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- Ensaio Clínico NCT02386111
A Study of Varlilumab (Anti-CD27) and Sunitinib in Patients With Metastatic Clear Cell Renal Cell Carcinoma
A Phase l/ll Study of Varlilumab in Combination With Sunitinib in Patients With Metastatic Clear Cell Renal Cell Carcinoma
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Varlilumab is a fully human monoclonal antibody that binds to a molecule called CD27 found on certain immune cells and may act to promote anti-tumor effects.
Sunitinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) some of which play a role in tumor growth and progression of cancer.
This study will evaluate the safety, tolerability and efficacy of the anti-CD27 antibody varlilumab in combination with sunitinib.
Eligible patients that enroll in the dose escalation portion of the study will be assigned to one of three dose levels of varlilumab in combination with 50 mg of sunitinib. The first phase of the study will test the safety profile of the combination and determine which dose of varlilumab will be studied in Phase ll* of the overall study.
*Note: This Study was terminated prior to initiation of Phase II.
All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- University of Alabama at Birmingham
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California
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Sacramento, California, Estados Unidos, 95817
- UC Davis Comprehensive Cancer Center
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San Francisco, California, Estados Unidos, 94158
- UCSF Helen Diller Comprehensive Cancer Center
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20037
- George Washington University-Medical Faculty Associates
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan
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Detroit, Michigan, Estados Unidos, 48201
- Barbara Ann Karmanos Cancer Institute
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68130
- Nebraska Cancer Specialists
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New York
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New York, New York, Estados Unidos, 10029
- Mount Sinai Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Thomas Jefferson University
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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 confirmed diagnosis of predominant clear cell renal cell carcinoma.
- Advanced metastatic disease
- Documented progressive disease based on radiographic, clinical or pathologic assessment during or subsequent to last therapy.
- For Phase l, no more than 3 prior anticancer regimens (IL-2 or interferon do not count towards the total).
- Measurable (target) disease.
- Life expectancy ≥ 12 weeks.
- If of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 70 days following last treatment dose.
- Must have available tumor tissue and consent to biopsy while on study.
Exclusion Criteria:
- Prior therapy with an anti-CD27 antibody.
- Previous treatment with sunitinib.
- Use of any experimental immunotherapy.
- Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to the planned start of study treatment.
- Systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks, or radiopharmaceuticals (strontium, samarium) within 8 weeks prior to the first dose of study treatment.
- Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to first dose of study treatment.
- Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers; or any other cancer from which the patient has been disease-free for at least 3 years.
- Active, untreated central nervous system metastases.
- Active autoimmune disease or a documented history of autoimmune disease.
- Active diverticulitis.
- Significant cardiovascular disease including CHF or poorly controlled hypertension.
- Impairment of gastrointestinal function or gastrointestinal disease that may alter the absorption of sunitinib.
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 |
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Experimental: Varlilumab and Sunitinib
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During the treatment phase of the study, eligible patients will receive varlilumab for up to 8 cycles. Treatment cycles are 6 weeks each with varlilumab administered once every 3 weeks and sunitinib administered daily for 4 weeks followed by a 2 week rest. There is no limit on the number of cycles of sunitinib. Patients may be discontinued from receiving study treatment (sunitinib or varlilumab) based on the results of disease assessments or if experiencing side effects that make study therapy intolerable. Phase l Dose: The planned dose of varlilumab will be dependent on the cohort assigned at enrollment. Varlilumab doses are 0.3 mg/kg, 1 mg/kg or 3 mg/kg. The Study was terminated prior to initiation of Phase II. All patients will receive sunitinib at a dose of 50 mg. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Phase 1: Safety and tolerability of varlilumab and varlilumab in combination with sunitinib as measured by incidence of drug related adverse events (AEs), serious drug related AEs, dose-limiting toxicities and laboratory test abnormalities.
Prazo: Safety follow-up is 100 days from last study drug dose.
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Safety follow-up is 100 days from last study drug dose.
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
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
- Adenocarcinoma
- Neoplasias Glandulares e Epiteliais
- Neoplasias
- Neoplasias Renais
- Carcinoma de Células Renais
- Doenças renais
- Carcinoma
- Neoplasias Urológicas
- Neoplasias por Tipo Histológico
- Neoplasias urogenitais
- Doenças Urológicas
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Agentes Antineoplásicos
- Inibidores de angiogênese
- Agentes Moduladores da Angiogênese
- Substâncias de crescimento
- Inibidores de crescimento
- Inibidores de proteína quinase
- Sunitinibe
Outros números de identificação do estudo
- CDX1127-04
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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