Melanoma Clinical Trial
Official title:
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
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 | Recruiting |
| Enrollment | 100 |
| Est. completion date | August 31, 2027 |
| Est. primary completion date | August 29, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution - 0024 | Cipolletti | R |
| Argentina | Local Institution - 0001 | Rosario | S |
| Argentina | Local Institution - 0002 | Viedma | R |
| Chile | Servicios Medicos e Investigacion Biocenter SpA | Concepcion | |
| Chile | Local Institution - 0015 | Las Condes | Santiago |
| Chile | Local Institution - 0016 | Las Condes | |
| Greece | Local Institution - 0014 | Athens | I |
| Greece | Metropolitan General Hospital | Holargos, Athens | |
| Greece | Local Institution - 0031 | Kifisia | I |
| Greece | Athens Medical Center | Marousi | I |
| Greece | Metropolitan Hospital, Department of Oncology | Peiraias | |
| Greece | Bioclinic of Thessaloniki | Thessaloniki | B |
| Greece | Local Institution - 0033 | Thessaloniki | |
| Italy | ASST Papa Giovanni XXIII | Bergamo | BG |
| Italy | Local Institution - 0035 | Meldola | FC |
| Italy | Istituto Europeo di Oncologia | Milan | MI |
| Italy | Local Institution - 0026 | Napoli | |
| Italy | Local Institution - 0012 | Padova | PD |
| Italy | Istituto Nazionale Tumori Regina Elena | Roma | RM |
| Italy | Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino | Torino | TO |
| Spain | Local Institution - 0020 | Badalona | |
| Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | B |
| Spain | Local Institution - 0022 | Barcelona | B |
| Spain | Local Institution - 0027 | Cantabria | |
| Spain | Hospital Universitario Virgen Arrixaca | Cartagena | MU |
| Spain | Hospital San Pedro de Alcántara | San Pedro Alcántara, Málaga | |
| Spain | Hospital Universitario Virgen del Rocío | Sevilla | |
| United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
| United States | Alaska Oncology & Hematology, LLC | Anchorage | Alaska |
| United States | Local Institution - 0034 | Atlanta | Georgia |
| United States | Saint Elizabeth Healthcare | Edgewood | Kentucky |
| United States | Icahn School of Medicine at Mount Sinai (ISMMS) - The Derald H. Ruttenberg Treatment Center | New York | New York |
| United States | Mayo Clinic Hospital - Phoenix | Phoenix | Arizona |
| United States | University of California, San Francisco, Medical Center at Mount Zion | San Francisco | California |
| United States | Swedish Cancer Institute | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Argentina, Chile, Greece, Italy, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants that prefer subcutaneous (SC) route of administration as assessed by Question 7 of the Patient Experience and Preference Questionnaire (PEPQ) | At Cycle 4 Day 1 (each cycle is 28 days) | ||
| Secondary | Number of participants with Adverse Events (AEs) | Up to approximately 2.5 years | ||
| Secondary | Number of participants with Serious AEs (SAEs) | Up to approximately 2.5 years | ||
| Secondary | Number of participants with treatment-related AEs | Up to approximately 2.5 years | ||
| Secondary | Number of participants with AEs leading to discontinuation | Up to approximately 2.5 years | ||
| Secondary | Number of participants with Immune-mediated AEs (IMAEs) | Up to approximately 2.5 years | ||
| Secondary | Number of participants with other events of special interest (OESIs) | Up to approximately 2.5 years | ||
| Secondary | Number of participants with injection/infusion-related AEs | Up to approximately 2.5 years | ||
| Secondary | Number of deaths | Up to approximately 2.5 years | ||
| Secondary | Number of participants with laboratory abnormalities | Up to approximately 2.5 years |
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