Melanoma Clinical Trial
— RELATIVITY-098Official title:
A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab + Relatlimab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV Melanoma
| Verified date | September 2023 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.
| Status | Active, not recruiting |
| Enrollment | 1050 |
| Est. completion date | November 1, 2029 |
| Est. primary completion date | February 15, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility | Inclusion Criteria: - Must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by American Joint Committee on Cancer (AJCC) v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible - Participants = 18 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status of = 1. Adolescent participants between 12 and < 18 years of age must have a Lansky/Karnofsky performance score = 80% - Complete resection must be performed within 90 days prior to randomization - All participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization - Tumor tissue must be provided for biomarker analyses Exclusion Criteria: - History of ocular melanoma - Untreated/unresected CNS metastases or leptomeningeal metastases - Active, known, or suspected autoimmune disease - Participants with serious or uncontrolled medical disorder - Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted - Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks prior to screening - History of myocarditis, regardless of etiology. Other protocol-defined inclusion/exclusion criteria apply |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution - 0003 | Buenos Aires | |
| Argentina | Clinica Adventista Belgrano-Oncology | Caba | Distrito Federal |
| Argentina | Local Institution - 0005 | Ciudad Autónoma de Buenos Aires | Distrito Federal |
| Argentina | Local Institution - 0002 | Ciudad de Buenos Aires | Distrito Federal |
| Argentina | Local Institution - 0004 | Cordoba | |
| Australia | Local Institution - 0035 | Ballarat | Victoria |
| Australia | Local Institution | Ballarat Central | Victoria |
| Australia | Local Institution - 0028 | Brisbane | Queensland |
| Australia | Local Institution - 0253 | Heidelberg | Victoria |
| Australia | Local Institution - 0031 | Melbourne | Victoria |
| Australia | Local Institution - 0251 | Murdoch | Western Australia |
| Australia | Local Institution - 0029 | Perth | Western Australia |
| Australia | Local Institution - 0027 | Southport | Queensland |
| Australia | Local Institution - 0030 | Waratah | New South Wales |
| Australia | Local Institution - 0252 | Westmead | New South Wales |
| Australia | Local Institution - 0032 | Wollstonecraft | New South Wales |
| Australia | Local Institution - 0250 | Woodville | South Australia |
| Austria | Local Institution - 0082 | Graz | Steiermark |
| Austria | Local Institution - 0086 | Salzburg | |
| Austria | Local Institution - 0084 | Vienna | |
| Belgium | Local Institution - 0110 | Brussels | |
| Belgium | Local Institution - 0105 | Bruxelles | |
| Belgium | Local Institution - 0109 | Liège | |
| Belgium | Local Institution - 0106 | Wilrijk | |
| Brazil | Local Institution - 0070 | Barretos | SAO Paulo |
| Brazil | Local Institution - 0047 | Belo Horizonte | Minas Gerais |
| Brazil | Local Institution - 0072 | Fortaleza | Ceara |
| Brazil | Local Institution - 0056 | Ijui | Rio Grande Do Sul |
| Brazil | Local Institution - 0049 | Porto Alegre | RIO Grande DO SUL |
| Brazil | Local Institution - 0257 | Porto Alegre | RIO Grande DO SUL |
| Brazil | Local Institution - 0058 | Rio de Janeiro | |
| Brazil | Local Institution - 0071 | Salvador | Bahia |
| Brazil | Local Institution - 0048 | Santa Cruz do Sul | RIO Grande DO SUL |
| Brazil | Local Institution - 0068 | Vitória | Espirito Santo |
| Canada | Local Institution - 0155 | Edmonton | Alberta |
| Canada | Local Institution - 0197 | Halifax | Nova Scotia |
| Canada | Local Institution - 0158 | Montreal | Quebec |
| Canada | Local Institution - 0159 | Montréal | Quebec |
| Canada | Local Institution - 0160 | Quebec City | Quebec |
| Canada | Local Institution - 0198 | Sherbrooke | Quebec |
| Canada | Local Institution - 0175 | Vancouver | British Columbia |
| Chile | Local Institution - 0006 | Santiago | Metropolitana |
| Chile | Local Institution - 0013 | Santiago | Metropolitana |
| Chile | Local Institution - 0014 | Santiago | Metropolitana |
| China | Local Institution - 0214 | Beijing | Beijing |
| China | Local Institution - 0259 | Beijing | Beijing |
| China | Local Institution - 0261 | Beijing | Beijing |
| China | Local Institution - 0219 | Changchun | Jilin |
| China | Local Institution - 0234 | Changsha Shi | Hunan |
| China | Local Institution - 0230 | Chengdu | Sichuan |
| China | Local Institution - 0241 | Chongqing | Chongqing |
| China | Local Institution - 0245 | Fuzhou City | Fujian |
| China | Local Institution - 0217 | Guangzhou | Guangdong |
| China | Local Institution - 0216 | Hangzhou | Zhejiang |
| China | Local Institution - 0222 | Kunming | Yunnan |
| China | Local Institution - 0224 | Nanchang | Jiangxi |
| China | Local Institution - 0215 | Nanjing | Jiangsu |
| China | Local Institution - 0242 | Shenyang | Liaoning |
| China | Local Institution - 0244 | Taiyuan | |
| China | Local Institution | Tianjin | Tianjin |
| China | Local Institution - 0228 | Urumqi | Xinjiang |
| China | Local Institution - 0237 | Wuhan | Hubei |
| China | Local Institution - 0239 | Wuhan | Hubei |
| China | Local Institution - 0226 | Zhengzhou Shi | Henan |
| Czechia | Local Institution - 0156 | Brno | |
| Czechia | Local Institution - 0091 | Hradec Kralove | |
| Czechia | Local Institution - 0026 | Ostrava | |
| Czechia | Local Institution - 0062 | Prague | |
| Denmark | Local Institution - 0022 | Aalborg | |
| Denmark | Local Institution - 0018 | Copenhagen | |
| Denmark | Local Institution - 0020 | Odense | |
| Finland | Local Institution - 0007 | Helsinki | |
| Finland | Local Institution - 0019 | Tampere | |
| Finland | Local Institution - 0015 | Turku | |
| France | Local Institution - 0043 | Dijon | |
| France | Local Institution - 0044 | Marseille | |
| France | Local Institution - 0039 | Nantes | |
| France | Local Institution - 0042 | Paris | |
| France | Local Institution - 0041 | Pierre-Bénite | |
| France | Local Institution - 0046 | Toulouse | |
| France | Local Institution - 0040 | Villejuif | Val-de-Marne |
| Germany | Local Institution - 0073 | Buxtehude | |
| Germany | Local Institution - 0077 | Dresden | |
| Germany | Local Institution - 0074 | Erlangen | |
| Germany | Local Institution - 0131 | Essen | |
| Germany | Local Institution - 0081 | Gera | |
| Germany | Local Institution - 0079 | Hannover | Lower Saxony |
| Germany | Local Institution - 0075 | Heidelberg | |
| Germany | Local Institution - 0078 | Lübeck | |
| Germany | Local Institution - 0083 | Minden | |
| Germany | Local Institution - 0076 | Munich | |
| Germany | Local Institution - 0092 | Tübingen | Baden-Württemberg |
| Germany | Local Institution - 0080 | Wuerzburg | |
| Greece | Local Institution - 0114 | Athens | |
| Greece | Local Institution - 0113 | Neo Faliro | |
| Greece | Local Institution - 0112 | Thessaloniki | |
| Israel | Local Institution - 0116 | Afula | |
| Israel | Local Institution - 0118 | Jerusalem | Yerushalayim |
| Israel | Local Institution - 0199 | Ramag Gan | |
| Israel | Local Institution - 0117 | Ramat Gan | |
| Italy | Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | |
| Italy | Istituto Europeo di Oncologia IRCCS | Milano | |
| Italy | Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapie | Napoli | |
| Italy | Istituto Oncologico Veneto IRCCS-Oncologia del Melenoma | Padova | |
| Italy | Azienda Ospedaliera Di Perugia | Perugia | |
| Italy | ospedale le scotte-U.O.C. Immunoterapia Oncologica | Siena | |
| Mexico | Local Institution - 0100 | Benito Juarez | Distrito Federal |
| Mexico | Local Institution - 0093 | Mexico | Nuevo LEON |
| Mexico | Local Institution - 0098 | Oaxaca | |
| Mexico | Local Institution - 0021 | Zapopan | Jalisco |
| Norway | Local Institution - 0009 | Lørenskog | Akershus |
| Norway | Local Institution - 0017 | Oslo | |
| Norway | Local Institution - 0023 | Stavanger | |
| Romania | Local Institution - 0170 | Brasov | |
| Romania | Local Institution - 0065 | Cluj | |
| Romania | Local Institution - 0066 | Craiova | |
| Romania | Local Institution - 0064 | Floresti/ Cluj | |
| Spain | Local Institution - 0188 | Badajoz | |
| Spain | Local Institution - 0201 | Barcelona | |
| Spain | Local Institution - 0153 | Granada | |
| Spain | Local Institution - 0150 | Madrid | |
| Spain | Local Institution - 0151 | San Sebastian | |
| Spain | Local Institution - 0152 | València | |
| Sweden | Local Institution - 0010 | Gothenburg | |
| Sweden | Local Institution - 0011 | Lund | |
| Sweden | Local Institution - 0012 | Solna | |
| Switzerland | Local Institution - 0085 | Basel | |
| Switzerland | Local Institution - 0087 | Chur | |
| Switzerland | Local Institution - 0090 | Zürich | |
| United Kingdom | Local Institution - 0102 | Bristol | |
| United Kingdom | Local Institution - 0187 | Glasgow | Lanarkshire |
| United Kingdom | Local Institution - 0154 | Newcastle upon Tyne | |
| United Kingdom | Local Institution - 0101 | Nottingham | Nottinghamshire |
| United Kingdom | Local Institution - 0232 | Oxford | |
| United Kingdom | Local Institution - 0127 | Southampton | |
| United States | Local Institution - 0267 | Allentown | Pennsylvania |
| United States | Local Institution - 0258 | Ann Arbor | Michigan |
| United States | Local Institution - 0148 | Atlanta | Georgia |
| United States | Local Institution - 0191 | Atlanta | Georgia |
| United States | Local Institution - 0138 | Aurora | Colorado |
| United States | Local Institution - 0146 | Austin | Texas |
| United States | Local Institution - 0176 | Birmingham | Alabama |
| United States | Local Institution - 0171 | Charleston | South Carolina |
| United States | Local Institution - 0130 | Charlotte | North Carolina |
| United States | Local Institution - 0202 | Chicago | Illinois |
| United States | Local Institution - 0141 | Cleveland | Ohio |
| United States | Local Institution - 0163 | Dallas | Texas |
| United States | Local Institution - 0145 | Durham | North Carolina |
| United States | Local Institution - 0137 | Fairfax | Virginia |
| United States | Local Institution - 0223 | Fort Wayne | Indiana |
| United States | Local Institution - 0147 | Germantown | Tennessee |
| United States | Local Institution | Grand Rapids | Michigan |
| United States | Local Institution - 0139 | Hackensack | New Jersey |
| United States | Local Institution - 0172 | Houston | Texas |
| United States | University of Iowa-Holden Comprehensive Cancer Center | Iowa City | Iowa |
| United States | Local Institution - 0200 | Los Angeles | California |
| United States | Local Institution | Miami | Florida |
| United States | Local Institution - 0243 | Miami | Florida |
| United States | Local Institution - 0133 | Minneapolis | Minnesota |
| United States | Local Institution - 0206 | Morristown | New Jersey |
| United States | Local Institution - 0183 | Nashville | Tennessee |
| United States | Local Institution - 0140 | New York | New York |
| United States | Local Institution - 0210 | New York | New York |
| United States | Local Institution - 0185 | Palo Alto | California |
| United States | Local Institution - 0179 | Pensacola | Florida |
| United States | Local Institution - 0177 | Peoria | Illinois |
| United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
| United States | Local Institution - 0125 | Pittsburgh | Pennsylvania |
| United States | Local Institution - 0162 | San Francisco | California |
| United States | Local Institution - 0164 | Springdale | Arkansas |
| United States | Local Institution - 0166 | Washington | District of Columbia |
| United States | Local Institution - 0178 | Westwood | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, Denmark, Finland, France, Germany, Greece, Israel, Italy, Mexico, Norway, Romania, Spain, Sweden, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Recurrence-Free Survival (RFS) time per Investigator assessment | Approximately 52 months | ||
| Secondary | Overall Survival (OS) | Approximately 90 months | ||
| Secondary | Distant Metastasis-Free Survival (DMFS) time per Investigator assessment | Approximately 90 months | ||
| Secondary | Incidence of Adverse Events (AEs) | 30 days from participant's last dose | ||
| Secondary | Severity of AEs | 30 days from participant's last dose | ||
| Secondary | Incidence of Serious Adverse Events (SAEs) | 30 days from participant's last dose | ||
| Secondary | Severity of SAEs | 30 days from participant's last dose | ||
| Secondary | Incidence of AEs leading to discontinuation (DC) | 30 days from participant's last dose | ||
| Secondary | Severity of AEs leading to DC | 30 days from participant's last dose | ||
| Secondary | Incidence of immune-mediated AEs (IMAEs) | 135 days from participant's last dose | ||
| Secondary | Severity of IMAEs | 135 days from participant's last dose | ||
| Secondary | Incidence of drug related AEs | 30 days from participant's last dose | ||
| Secondary | Severity of drug related AEs | 30 days from participant's last dose | ||
| Secondary | Incidence of deaths | 30 days from participant's last dose | ||
| Secondary | Incidence of clinically significant changes in clinical laboratory values: Hematology tests | 30 days from participant's last dose | ||
| Secondary | Incidence of clinically significant changes in clinical laboratory values: Chemistry tests | 30 days from participant's last dose | ||
| Secondary | Progression-Free Survival 2 (PFS2) | Approximately 52 months |
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