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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02388906
Other study ID # CA209-238
Secondary ID 2014-002351-26
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date March 19, 2015
Est. completion date October 6, 2024

Study information

Verified date January 2024
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 906
Est. completion date October 6, 2024
Est. primary completion date November 26, 2018
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ipilimumab
Specified dose on specified days
Nivolumab
Specified dose on specified days
Other:
Placebo matching Ipilimumab
Specified dose on specified days
Placebo matching Nivolumab
Specified dose on specified days

Locations

Country Name City State
Argentina Local Institution - 0142 Capital Federal Buenos Aires
Argentina Local Institution Cordoba
Argentina Local Institution - 0140 San Miguel de Tucuman Tucuman
Australia Local Institution - 0084 Adelaide South Australia
Australia Local Institution - 0081 Camperdown
Australia Local Institution - 0079 Gateshead New South Wales
Australia Local Institution - 0082 Greenslopes Queensland
Australia Local Institution - 0075 Heidelberg Victoria
Australia Local Institution - 0085 Nedlands Western Australia
Australia Local Institution - 0077 Prahran Victoria
Australia Local Institution - 0083 Southport Queensland
Australia Local Institution - 0080 Westmead New South Wales
Australia Local Institution - 0078 Wollstonecraft New South Wales
Austria Local Institution - 0169 Graz
Austria Local Institution - 0168 Salzburg
Belgium Local Institution - 0038 Brussels
Belgium Local Institution - 0040 Bruxelles
Belgium Local Institution - 0037 Gent
Belgium Local Institution - 0039 Leuven
Canada Local Institution - 0051 Edmonton Alberta
Canada Local Institution - 0105 Montreal Quebec
Canada Local Institution - 0046 Quebec City Quebec
Canada Local Institution - 0094 Toronto Ontario
Canada Local Institution - 0074 Vancouver British Columbia
Czechia Local Institution - 0101 Hradec Kralove
Czechia Local Institution - 0102 Ostrava-Poruba
Czechia Local Institution - 0099 Praha 1
Czechia Local Institution - 0100 Praha 2
Finland Local Institution - 0047 Helsinki
Finland Local Institution - 0048 Tampere
France 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
Greece Local Institution - 0086 Athens
Greece Local Institution - 0087 Neo Faliro
Hungary Local Institution - 0163 Budapest
Ireland Local Institution - 0063 Dublin
Ireland Local Institution - 0108 Dublin
Ireland Local Institution - 0166 Dublin 7
Ireland Local Institution - 0064 Galway
Italy 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
Japan Local Institution - 0158 Chuo-ku Tokyo
Japan Local Institution - 0180 Chuo-shi Yamanashi
Japan Local Institution - 0161 Fukuoka-shi Fukuoka
Japan Local Institution - 0162 Kumamoto-shi Kumamoto
Japan Local Institution - 0160 Matsumoto Nagano
Japan Local Institution - 0179 Nagoya Aichi
Japan Local Institution - 0175 Niigata-shi Niigata
Japan Local Institution - 0176 Osaka-shi Osaka
Japan Local Institution - 0159 Sunto-gun Shizuoka
Japan Local Institution - 0174 Tsukuba-shi Ibaraki
Korea, Republic of Local Institution - 0127 Seoul
Korea, Republic of Local Institution - 0128 Seoul
Korea, Republic of Local Institution - 0129 Seoul
Korea, Republic of Local Institution - 0144 Songpa-gu Seoul
Netherlands Local Institution - 0042 Amsterdam
Netherlands Local Institution - 0045 Groningen
Netherlands Local Institution - 0043 Nijmegen
Netherlands Local Institution - 0041 Veldhoven
Norway Local Institution - 0098 Bergen
Norway Local Institution - 0109 Oslo
Poland Local Institution - 0150 Gdansk
Poland Local Institution - 0149 Krakow
Poland Local Institution - 0152 Warszawa
Romania Local Institution - 0156 Craiova
Romania Local Institution - 0153 Romania
South Africa Local Institution - 0181 Cape Town Western CAPE
South Africa Local Institution - 0148 Johannesburg Gauteng
South Africa Local Institution - 0146 Kraaifontein Western Cape
South Africa Local Institution - 0145 Pretoria Gauteng
South Africa Local Institution - 0147 Saxonwold, Johannesburg Gauteng
Spain Local Institution - 0120 Barcelona
Spain Local Institution - 0119 Madrid
Spain Local Institution - 0121 Sevilla
Spain Local Institution - 0122 Valencia
Sweden Local Institution - 0050 Gothenberg
Sweden Local Institution - 0096 Lund
Switzerland Local Institution - 0167 Zuerich
Taiwan Local Institution - 0131 Kaohsiung
Taiwan Local Institution - 0132 Taichung
Taiwan Local Institution - 0130 Taoyuan
United Kingdom Local Institution - 0057 Bristol Avon
United Kingdom Local Institution - 0097 Leicester
United Kingdom Local Institution - 0165 London Greater London
United Kingdom Local Institution - 0054 Manchester Greater Manchester
United Kingdom Local Institution - 0060 Newcastle Upon Tyne Tyne And Wear
United Kingdom Local Institution - 0177 Northwood Middlesex
United Kingdom Local Institution - 0055 Oxford Oxfordshire
United Kingdom Local Institution - 0056 Southampton Hampshire
United Kingdom Local Institution - 0053 Surrey
United Kingdom Local Institution - 0052 Swansea Carmarthenshire
United States Local Institution - 0022 Allentown Pennsylvania
United States Local Institution - 0015 Ann Arbor Michigan
United States Local Institution - 0016 Atlanta Georgia
United States Local Institution - 0010 Aurora Colorado
United States Local Institution - 0001 Bethlehem Pennsylvania
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 - 0026 Charleston South Carolina
United States Local Institution - 0003 Charlotte North Carolina
United States Local Institution - 0027 Charlottesville Virginia
United States Local Institution - 0106 Chicago Illinois
United States Local Institution - 0157 Columbus Ohio
United States Local Institution - 0005 Dallas Texas
United States Local Institution - 0025 Durham North Carolina
United States Local Institution - 0002 Fridley Minnesota
United States Local Institution - 0123 Hackensack New Jersey
United States Local Institution - 0012 Jacksonville Florida
United States Local Institution - 0117 La Jolla California
United States Local Institution - 0036 Little Rock Arkansas
United States Local Institution - 0189 Los Angeles California
United States Local Institution - 0019 Miami Beach Florida
United States Local Institution - 0014 Nashville Tennessee
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 - 0030 Orlando Florida
United States Local Institution - 0029 Portland Oregon
United States Local Institution - 0031 Portland Oregon
United States Local Institution - 0017 Saint Louis Missouri
United States Local Institution - 0006 San Francisco California
United States Local Institution - 0021 San Francisco California
United States Local Institution - 0126 Seattle Washington
United States Local Institution - 0032 Tampa Florida
United States Local Institution - 0004 Washington District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
Bristol-Myers Squibb Ono Pharmaceutical Co. Ltd

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Canada,  Czechia,  Finland,  France,  Greece,  Hungary,  Ireland,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Norway,  Poland,  Romania,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to 36 months
Secondary Overall Survival (OS) OS is defined as as the time between the date of randomization and the date of death. up to 60 months
Secondary 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 reported between first dose and 30 days after last dose of study therapy
Secondary 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 reported between the first dose and 30 days after last dose of study therapy
Secondary 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 reported between first dose and 30 to 100 days after last dose of study therapy
Secondary 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. reported after first dose and within 30 days of last dose of the study therapy
Secondary Recurrence-free Survival by PD-L1 Expression Recurrence-free survival by PD-L1 Expression(5% tumor cell membrane expression) up to 36 months
Secondary 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.
up to 36 months
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