Hepzato Kit y Opdualag para Melanoma Metastásico y Metástasis Hepática
Un ensayo de fase 1b/2 que evalúa la seguridad, tolerabilidad y eficacia preliminar de la terapia de perfusión hepática percutánea con melfalán (HEPZATO KIT™) con nivolumab y relatlimab (Opdualag) en pacientes con melanoma metastásico y metástasis hepática
This study is being done to see if combining HEPZATO KIT™ with nivolumab and relatlimab (Opdualag™) in patients with metastatic melanoma with liver metastasis is safe, tolerable, and will have a synergistic effect leading to improved clinical outcomes compared to the historic cohort of patients with liver metastasis treated with combination immune checkpoint inhibitor therapy.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Co-Primary Objectives
- To evaluate the safety and tolerability of HEPZATO KIT™ in combination with nivolumab and relatlimab (Opdualag™) in subjects with metastatic melanoma and liver metastasis (LM).
- To evaluate the preliminary systemic efficacy of HEPZATO KIT™ in combination with nivolumab and relatlimab (Opdualag™), as measured by objective response rate (ORR), in subjects with metastatic melanoma and LM.
Secondary Objectives
- To evaluate the preliminary systemic efficacy of HEPZATO KIT™ in combination with nivolumab and relatlimab (Opdualag™), as measured by ORR, in both hepatic and non-hepatic target lesions in subjects with metastatic melanoma and LM.
- To evaluate the disease control rate (DCR) in subjects with metastatic melanoma and LM receiving HEPZATO KIT™ in combination with nivolumab and relatlimab (Opdualag™).
- To evaluate the PFS in subjects with metastatic melanoma and LM receiving HEPZATO KIT™ in combination with nivolumab and relatlimab (Opdualag™).
- To evaluate the overall survival (OS) in subjects with metastatic melanoma and LM receiving HEPZATO KIT™ in combination with nivolumab and relatlimab (Opdualag™).
- To evaluate the duration of response (DOR) in subjects with metastatic melanoma and LM receiving HEPZATO KIT™ in combination with nivolumab and relatlimab (Opdualag™).
- To evaluate the tumor reduction at any time during treatment in subjects with metastatic melanoma and LM receiving HEPZATO KIT™ in combination with nivolumab and relatlimab (Opdualag™).
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Cancer Connect
- Número de teléfono: 800-622-8922
- Correo electrónico: clinicaltrials@cancer.wisc.edu
Ubicaciones de estudio
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792
- Reclutamiento
- UW Hospital and Clinics
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Histologically or cytologically confirmed metastatic melanoma with liver metastasis (LM). Liver biopsy positive for presence of melanoma metastases is required.
- 0-1 line of prior systemic therapy in the unresectable/metastatic setting - prior adjuvant anti-programmed cell death-1 (anti-PD-1) or BRAF/MEK targeted therapy is considered 1 line of prior systemic therapy if less than 6 months from the last treatment.
- Evaluable/measurable disease according to RECIST v1.1.
- Demonstrate adequate organ function; all screening labs to be obtained within 28 days prior to registration.
- Patients must weigh greater than or equal to 35 kilograms (due to possible size limitations with respect to percutaneous catheterization of the femoral artery and vein using the Delcath Hepatic Delivery System).
Exclusion Criteria:
- Prior treatment with HEPZATO KIT™ or nivolumab and relatlimab (Opdualag™)
- Radiotherapy is permitted within 30 days prior to C1D1 as long as radiation is given with palliative intent and towards a non-target lesion.
- History of hypersensitivity or treatment discontinuation due to grade 3+ immune-related adverse events (irAEs) from prior anti-PD-(L)1 therapy. Patients who are able to successfully resume immune checkpoint therapy without recurrence of grade 3 irAEs are eligible to participate.
- Symptomatic or uncontrolled brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation.
- Prednisone use greater than or equal to 10 mg/d or equivalent
- Organ transplant recipients
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Participantes con Melanoma Metastásico
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Relatlimab is a human IgG4 LAG-3 blocking antibody. Nivolumab is a human IgG4 PD-1 blocking antibody. Nivolumab 480 mg and relatlimab 160 mg in a fixed-dose combination will be administered on Day 1 of each 28-day cycle that the participant is on treatment and will be given for up to 2 years from start of treatment.
Otros nombres:
The recommended HEPZATO dose is 3 mg/kg based on ideal body weight (IBW), infusion every 6 to 8 weeks for up to 2 total infusions
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidencia de Eventos Adversos Emergentes del Tratamiento
Periodo de tiempo: hasta 2 años
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hasta 2 años
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Incidencia de Eventos Adversos Graves Emergentes del Tratamiento
Periodo de tiempo: hasta 2 años
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hasta 2 años
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Número de participantes que interrumpen el tratamiento debido a eventos adversos
Periodo de tiempo: hasta 2 años
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hasta 2 años
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Incidence and Severity of Dose Limiting Toxicities (DLTs)
Periodo de tiempo: up to 12 weeks
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A DLT is defined as any grade 4+ non-hematologic event lasting greater than 3 days (despite appropriate medical management) considered possibly related to study treatment (HEPZATO KIT™ or Opdualag™) within 12 weeks of Cycle 1 Day 1. |
up to 12 weeks
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Overall Response Rate (ORR)
Periodo de tiempo: After treatment plus follow up for 2 years (up to 4 years)
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The objective response rate is the proportion of all participants with confirmed Partial Response (PR) or Complete Response (CR) according to RECIST 1.1, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment). |
After treatment plus follow up for 2 years (up to 4 years)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Número de participantes con reducción tumoral en cualquier momento
Periodo de tiempo: Tras el tratamiento más seguimiento durante 2 años (hasta 4 años)
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Tras el tratamiento más seguimiento durante 2 años (hasta 4 años)
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ORR in Hepatic and Non-Hepatic Lesions
Periodo de tiempo: After treatment plus follow up for 2 years (up to 4 years)
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The proportion of all participants with confirmed PR or CR according to RECIST 1.1, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment) in Hepatic and Non-Hepatic Target Lesions. |
After treatment plus follow up for 2 years (up to 4 years)
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Disease Control Rate (DCR)
Periodo de tiempo: After treatment plus follow up for 2 years (up to 4 years)
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The disease control rate is the proportion of all subjects with SD for 8 weeks, or PR, or CR according to RECIST 1.1, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment). |
After treatment plus follow up for 2 years (up to 4 years)
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Progression Free Survival (PFS)
Periodo de tiempo: After treatment plus follow up for 2 years (up to 4 years)
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A measurement from the date of randomization until the criteria for disease progression is met as defined by RECIST 1.1 or death occurs. Participants who have not progressed will be right-censored at the date of the last disease evaluation. |
After treatment plus follow up for 2 years (up to 4 years)
|
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Overall Survival (OS)
Periodo de tiempo: After treatment plus follow up for 2 years (up to 4 years)
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Overall survival is defined by the date of randomization to date of death from any cause. |
After treatment plus follow up for 2 years (up to 4 years)
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Duration of Response (DOR)
Periodo de tiempo: After treatment plus follow up for 2 years (up to 4 years)
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Duration of overall response-the period measured from the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since treatment started). |
After treatment plus follow up for 2 years (up to 4 years)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Vincent Ma, MD, UW Carbone Cancer Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Neoplasias por tipo histológico
- Enfermedades de la piel
- Tumores neuroectodérmicos
- Neoplasias De Células Germinales Y Embrionarias
- Neoplasias De Tejido Nervioso
- Tumores neuroendocrinos
- Nevos y Melanomas
- Neoplasias De La Piel
- Enfermedades de la piel y del tejido conectivo
- Melanoma
- Aminoácidos, péptidos y proteínas
- Proteínas
- Anticuerpos, monoclonales, humanizados
- Anticuerpos, monoclonal
- Anticuerpos
- Inmunoglobulinas
- Inmunoproteínas
- Proteínas de la sangre
- Globulinas séricas
- Globulinas
- Nivolumab
- relatlimab
- Opdualag
Otros números de identificación del estudio
- 2025-1424
- SMPH/MEDICINE/HEM-ONC (Otro identificador: UW Madison)
- UW25072 (Otro identificador: OnCore ID)
- Protocol Version 6/23/26 (Otro identificador: UW Madison)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Researchers must have local IRB approval for their study that is to include study of the biospecimens and accompanying data. Release of biospecimens to non-UW researchers will be performed according to all UW regulatory policies. Tissue (including blood) specimen as part of this research will be primarily stored at UW and may be sent to an outside lab/facility to achieve the objectives of the study. No study data or patient health information will be shared with a third party.
Criterios de acceso compartido de IPD
Researchers who are doing biomedical research may apply to the PI for access to blood and tissue (no patient identifiers on tubes or slides). Only de-identified information will be released with the specimens
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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