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NCT06101134Active, not recruitingPhase 2

A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations

A Phase 2 Open-label, Two-cohort Study to Evaluate Patient Preference for Nivolumab + Relatlimab Fixed-dose Combination Subcutaneous Versus Nivolumab + Relatlimab Fixed-dose Combination Intravenous and Nivolumab Subcutaneous Versus Nivolumab Intravenous in Participants With Melanoma

Source: ClinicalTrials.gov · Last updated 14 Sept 2026

Brief summary (registry, in English)

The purpose of this study is to assess the patient's preference for nivolumab subcutaneous (SC) or nivolumab + relatlimab fixed-dose combination (FDC) SC and provide patient experience data by route of administration. This study will also generate safety data which will further characterize the safety profile of patients switching the route of administration from intravenous (IV) to SC.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
100 (actual)
First submitted
20 Oct 2023
Start date
6 Nov 2023
Primary completion date
10 Apr 2025
Lead sponsor
Bristol-Myers Squibb
Diseases
Melanoma
NCT number
NCT06101134
EU CT number
2023-504515-33-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 100
  • From 6 Nov 2023 to the primary completion date, 10 Apr 2025
  • 30 sites in 5 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

  • Must not have any brain cancer/disease treated with radiation, any cancer in the eyes or mucous membranes (cells that cover inside surface of parts of the body and keep it moist), any autoimmune disease, or any condition that is being treated with steroids for inflammation (corticosteroids) or medication to decrease the body's immune system response (immunosuppressive drugs)
    • Other protocol-defined inclusion/exclusion criteria apply.

Who the study is looking for

  • Must have either metastatic melanoma and have not had previous treatment for their cancer, or resected melanoma and have had the cancer removed fully with surgery no later than 12 weeks before the start of treatment and confirmed free of disease
  • Must have a low level of disability and cancer that is considered advanced for metastatic melanoma and at risk for becoming advanced (intermediate) or advanced for resected melanoma

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (30)

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

SiteCityCountrySite status
Local Institution - 0005
Coordinator of this site? Confirm its status
ConcepciónChileUnknown status
Local Institution - 0015
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Las CondesChileUnknown status
Institut Catala d'Oncologia
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BadalonaSpainActive, not recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainActive, not recruiting
Hospital San Pedro De Alcántara
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CáceresSpainActive, not recruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainActive, not recruiting
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainActive, not recruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Laiko General Hospital of Athens
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AthensGreeceActive, not recruiting
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
Coordinator of this site? Confirm its status
CholargosGreeceActive, not recruiting
General Hospital Of Thessaloniki Papageorgiou
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EfkarpiaGreeceActive, not recruiting
Athens Medical Center S.A.
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MaroussiGreeceActive, not recruiting
Metropolitan Hospital
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PireasGreeceActive, not recruiting
Azienda Ospedaliera Papa Giovanni XXIII
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BergamoItalyActive, not recruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
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MeldolaItalyActive, not recruiting
European Institute Of Oncology S.r.l.
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MilanItalyActive, not recruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyActive, not recruiting
Istituto Oncologico Veneto
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PadovaItalyActive, not recruiting
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyActive, not recruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyActive, not recruiting
Local Institution - 0028
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AlbuquerqueUnited StatesUnknown status
Local Institution - 0007
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AnchorageUnited StatesUnknown status
Local Institution - 0034
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AtlantaUnited StatesUnknown status
Local Institution - 0032
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EdgewoodUnited StatesUnknown status
Local Institution - 0037
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EdmondsUnited StatesUnknown status
Local Institution - 0036
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IssaquahUnited StatesUnknown status
Local Institution - 0013
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PhoenixUnited StatesUnknown status
Local Institution - 0010
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status
Local Institution - 0030
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status

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