Melanoma Clinical Trial
— CheckMate 238Official 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)
| Verified date | January 2024 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb | Ono Pharmaceutical Co. Ltd |
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,
| 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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