italy
Local Institution - 0113
🇮🇹Milano, Italy
Local Institution - 0107
🇮🇹Napoli, Italy
Local Institution - 0111
🇮🇹Padova, Italy
Local Institution - 0114
🇮🇹Roma, Italy
Local Institution - 0110
🇮🇹Siena, Italy
Local Institution - 0179
🇯🇵Nagoya, Aichi, Japan
Local Institution - 0161
🇯🇵Fukuoka-shi, Fukuoka, Japan
Local Institution - 0174
🇯🇵Tsukuba-shi, Ibaraki, Japan
Local Institution - 0162
🇯🇵Kumamoto-shi, Kumamoto, Japan
Local Institution - 0160
🇯🇵Matsumoto, Nagano, Japan
Local Institution - 0175
🇯🇵Niigata-shi, Niigata, Japan
Local Institution - 0176
🇯🇵Osaka-shi, Osaka, Japan
Local Institution - 0159
🇯🇵Sunto-gun, Shizuoka, Japan
Local Institution - 0158
🇯🇵Chuo-ku, Tokyo, Japan
Local Institution - 0180
🇯🇵Chuo-shi, Yamanashi, Japan
Local Institution - 0144
🇰🇷Songpa-gu, Seoul, Korea, Republic of
Local Institution - 0129
🇰🇷Seoul, Korea, Republic of
Local Institution - 0127
🇰🇷Seoul, Korea, Republic of
Local Institution - 0128
🇰🇷Seoul, Korea, Republic of
Local Institution - 0042
🇳🇱Amsterdam, Netherlands
Local Institution - 0045
🇳🇱Groningen, Netherlands
Local Institution - 0043
🇳🇱Nijmegen, Netherlands
Local Institution - 0041
🇳🇱Veldhoven, Netherlands
Local Institution - 0098
🇳🇴Bergen, Norway
Local Institution - 0109
🇳🇴Oslo, Norway
Local Institution - 0150
🇵🇱Gdansk, Poland
Local Institution - 0149
🇵🇱Krakow, Poland
Local Institution - 0152
🇵🇱Warszawa, Poland
Local Institution - 0156
🇷🇴Craiova, Romania
Local Institution - 0153
🇷🇴Romania, Romania
Local Institution - 0148
🇿🇦Johannesburg, Gauteng, South Africa
Local Institution - 0145
🇿🇦Pretoria, Gauteng, South Africa
Local Institution - 0147
🇿🇦Saxonwold, Johannesburg, Gauteng, South Africa
Local Institution - 0181
🇿🇦Cape Town, Western CAPE, South Africa
Local Institution - 0119
🇪🇸Madrid, Spain
Local Institution - 0121
🇪🇸Sevilla, Spain
Local Institution - 0122
🇪🇸Valencia, Spain
Local Institution - 0050
🇸🇪Gothenberg, Sweden
Local Institution - 0096
🇸🇪Lund, Sweden
Local Institution - 0167
🇨🇭Zuerich, Switzerland
Local Institution - 0131
🇨🇳Kaohsiung, Taiwan
Local Institution - 0132
🇨🇳Taichung, Taiwan
Local Institution - 0130
🇨🇳Taoyuan, Taiwan
Local Institution - 0057
🇬🇧Bristol, Avon, United Kingdom
Local Institution - 0005
🇺🇸Dallas, Texas, United States
Local Institution - 0027
🇺🇸Charlottesville, Virginia, United States
Local Institution - 0142
🇦🇷Capital Federal, Buenos Aires, Argentina
Local Institution - 0140
🇦🇷San Miguel de Tucuman, Tucuman, Argentina
Local Institution
🇦🇷Cordoba, Argentina
Local Institution - 0079
🇦🇺Gateshead, New South Wales, Australia
Local Institution - 0080
🇦🇺Westmead, New South Wales, Australia
Local Institution - 0078
🇦🇺Wollstonecraft, New South Wales, Australia
Local Institution - 0085
🇦🇺Nedlands, Western Australia, Australia
Local Institution - 0081
🇦🇺Camperdown, Australia
Local Institution - 0169
🇦🇹Graz, Austria
Local Institution - 0168
🇦🇹Salzburg, Austria
Local Institution - 0038
🇧🇪Brussels, Belgium
Local Institution - 0040
🇧🇪Bruxelles, Belgium
Local Institution - 0037
🇧🇪Gent, Belgium
Local Institution - 0039
🇧🇪Leuven, Belgium
Local Institution - 0051
🇨🇦Edmonton, Alberta, Canada
Local Institution - 0189
🇺🇸Los Angeles, California, United States
Local Institution - 0021
🇺🇸San Francisco, California, United States
Local Institution - 0006
🇺🇸San Francisco, California, United States
Local Institution - 0004
🇺🇸Washington, District of Columbia, United States
Local Institution - 0012
🇺🇸Jacksonville, Florida, United States
Local Institution - 0019
🇺🇸Miami Beach, Florida, United States
Local Institution - 0030
🇺🇸Orlando, Florida, United States
Local Institution - 0032
🇺🇸Tampa, Florida, United States
Local Institution - 0016
🇺🇸Atlanta, Georgia, United States
Local Institution - 0106
🇺🇸Chicago, Illinois, United States
Local Institution - 0013
🇺🇸Boston, Massachusetts, United States
Local Institution - 0170
🇺🇸Boston, Massachusetts, United States
Local Institution - 0171
🇺🇸Boston, Massachusetts, United States
Local Institution - 0015
🇺🇸Ann Arbor, Michigan, United States
Local Institution - 0002
🇺🇸Robbinsdale, Minnesota, United States
Local Institution - 0017
🇺🇸Saint Louis, Missouri, United States
Local Institution - 0123
🇺🇸Hackensack, New Jersey, United States
Local Institution - 0095
🇺🇸New Brunswick, New Jersey, United States
Local Institution - 0024
🇺🇸New York, New York, United States
Local Institution - 0033
🇺🇸New York, New York, United States
Local Institution - 0003
🇺🇸Charlotte, North Carolina, United States
Local Institution - 0025
🇺🇸Durham, North Carolina, United States
Local Institution - 0157
🇺🇸Columbus, Ohio, United States
Local Institution - 0031
🇺🇸Portland, Oregon, United States
Local Institution - 0029
🇺🇸Portland, Oregon, United States
Local Institution - 0022
🇺🇸Allentown, Pennsylvania, United States
Local Institution - 0001
🇺🇸Bethlehem, Pennsylvania, United States
Local Institution - 0026
🇺🇸Charleston, South Carolina, United States
Local Institution - 0014
🇺🇸Nashville, Tennessee, United States
Local Institution - 0074
🇨🇦Vancouver, British Columbia, Canada
Local Institution - 0094
🇨🇦Toronto, Ontario, Canada
Local Institution - 0105
🇨🇦Montreal, Quebec, Canada
Local Institution - 0046
🇨🇦Quebec City, Quebec, Canada
Local Institution - 0101
🇨🇿Hradec Kralove, Czechia
Local Institution - 0102
🇨🇿Ostrava-Poruba, Czechia
Local Institution - 0099
🇨🇿Praha 1, Czechia
Local Institution - 0100
🇨🇿Praha 2, Czechia
Local Institution - 0047
🇫🇮Helsinki, Finland
Local Institution - 0146
🇿🇦Kraaifontein, Western Cape, South Africa
Local Institution - 0120
🇪🇸Barcelona, Spain
Local Institution - 0052
🇬🇧Swansea, Carmarthenshire, United Kingdom
Local Institution - 0165
🇬🇧London, Greater London, United Kingdom
Local Institution - 0054
🇬🇧Manchester, Greater Manchester, United Kingdom
Local Institution - 0056
🇬🇧Southampton, Hampshire, United Kingdom
Local Institution - 0177
🇬🇧Northwood, Middlesex, United Kingdom
Local Institution - 0055
🇬🇧Oxford, Oxfordshire, United Kingdom
Local Institution - 0060
🇬🇧Newcastle Upon Tyne, Tyne And Wear, United Kingdom
Local Institution - 0097
🇬🇧Leicester, United Kingdom
Local Institution - 0053
🇬🇧Surrey, United Kingdom