Melanoma Clinical Trial
— RELATIVITY-127Official title:
A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination Versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants With Previously Untreated Metastatic or Unresectable Melanoma
The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.
| Status | Recruiting |
| Enrollment | 570 |
| Est. completion date | February 28, 2025 |
| Est. primary completion date | February 28, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility | Inclusion Criteria - Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of = 1/Lansky Performance Score = 80% for adolescents (= 12 to < 18 years of age). - Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the American Joint Committee for Cancer (AJCC) staging system. - Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). - Participants must be = 12 years of age. Participants who are = 12 years of age and < 18 years of age (adolescents) must weigh = 40 kg at the time of signing the informed consent (assent). - Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the AJCC staging system (8th edition). Exclusion Criteria - Participants must not have ocular melanoma. - Participants must not have a history of myocarditis, regardless of etiology. - Participants must not have a condition requiring systemic treatment with either corticosteroids (>10 milligrams [mg] daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. - Other protocol-defined Inclusion/Exclusion criteria apply. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution - 0023 | Caba | Buenos Aires |
| Argentina | Local Institution - 0042 | Caba | Buenos Aires |
| Argentina | Local Institution - 0067 | Caba | Buenos Aires |
| Argentina | Local Institution - 0070 | Caba | Buenos Aires |
| Argentina | Local Institution - 0145 | Caba | Ciudad Autonoma De Buenos Aires |
| Argentina | Local Institution - 0133 | Ciudad Autonoma de Buenos Aires | Buenos Aires |
| Argentina | Local Institution - 0057 | Cordoba | |
| Argentina | Local Institution - 0160 | Rosario | Santa Fe |
| Argentina | Local Institution - 0020 | Tucuman | |
| Australia | Bendigo Health - Bendigo Cancer Centre | Bendigo | Victoria |
| Australia | Sunshine Coast University Private Hospital | Birtinya | Queensland |
| Australia | Local Institution - 0059 | Box Hill | Victoria |
| Australia | North Coast Area Health Service NCAHS - The North Coast Cancer Institute NCCI - Coffs Harbour Health Campus | Coffs Harbour | New South Wales |
| Australia | Austin Hospital - Medical Oncology Unit | Heidelberg | Victoria |
| Australia | The Alfred Hospital | Melbourne | Victoria |
| Australia | One Clinical Research | Nedlands | Western Australia |
| Australia | Sir Charles Gairdner Hospital | Nedlands | Western Australia |
| Australia | Orange Health Service | Orange | New South Wales |
| Australia | Port Macquarie Base Hospital | Port Macquarie | New South Wales |
| Australia | Latrobe Regional Health | Traralgon | Victoria |
| Australia | Riverina Cancer Care Centre | Wagga Wagga | New South Wales |
| Australia | Local Institution - 0184 | Waratah | New South Wales |
| Australia | Westmead Hospital | Westmead | New South Wales |
| Australia | University of Sydney - Melanoma Institute Australia MIA | Wollstonecraft | New South Wales |
| Australia | Local Institution - 0183 | Woodville South | South Australia |
| Austria | Local Institution - 0027 | Graz | |
| Austria | Universitatsklinik fur Dermatologie der Paracelsus medizinischen Privatuniversitat Salzburg | Salzburg | |
| Austria | Department of Dermatology, University Hospital St. Poelten | St. Polten | |
| Austria | Medizinische Universitaet WienAKH, Dpt. of Dermatology | Wien | |
| Belgium | Cliniques Universitaires Saint Luc | Brussels | |
| Belgium | Grand Hôpital de Charleroi-Oncology & Hematology | Charleroi | |
| Belgium | Local Institution - 0036 | Jette | |
| Belgium | CHU de Liege | Liege | |
| Brazil | Hospital do Amor de Barretos | Barretos | Sao Paulo |
| Brazil | Oncologia de Preciso e Personalizada | Belo Horizonte | Minas Gerais |
| Brazil | Clinica de Oncologia Reichow | Blumenau | SC |
| Brazil | Local Institution - 0147 | Curitiba | Parana |
| Brazil | Local Institution - 0132 | Florianopolis | Santa Catarina |
| Brazil | Local Institution - 0177 | Fortaleza | Ce |
| Brazil | ONCOSITE -Centro de Pesquisa Clinica em Oncologia Ltda | Ijui | Rio Grande Do Sul |
| Brazil | Local Institution - 0182 | Lages | Santa Catarina |
| Brazil | Local Institution - 0179 | Ondina | Salvador-BA |
| Brazil | Hosptial Sao Lucas da PUC de Porto Alegre | Porto Alegre | Rio Grande Do Sul |
| Brazil | UPCO - Hospital de Clinicas de Porto Alegre | Porto Alegre | RIO Grande DO SUL |
| Brazil | Hospital Nossa Senhora Da Conceicao | Porto Alegrelegre | RIO Grande DO SUL |
| Brazil | INCA- Instituto Nacional de Cancer Jose de Alencar Gomes da Silva | Rio De Janeiro | |
| Brazil | Local Institution - 0180 | Santa Cecilia | Vitoria |
| Brazil | Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto | Sao Jose do Rio Preto | Sao Paulo |
| Brazil | Local Institution - 0130 | Sao Paulo | |
| Canada | Tom Baker Cancer Centre (TBCC) - Alberta Health Services (AHS) | Calgary | Alberta |
| Canada | Juravinski Cancer Centre | Hamilton | Ontario |
| Canada | Ottawa Hospital Research Institute | Ottawa | Ontario |
| Canada | Hopital de l Enfant Jesus | Quebec | |
| Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
| Chile | Local Institution - 0178 | Puerto Montt | Los Lagos |
| Chile | Bradford Hill Centro de Investigacion Clnica | Recoleta | Metropolitana |
| Chile | Clinica San Carlos de Apoquindo | Santiago | Metropolitana |
| Chile | Clinica Vespucio | Santiago | Metropolitana |
| Chile | Fundacion Arturo Lopez Perez | Santiago | Metropolitana |
| Chile | Local Institution - 0010 | Santiago | Metropolitana |
| Chile | Local Institution - 0119 | Santiago de Chile | Providencia |
| Chile | James Lind Centro de Investigación del Cáncer | Temuco | Araucania |
| Chile | Local Institution - 0176 | Via Del Mar | Valparaso |
| Chile | Oncocentro Apys | Vina Del Mar | Valparaiso |
| Chile | Local Institution - 0142 | Vitacura | Metropolitana |
| Colombia | Local Institution - 0152 | Bogota | |
| Colombia | Local Institution - 0149 | Medellin | |
| Colombia | Local Institution - 0150 | Valledupar | |
| Czechia | University Hospital Hradec Kralove | Hradec Kralove | |
| Czechia | Fakultni nemocnice Olomouc FNOL | Olomouc | |
| Czechia | FN Ostrava | Ostrava Poruba | |
| Czechia | Fakultni Nemocnice Kralovske Vinohrady FNKV | Prague | |
| Czechia | Univerzita Karlova v Praze a Vseobecna fakultni nemocnice v Praze | Prague | NY |
| Finland | Helsinki University Hospital HUS | Helsinki | |
| Finland | Pirkanmaan Sairaanhoitopiiri - Tampereen Yliopistollinen Sairaala Tampere University Hospital - Keskussairaala | Tampere | |
| Finland | Turku University Hospital | Turku | |
| France | CHU Amiens-Picardie - Site Nord | Amiens | |
| France | Centre Hospitalier de la Cote Basque | Bayonne | |
| France | CHU de Bordeaux - Hopital Saint-Andre | Bordeaux | |
| France | Local Institution - 0127 | Chambray-les-Tours | Indre-Et-Loire |
| France | Centre Hospitalier Universitaire de Clermont Ferrand | Clermont Ferrand Cedex 1 | |
| France | CHU Dijon - Hopital Francois Mitterand | Dijon | |
| France | CHU Lille - Hopital Huriez | Lille | Nord |
| France | Local Institution - 0117 | Marseille | |
| France | Local Institution - 0190 | Marseille | |
| France | Hotel Dieu CHU Nantes | Nantes Cedex 01 | OH |
| France | Hopital Saint-Louis | Paris | Ile De France |
| France | Hopital Lyon Sud | Pierre-Benite | |
| France | Centre Eugene Marquis | Rennes Cedex | |
| France | CHU de Rouen - Hopital Charles Nicolle | Rouen | |
| France | Local Institution - 0181 | Saint Etienne | |
| France | Institut Claudius Regaud IUCT O | Toulouse | Cedex 9 |
| France | Institut Gustave Roussy | Villejuif Cedex | Val-De-Marne |
| Germany | Charite Universitaetsmedizin Berlin | Berlin | |
| Germany | Elbe Klinikum Buxtehude | Buxtehude | Niedersachsen |
| Germany | Local Institution - 0136 | Dortmund | |
| Germany | Local Institution - 0039 | Erfurt | |
| Germany | Universitaetsklinikum Essen, Klinik fuer Dermatologie | Essen | |
| Germany | Universitaetsklinikum Frankfurt Main | Frankfurt | |
| Germany | Department of Dermatology, University hospital Giessen | Giessen | |
| Germany | Local Institution - 0135 | Goettingen | |
| Germany | Universitaetsklinikum Hamburg Eppendorf - UKE, Dept of Dermatology (W14) | Hamburg | |
| Germany | Nationales Centrum fr Tumorerkrankungen NCT | Heidelberg | Baden-Wurttemberg |
| Germany | Local Institution - 0148 | Koeln | |
| Germany | Local Institution - 0137 | Ludwigshafen | |
| Germany | Universitaetsklinikum Schleswig-Holstein | Luebeck | Schleswig-Holstein |
| Germany | Universitaetsklinikum Giessen und Marburg GmbH - Klinik fuer Dermatologie Venerologie und Allergologie - Standort Marburg | Marburg | |
| Germany | Johannes Wesling Medical Center Minden | Minden | |
| Germany | Local Institution - 0076 | Munchen | |
| Germany | Studienambulanz Hautklinik Klinikum Nuernberg | Nuernberg | |
| Germany | Universittsklinikum Regensburg | Regensburg | Bayern |
| Germany | Unviersitaetsmedizin Rostock | Rostock | |
| Germany | Studienzentrum Hautklinik Tuebingen | Tuebingen | |
| Germany | Universitaetsklinikum Ulm | Ulm | Baden-Württemberg |
| Israel | Emek Medical Center | Afula | |
| Israel | Local Institution - 0054 | Jerusalem | |
| Israel | Local Institution - 0102 | Petah-Tikvah | |
| Israel | Local Institution - 0035 | Tel Hashomer | |
| Israel | Tel-Aviv Sourasky Medical Center | Tel-Aviv | |
| Italy | Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari | Bari | |
| Italy | IRCCS Ospedale Policlinico San Martino | Genova | |
| Italy | Fondazione IRCCS Istituto Nazionale Dei Tumori | Milano | Milan |
| Italy | Istituto Nazionale Tumori - Fondazione Pascale Italy | Napoli | |
| Italy | Ospedale S. Maria della Misericordia | Perugia | |
| Italy | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | |
| Italy | Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte | Siena | |
| Mexico | Local Institution - 0174 | Cancun | Quintana Roo |
| Mexico | Local Institution - 0075 | Ciudad de Mexico | Oaxaca |
| Mexico | Local Institution - 0104 | Monterrey | Nuevo Leon |
| Mexico | Local Institution - 0131 | Puebla | |
| Mexico | Local Institution - 0073 | Queretaro | |
| Mexico | Local Institution - 0001 | Zapopan | Jalisco |
| Norway | Local Institution - 0163 | Bodo | |
| Norway | Sykehuset Ostfold Kalnes | Gralum | |
| Norway | Akershus University Hospital | Lørenskog | |
| Norway | Local Institution - 0155 | Oslo | |
| Poland | Local Institution - 0187 | Bialystok | |
| Poland | Centrum Onkologii im. Prof. Franciszka Lukaszczyka | Bydgoszcz | Kujawsko-pomorskie |
| Poland | Local Institution - 0185 | Gliwice | |
| Poland | Pratia MCM Krakow | Krakow | Malopolskie |
| Poland | SPZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego | Opole | Opolskie |
| Poland | Poznan University of Medical Sciences | Poznan | Wiekopolskie |
| Poland | Maria Sklodowska-Curie National Research Institute of Oncology | Warszawa | |
| Poland | Local Institution - 0048 | Wroclaw | |
| Spain | CH Universitario de A Coruñas | A Coruna | A Coruña |
| Spain | Local Institution - 0134 | Badalona | |
| Spain | Hospital Clinic de Barcelona | Barcelona | |
| Spain | Hospital Universitario Valle de Hebron | Barcelona | |
| Spain | Onkologikoa Of San Sebastian | Donostia | Gipuzkoa |
| Spain | Local Institution - 0188 | Granada | |
| Spain | Complejo Hospitalario de Jaen | Jaen | |
| Spain | Complejo Hospitalario Materno-Insular - Hospital Insular de Gran Canaria | Las Palmas de Gran Canaria | |
| Spain | Hospital General Universitario Gregorio Maranon | Madrid | |
| Spain | Hospital Universitario 12 de Octubre | Madrid | |
| Spain | Hospital Universitario HM Sanchinarro | Madrid | |
| Spain | Local Institution - 0126 | Madrid | |
| Spain | Hospital Universitario Virgen Macarena | Sevilla | |
| Spain | Fundacin Instituto Valenciano de Oncologa | Valencia | |
| Spain | Hospital General Universitario de Valencia | Valencia | |
| Spain | Hospital Universitario La Fe Hospital La Fe Campanar | Valencia | |
| Spain | Local Institution - 0186 | Zaragoza | |
| Sweden | Local Institution - 0157 | Linkoeping | Vastergotland |
| Sweden | Skne University Hospital Lund | Lund | |
| Sweden | Karolinska Universitetssjukhuset - Solna | Solna | Stockholm |
| Sweden | Local Institution - 0069 | Uppsala | |
| Switzerland | Inselspital Bern | Bern | |
| Switzerland | Kantonsspital Graubuenden | Chur | |
| Switzerland | UNIL-CHUV Lausanne | Lausanne | |
| United Kingdom | Local Institution - 0087 | Glasgow | Strathclyde |
| United Kingdom | Local Institution - 0068 | Headington, Oxford | Oxfordshire |
| United Kingdom | Local Institution - 0085 | London | Greater London |
| United Kingdom | The Royal Marsden NHS Foundation Trust | London | Greater London |
| United Kingdom | Northern Centre for Cancer Care | Newcastle Upon Tyne | Tyne And Wear |
| United States | Greenebaum Cancer Center University of Maryland | Baltimore | Maryland |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | St. Lukes University Health Network | Easton | Pennsylvania |
| United States | The Melanoma and Skin Cancer Institute | Englewood | Colorado |
| United States | Inova Health Care Services | Fairfax | Virginia |
| United States | Ft. Wayne Medical Oncology and Hematology | Fort Wayne | Indiana |
| United States | Mayo Clinic - Jacksonville | Jacksonville | Florida |
| United States | The Angeles Clinic and Research Institute | Los Angeles | California |
| United States | Intermountain Medical Center Campus Location | Murray | Utah |
| United States | Rutgers CINJ | New Brunswick | New Jersey |
| United States | Oncology Hematology West P.C. Nebraska Cancer Specialist | Omaha | Nebraska |
| United States | UC Irvine Health | Orange | California |
| United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
| United States | Dignity Health - St. Josephs Hospital and Medical Center | Phoenix | Arizona |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | Local Institution - 0189 | Springdale | Arkansas |
| United States | Stanford Univ Med School Dept of Dermatology | Stanford | California |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czechia, Finland, France, Germany, Israel, Italy, Mexico, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time-averaged serum concentration over 28 days after the first dose (Cavgd28) of Nivolumab | Up to 28 days | ||
| Primary | Trough serum concentration at steady state (Cminss) of Nivolumab | Up to 4 months | ||
| Primary | Cavgd28 of Relatlimab | Up to 28 days | ||
| Primary | Cminss of Relatlimab | Up to 4 months | ||
| Secondary | Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) per RECIST v1.1 | Up to approximately 3 years | ||
| Secondary | Trough serum concentration at Day 28 after the first dose (Cmind28) of Nivolumab and Relatlimab | Up to 28 days | ||
| Secondary | Peak serum concentration after the first dose (Cmax1) of Nivolumab and Relatlimab | Up to 28 days | ||
| Secondary | Time to Cmax1 (Tmax1) of Nivolumab and Relatlimab | Up to 28 days | ||
| Secondary | Peak serum concentration at steady state (Cmaxss) of Nivolumab and Relatlimab | Up to 4 months | ||
| Secondary | Time-averaged serum concentration at steady state (Cavgss) of Nivolumab and Relatlimab | Up to 4 months | ||
| Secondary | Duration of Response (DOR) by BICR per RECIST v1.1 | Up to approximately 3 years | ||
| Secondary | Disease Control Rate (DCR) by BICR per RECIST v1.1 | Up to approximately 3 years | ||
| Secondary | Time to Response (TTR), by BICR per RECIST v1.1 | Up to approximately 3 years | ||
| Secondary | Objective Response Rate (ORR) by Investigator per RECIST v1.1 | Up to approximately 3 years | ||
| Secondary | DOR by Investigator per RECIST v1.1 | Up to approximately 3 years | ||
| Secondary | DCR by Investigator per RECIST v1.1 | Up to approximately 3 years | ||
| Secondary | TTR by Investigator per RECIST v1.1 | Up to approximately 3 years | ||
| Secondary | Progression Free Survival (PFS) by BICR and Investigator per RECIST v1.1 | Up to approximately 3 years | ||
| Secondary | Overall Survival | Up to approximately 3 years | ||
| Secondary | Number of Participants with Adverse Events (AEs) | Up to approximately 3 years | ||
| Secondary | Change from Baseline in Functional Assessment of Cancer Therapy - Melanoma Subscale (FACT-MS) | Up to approximately 3 years |
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