Hepzato Kit e Opdualag para Melanoma Metastático e Metástases Hepáticas
Um Ensaio de Fase 1b/2 a Avaliar a Segurança, Tolerabilidade e Eficácia Preliminar da Terapia de Perfusão Hepática Percutânea com Melfalano (HEPZATO KIT™) com Nivolumab e Relatlimab (Opdualag) em Doentes com Melanoma Metastático e Metástases Hepáticas
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Cancer Connect
- Número de telefone: 800-622-8922
- E-mail: clinicaltrials@cancer.wisc.edu
Locais de estudo
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792
- Recrutamento
- UW Hospital and Clinics
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Participantes com Melanoma Metastático
|
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.
Outros nomes:
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
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidência de Eventos Adversos Emergentes do Tratamento
Prazo: até 2 anos
|
até 2 anos
|
|
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Incidência de Eventos Adversos Graves Emergentes do Tratamento
Prazo: até 2 anos
|
até 2 anos
|
|
|
Número de Participantes que Descontinuam o Tratamento devido a Eventos Adversos
Prazo: até 2 anos
|
até 2 anos
|
|
|
Incidence and Severity of Dose Limiting Toxicities (DLTs)
Prazo: up to 12 weeks
|
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
|
|
Overall Response Rate (ORR)
Prazo: After treatment plus follow up for 2 years (up to 4 years)
|
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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Número de Participantes com Redução do Tumor em qualquer momento
Prazo: Após tratamento mais acompanhamento durante 2 anos (até 4 anos)
|
Após tratamento mais acompanhamento durante 2 anos (até 4 anos)
|
|
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ORR in Hepatic and Non-Hepatic Lesions
Prazo: After treatment plus follow up for 2 years (up to 4 years)
|
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)
|
|
Disease Control Rate (DCR)
Prazo: After treatment plus follow up for 2 years (up to 4 years)
|
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)
|
|
Progression Free Survival (PFS)
Prazo: After treatment plus follow up for 2 years (up to 4 years)
|
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)
|
|
Overall Survival (OS)
Prazo: After treatment plus follow up for 2 years (up to 4 years)
|
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)
|
|
Duration of Response (DOR)
Prazo: After treatment plus follow up for 2 years (up to 4 years)
|
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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Neoplasias por local
- Neoplasias
- Neoplasias por Tipo Histológico
- Doenças de pele
- Tumores Neuroectodérmicos
- Neoplasias, Células Germinativas e Embrionárias
- Neoplasias, Tecido Nervoso
- Tumores Neuroendócrinos
- Nevos e Melanomas
- Neoplasias Cutâneas
- Doenças da Pele e do Tecido Conjuntivo
- Melanoma
- Aminoácidos, peptídeos e proteínas
- Proteínas
- Anticorpos, monoclonais, humanizados
- Anticorpos, monoclonais
- Anticorpos
- Imunoglobulinas
- Imunoproteínas
- Proteínas sanguíneas
- Globulinas de soro
- Globulins
- Nivolumabe
- relatlimab
- Opdualag
Outros números de identificação do estudo
- 2025-1424
- SMPH/MEDICINE/HEM-ONC (Outro identificador: UW Madison)
- UW25072 (Outro identificador: OnCore ID)
- Protocol Version 6/23/26 (Outro identificador: UW Madison)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
Critérios de acesso de compartilhamento 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 informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
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