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NCT03470922Active, not recruitingPhase 2/3

A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma

A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Metastatic or Unresectable Melanoma

Source: ClinicalTrials.gov · Last updated 9 Sept 2025

Brief summary (registry, in English)

The purpose of this study is to determine whether relatlimab in combination with nivolumab is more effective than nivolumab monotherapy in treating unresectable melanoma or melanoma that has spread.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
714 (actual)
First submitted
14 Mar 2018
Start date
11 Apr 2018
Primary completion date
25 Jan 2021
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT03470922
EU CT number
2024-510913-13-00
EudraCT number
2017-003583-12

What you commit to

  • Study type: Interventional · Phase 2/3
  • Participants enrolled: 714
  • From 11 Apr 2018 to the primary completion date, 25 Jan 2021
  • 113 sites in 25 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.

Other illness

  • Participants must not have an active, known, or suspected autoimmune disease
    • Other protocol defined inclusion/exclusion criteria could apply

Other

  • Participants must not have active brain metastases or leptomeningeal metastases
  • Participants must not have uveal melanoma

Who the study is looking for

  • Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the AJCC staging system
  • Participants must not have had prior systemic anticancer therapy for unresectable or metastatic melanoma
  • Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses

Criteria the registry did not label

  • For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (113)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Local Institution - 0004
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Buenos AiresArgentinaUnknown status
Local Institution - 0135
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Buenos AiresArgentinaUnknown status
Local Institution - 0005
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Local Institution - 0003
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Buenos AiresArgentinaUnknown status
Local Institution - 0002
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Capital FederalArgentinaUnknown status
Medical University of Graz
Coordinator of this site? Confirm its status
GrazAustriaActive, not recruiting
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
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SalzburgAustriaActive, not recruiting
Medical University of Vienna
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ViennaAustriaActive, not recruiting
Local Institution - 0133
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Bedford ParkAustraliaUnknown status
Local Institution - 0041
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GreenslopesAustraliaUnknown status
Local Institution - 0044
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MurdochAustraliaUnknown status
Local Institution - 0042
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North SydneyAustraliaUnknown status
Local Institution - 0045
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SouthportAustraliaUnknown status
Local Institution - 0043
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WaratahAustraliaUnknown status
Universitair Ziekenhuis Gent
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GentBelgiumActive, not recruiting
Local Institution - 0058
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Belo HorizonteBrazilUnknown status
Local Institution - 0061
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Porto AlegreBrazilUnknown status
Local Institution - 0057
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Porto AlegreBrazilUnknown status
Local Institution - 0059
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Rio de JaniroBrazilUnknown status
Local Institution - 0073
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Santa Cruz do SulBrazilUnknown status
Local Institution - 0063
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São PauloBrazilUnknown status
Local Institution - 0060
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São PauloBrazilUnknown status
Local Institution - 0062
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São PauloBrazilUnknown status
Local Institution - 0124
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HalifaxCanadaUnknown status
Local Institution - 0075
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MontrealCanadaUnknown status
Local Institution - 0123
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MontrealCanadaUnknown status
Local Institution - 0068
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OttawaCanadaUnknown status
Local Institution - 0128
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TorontoCanadaUnknown status
Local Institution - 0001
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SantiagoChileUnknown status
Local Institution - 0095
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BogotáColombiaUnknown status
Local Institution - 0096
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MedellínColombiaUnknown status
Elbe Kliniken Stade-Buxtehude Elbe Klinikum Buxtehude gGmbH
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BuxtehudeGermanyActive, not recruiting
University Hospital Cologne AöR
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CologneGermanyActive, not recruiting
HELIOS Klinikum Erfurt GmbH
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ErfurtGermanyActive, not recruiting
Medizinische Hochschule Hannover
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HanoverGermanyActive, not recruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyActive, not recruiting
Universitaetsklinikum Schleswig-Holstein AöR
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LuebeckGermanyActive, not recruiting
Universitat Heidelberg
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MannheimGermanyActive, not recruiting
Klinikum rechts der Isar der TU Muenchen AöR
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MunichGermanyActive, not recruiting
Harzklinikum Dorothea Christiane Erxleben GmbH
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QuedlinburgGermanyActive, not recruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyActive, not recruiting
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyActive, not recruiting
Region Hovedstaden
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HerlevDenmarkActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Vall D'hebron Institut De Recerca
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BarcelonaSpainActive, not recruiting
Fundacion Onkologikoa Fundazioa
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DonostiaSpainActive, not recruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainActive, not recruiting
HUS-Yhtymae
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HelsinkiFinlandActive, not recruiting
Oulu University Hospital
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OuluFinlandActive, not recruiting
Tampere University Hospital
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TampereFinlandActive, not recruiting
Turku University Hospital
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TurkuFinlandActive, not recruiting
Centre Hospitalier Universitaire Amiens - Picardie
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AmiensFranceActive, not recruiting
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceActive, not recruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceActive, not recruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceActive, not recruiting
Hopital Saint Louis
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ParisFranceActive, not recruiting
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceActive, not recruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceActive, not recruiting
Centre De Lutte Contre Le Cancer Eugene Marquis
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Rennes CedexFranceActive, not recruiting
Local Institution - 0052
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BristolUnited KingdomUnknown status
Local Institution - 0054
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GlasgowUnited KingdomUnknown status
Local Institution - 0126
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InvernessUnited KingdomUnknown status
Local Institution - 0051
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LondonUnited KingdomUnknown status
Local Institution - 0056
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SwanseaUnited KingdomUnknown status
Laiko General Hospital of Athens
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AthensGreeceActive, not recruiting
Local Institution - 0086
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HaifaIsraelUnknown status
Local Institution - 0088
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JerusalemIsraelUnknown status
Local Institution - 0087
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Ramat GanIsraelUnknown status
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyActive, not recruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyActive, not recruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyActive, not recruiting
Istituto Oncologico Veneto
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PadovaItalyActive, not recruiting
Azienda Ospedaliera Universitaria Senese
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SienaItalyActive, not recruiting
Local Institution - 0093
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CancúnMexicoUnknown status
Local Institution - 0092
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MéridaMexicoUnknown status
Local Institution - 0091
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MonterreyMexicoUnknown status
Local Institution - 0129
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VeracruzMexicoUnknown status
Local Institution - 0094
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ZapopanMexicoUnknown status
Oslo University Hospital HF
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OsloNorwayActive, not recruiting
Local Institution - 0090
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DunedinNew ZealandUnknown status
Local Institution - 0125
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HamiltonNew ZealandUnknown status
Local Institution - 0089
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TaurangaNew ZealandUnknown status
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandActive, not recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandActive, not recruiting
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
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Cluj-NapocaRomaniaActive, not recruiting
Centrul De Oncologie SF Nectarie S.R.L.
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CraiovaRomaniaActive, not recruiting
Local Institution - 0113
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KrasnodarRussiaUnknown status
Local Institution - 0127
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KrasnoyarskRussiaUnknown status
Local Institution - 0112
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MoscowRussiaUnknown status
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
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GoteborgSwedenActive, not recruiting
Region Skane Skanes Universitetssjukhus
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LundSwedenActive, not recruiting
Local Institution - 0019
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AllentownUnited StatesUnknown status
Local Institution - 0015
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Ann ArborUnited StatesUnknown status
Local Institution - 0038
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AtlantaUnited StatesUnknown status
Local Institution - 0120
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BaltimoreUnited StatesUnknown status
Local Institution - 0077
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BaltimoreUnited StatesUnknown status
Local Institution - 0014
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BostonUnited StatesUnknown status
Local Institution - 0134
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BostonUnited StatesUnknown status
Local Institution - 0018
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CharlotteUnited StatesUnknown status
Local Institution - 0016
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ChicagoUnited StatesUnknown status
Local Institution - 0076
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DallasUnited StatesUnknown status
Local Institution - 0114
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Fort WayneUnited StatesUnknown status
Local Institution - 0008
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HoustonUnited StatesUnknown status
Local Institution - 0013
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JacksonvilleUnited StatesUnknown status
Local Institution - 0020
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Los AngelesUnited StatesUnknown status
Local Institution - 0009
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MinneapolisUnited StatesUnknown status
Local Institution - 0117
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OrlandoUnited StatesUnknown status
Local Institution - 0011
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RochesterUnited StatesUnknown status
Coastal Integrative Cancer Care
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San Luis ObispoUnited StatesUnknown status
Local Institution - 0116
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Santa BarbaraUnited StatesUnknown status
Local Institution - 0007
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TampaUnited StatesUnknown status
Local Institution - 0010
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TucsonUnited StatesUnknown status
Local Institution - 0012
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Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.