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
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 0005 Coordinator of this site? Confirm its status | Concepción | Chile | Unknown status |
| Local Institution - 0015 Coordinator of this site? Confirm its status | Las Condes | Chile | Unknown status |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital San Pedro De Alcántara Coordinator of this site? Confirm its status | Cáceres | Spain | Active, not recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Active, not recruiting |
| University Clinical Hospital Virgen De La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Active, not recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Laiko General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A. Coordinator of this site? Confirm its status | Cholargos | Greece | Active, not recruiting |
| General Hospital Of Thessaloniki Papageorgiou Coordinator of this site? Confirm its status | Efkarpia | Greece | Active, not recruiting |
| Athens Medical Center S.A. Coordinator of this site? Confirm its status | Maroussi | Greece | Active, not recruiting |
| Metropolitan Hospital Coordinator of this site? Confirm its status | Pireas | Greece | Active, not recruiting |
| Azienda Ospedaliera Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Active, not recruiting |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l Coordinator of this site? Confirm its status | Meldola | Italy | Active, not recruiting |
| European Institute Of Oncology S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Istituto Oncologico Veneto Coordinator of this site? Confirm its status | Padova | Italy | Active, not recruiting |
| I.F.O. Istituti Fisioterapici Ospitalieri Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Active, not recruiting |
| Local Institution - 0028 Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Local Institution - 0007 Coordinator of this site? Confirm its status | Anchorage | United States | Unknown status |
| Local Institution - 0034 Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Local Institution - 0032 Coordinator of this site? Confirm its status | Edgewood | United States | Unknown status |
| Local Institution - 0037 Coordinator of this site? Confirm its status | Edmonds | United States | Unknown status |
| Local Institution - 0036 Coordinator of this site? Confirm its status | Issaquah | United States | Unknown status |
| Local Institution - 0013 Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Local Institution - 0010 Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Local Institution - 0030 Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.