NCT05625399Active, not recruitingPhase 3
A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma
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
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
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 (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 579 (actual)
- First submitted
- 15 Nov 2022
- Start date
- 6 Mar 2023
- Primary completion date
- 4 Aug 2025
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Melanoma, Childhood cancers
- NCT number
- NCT05625399
- EU CT number
- 2022-500967-11-00
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 579
- From 6 Mar 2023 to the primary completion date, 4 Aug 2025
- 143 sites in 19 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 illness
- Participants must not have a history of myocarditis, regardless of etiology.
Other
- Participants must not have ocular melanoma.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Who the study is looking for
- 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).
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (143)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Noe LGA Gesundheit Region Mitte GmbH Coordinator of this site? Confirm its status | St. Poelten | Austria | Recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| - Coordinator of this site? Confirm its status | Bendigo | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Birtinya | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Box Hill | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Coffs Harbour | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Orange | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Port Macquarie | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Traralgon | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Wagga Wagga | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Waratah | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Wollstonecraft | Australia | Unknown status |
| Grand Hopital de Charleroi Coordinator of this site? Confirm its status | Charleroi | Belgium | Recruiting |
| CHU de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
| - Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Blumenau | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Fortaleza | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Ijuí | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Porto Alegrelegre | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | São José do Rio Preto | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Vitória | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| - Coordinator of this site? Confirm its status | Chur | Switzerland | Unknown status |
| - Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| - Coordinator of this site? Confirm its status | Port Montt | Chile | Unknown status |
| - Coordinator of this site? Confirm its status | Recoleta | Chile | Unknown status |
| - Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| - Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| - Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| - Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| - Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| - Coordinator of this site? Confirm its status | Temuco | Chile | Unknown status |
| - Coordinator of this site? Confirm its status | Viña del Mar | Chile | Unknown status |
| Fakultni Nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Novy Hradec Kralove | Czechia | Recruiting |
| University Hospital Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Recruiting |
| University Hospital Ostrava Coordinator of this site? Confirm its status | Ostrava-Poruba | Czechia | Recruiting |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| University Hospital Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague 10 | Czechia | Recruiting |
| Charite Universitatsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Elbe Kliniken Stade-Buxtehude Elbe Klinikum Buxtehude gGmbH Coordinator of this site? Confirm its status | Buxtehude | Germany | Recruiting |
| Klinikum Dortmund gGmbH Coordinator of this site? Confirm its status | Dortmund | Germany | Recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Goethe University Frankfurt Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Recruiting |
| Justus Liebig University Giessen Coordinator of this site? Confirm its status | Giessen | Germany | Recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Heidelberg University Hospital AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| University Medical Centre Schleswig-Holstein Coordinator of this site? Confirm its status | Lübeck | Germany | Recruiting |
| Philipps University Marburg Coordinator of this site? Confirm its status | Marburg | Germany | Recruiting |
| Muhlenkreiskliniken AöR Coordinator of this site? Confirm its status | Minden | Germany | Recruiting |
| Klinikum Nuernberg Coordinator of this site? Confirm its status | Nuremberg | Germany | Recruiting |
| Universitaetsklinikum Regensburg Coordinator of this site? Confirm its status | Regensburg | Germany | Recruiting |
| Rostock University Medical Center Coordinator of this site? Confirm its status | Rostock | Germany | Recruiting |
| Universitaetsklinikum Tuebingen Coordinator of this site? Confirm its status | Tuebingen | Germany | Recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Recruiting |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Fundacion Onkologikoa Fundazioa Coordinator of this site? Confirm its status | Donostia | Spain | Recruiting |
| Hospital Universitario de Jaén Coordinator of this site? Confirm its status | Jaén | Spain | Recruiting |
| Complejo Hospitalario Universitario Insular Materno Infantil Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Fundación Instituto Valenciano de Oncología Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| HUS Helsinki University Hospital Coordinator of this site? Confirm its status | Helsinki | Finland | Recruiting |
| Tampere University Hospital Coordinator of this site? Confirm its status | Tampere | Finland | Recruiting |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Recruiting |
| Centre Hospitalier Universitaire Amiens - Picardie Coordinator of this site? Confirm its status | Amiens | France | Recruiting |
| Centre Hospitalier de la Cote Basque Coordinator of this site? Confirm its status | Bayonne | France | Recruiting |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre Hospitalier Regional Universitaire De Tours Coordinator of this site? Confirm its status | Chambray Les Tours | France | Recruiting |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont Ferrand Cedex 1 | France | Recruiting |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Recruiting |
| Assistance Publique Hôpitaux de Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| Centre De Lutte Contre Le Cancer Eugene Marquis Coordinator of this site? Confirm its status | Rennes Cedex | France | Recruiting |
| CHU De Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Recruiting |
| Institut Claudius Regaud Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| - Coordinator of this site? Confirm its status | Headington, Oxford | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Afula | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Petah-Tikvah | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Tel HaShomer | Israel | Unknown status |
| Istituto Tumori Bari Giovanni Paolo II Coordinator of this site? Confirm its status | Bari | Italy | Recruiting |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Hospital Santa Maria Della Misericordia Coordinator of this site? Confirm its status | Perugia | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Senese Coordinator of this site? Confirm its status | Siena | Italy | Recruiting |
| Nordlandssykehuset HF Coordinator of this site? Confirm its status | Bodo | Norway | Recruiting |
| Ostfold Hospital Trust Coordinator of this site? Confirm its status | Fredrikstad | Norway | Recruiting |
| Akershus University Hospital Coordinator of this site? Confirm its status | Loerenskog | Norway | Recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Pratia MCM Krakow Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Opolskie Centrum Onkologii Im Prof Tadeusza Koszarowskiego W Opolu Coordinator of this site? Confirm its status | Opole | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Lund | Sweden | Recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Recruiting |
| - Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Easton | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Englewood | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Murray | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Springdale | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.