- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01034787
Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma
Open Label Phase II Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma
Visão geral do estudo
Descrição detalhada
This is a Phase 2, multi-center, open-label study in patients with surgically incurable stage III or IV uveal melanoma who have not received prior immunotherapy. Patients may have received prior chemotherapy or biological therapy for the treatment of advanced disease. Twenty-nine patients will be enrolled. Patients may have either measurable disease or non-measurable disease.
Patients will receive CP-675,206 at 15 mg/kg administered intravenously on day 1 of every 90-day cycle for up to 4 cycles or until disease progression or intolerance of toxicity. Each cycle is defined as a 90 +/- 4 days period. Patients should be weighed within 10 days prior to each cycle and the administered dose of CP-675,206 should be recalculated.
Patients who complete 4 doses of CP-675,206 without disease progression and who subsequently experience disease progression more than 3 months after the last dose may receive 4 additional doses of CP-675,206 provided that they have not received other systemic therapy for their melanoma. Patients with clinical benefit may be considered for additional dosing if evidence emerges supporting ongoing maintenance therapy.
Tumor assessments will be done every 3 months. All patients with objective tumor response must have additional scans scheduled 4-6 weeks after the criteria for response are first met in order to confirm the response. Additional scans will be done if clinically indicated. Survival will be monitored on all patients for up to 5 years from the date of first dose of CP-675,206. The follow up time may be adjusted based on ongoing studies using CP-675,206 for melanoma.
An exploratory study will be conducted to identify micro environmental features in the tumor that are permissive of tumor immunity (i.e: those associated with a "response" to anti-CTLA4) and to assess whether anti-CTLA4 causes peripheral mobilization of immunomodulatory inflammatory cells.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Alberta
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Calgary, Alberta, Canadá, T2N4N2
- Tom Baker Cancer Centre
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Edmonton, Alberta, Canadá, T6G 1Z2
- Cross Cancer Institute
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Ontario
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Toronto, Ontario, Canadá, M5G 2M9
- Princess Margaret Hospital
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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 uveal melanoma including choroidal melanoma, iris melanoma, and ciliary body melanoma
- Patients may either have measurable disease or non-measurable disease.
- Biopsies from a readily accessible site of disease on study enrollment are mandatory in principle. Waivers will be granted if there are no accessible lesions. The collection of a representative block of the diagnostic tumour tissue (if available) is mandatory.
- ECOG performance status of 0 or 1
- Age 18 years or older
- Adequate bone marrow, hepatic, and renal function determined within 14 days prior to registration, defined as:
- Serum lactic acid dehydrogenase (LDH) </= 1.5 x ULN.
- Alkaline phosphatase (ALP) </= 2 x ULN.
- No weight loss >/= 10% in the proceeding 4 weeks.
- CT scan of the brain with contrast or MRI of the brain within 28 days of registration showing no evidence of brain metastases.
- Females of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to registration. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential.
- Females of childbearing potential and males who have not undergone surgical sterilization must agree to practice a form of effective contraception prior to entry into the study and for 12 months following the last dose of study drug. The definition of effective contraception will be based on the judgment of the investigator.
Exclusion Criteria:
- Melanoma of cutaneous, mucosal or conjunctival origin.
- History of brain or leptomeningeal metastases.
- Received any prior CTLA4 inhibiting agent (eg MDX-010, ipilimumab) or other immunotherapy.
- History of chronic inflammatory or autoimmune disease
- History of uveitis or melanoma-associated retinopathy.
- History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any origin.
- History of hepatitis due to Hepatitis B virus or Hepatitis C virus
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: Open Label CP-675,206
Patients will receive CP-675,206 at 15 mg/kg administered intravenously on day 1 of every 90-day cycle for up to 4 cycles or until disease progression or intolerance of toxicity.
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Patients will receive CP-675,206 at 15 mg/kg administered intravenously on day 1 of ever 90 cycle for up to 4 cycles or until progression or intolerance of toxicity.
Tumor assessments will be done ever 3 months.
Additional scans will be done if clinically indicated.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Progression-free survival at 6 months after initiation of CP-675,206
Prazo: 6 months
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A 6-month progression free survivor will be defined as a patient who is alive and who has not progressed at 6 months or more post treatment.
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6 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Objective tumor response
Prazo: overall
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Duration of Objective response (CR or PR) for responding patients will be measured from the date of registration to the date of progression or death due to progressive disease, whichever occurs first.
In addition, the Duration of Complete Response will be measured from the date that a CR was first documented to the date of progression or death due to progressive disease, whichever occurs first.
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overall
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Durable response
Prazo: 6 or more months
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Durable response is defined as an objective tumor response that last 6 or more months
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6 or more months
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Median survival and overall survival
Prazo: overall
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• Overall Survival (OS) is defined as the time from the date of registration to date of death by any cause.
In the absence of confirmation of death, survival time will be censored at the last date the patient was known to be alive.
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overall
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Adverse events and tolerability
Prazo: overall
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Following the first dose, adverse events should be continuously assessed and documented during the study reporting period.
Adverse events will be followed up to and including the End of Treatment visit.
Additionally, all adverse events with a causal relationship to the study drug must be followed until the event and its sequalae have resolved, returned to baseline, been deemed irreversible, or until the patient dies.
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overall
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Rietschel P, Panageas KS, Hanlon C, Patel A, Abramson DH, Chapman PB. Variates of survival in metastatic uveal melanoma. J Clin Oncol. 2005 Nov 1;23(31):8076-80. doi: 10.1200/JCO.2005.02.6534.
- Bedikian AY, Legha SS, Mavligit G, Carrasco CH, Khorana S, Plager C, Papadopoulos N, Benjamin RS. Treatment of uveal melanoma metastatic to the liver: a review of the M. D. Anderson Cancer Center experience and prognostic factors. Cancer. 1995 Nov 1;76(9):1665-70. doi: 10.1002/1097-0142(19951101)76:93.0.co;2-j.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 Tipo Histológico
- Neoplasias
- Neoplasias por local
- Doenças oculares
- Tumores Neuroectodérmicos
- Neoplasias, Células Germinativas e Embrionárias
- Neoplasias, Tecido Nervoso
- Doenças uveais
- Tumores Neuroendócrinos
- Nevos e Melanomas
- Neoplasias oculares
- Melanoma
- Neoplasias Uveais
- Agentes Antineoplásicos
- Tremelimumabe
Outros números de identificação do estudo
- TBCC 905001
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 .
Ensaios clínicos em Melanoma Uveal
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)RescindidoMelanoma de íris | Melanoma uveal posterior de tamanho médio/grande | Melanoma Uveal Estágio IIA | Melanoma Uveal Estágio IIB | Melanoma uveal estágio IIIA | Melanoma uveal estágio IIIB | Melanoma Uveal Estágio IIICEstados Unidos
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Alliance for Clinical Trials in OncologyRetiradoMelanoma Uveal Metastático | Melanoma Uveal Avançado | Melanoma uveal irressecável
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National Cancer Institute (NCI)ExelisisConcluídoEstágio IV Melanoma Uveal AJCC v7 | Melanoma uveal recorrente | Melanoma Uveal Estágio III AJCC v7 | Melanoma uveal estágio IIIA AJCC v7 | Estágio IIIB Melanoma Uveal AJCC v7 | Estágio IIIC Melanoma Uveal AJCC v7Estados Unidos, Canadá
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Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)RescindidoMelanoma Uveal Estágio IV | Melanoma uveal estágio IIIA | Melanoma uveal estágio IIIB | Melanoma Uveal Estágio IIICEstados Unidos
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National Cancer Institute (NCI)ConcluídoMelanoma de íris | Melanoma Uveal Estágio IV | Melanoma uveal posterior de tamanho médio/grande | Melanoma uveal recorrente | Melanoma ocular com extensão extraocular | Melanoma uveal posterior de tamanho pequenoEstados Unidos, Canadá
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National Cancer Institute (NCI)ConcluídoMelanoma Cutâneo Estágio IV AJCC v6 e v7 | Melanoma recorrente | Melanoma Cutâneo Estágio IIIC AJCC v7 | Melanoma Mucoso | Melanoma de íris | Melanoma Cutâneo Estágio IIIA AJCC v7 | Melanoma Cutâneo Estágio IIIB AJCC v7 | Estágio IV Melanoma Uveal AJCC v7 | Melanoma uveal posterior de tamanho médio/grande e outras condiçõesEstados Unidos
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National Cancer Institute (NCI)Memorial Sloan Kettering Cancer Center; Institut Curie Paris; Moffitt Cancer Center...Ativo, não recrutandoMelanoma Uveal Metastático | Estágio IV Melanoma Uveal AJCC v7Estados Unidos
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National Cancer Institute (NCI)ConcluídoEstágio IV Melanoma Uveal AJCC v7 | Melanoma uveal recorrenteEstados Unidos
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National Cancer Institute (NCI)ConcluídoEstágio IV Melanoma Uveal AJCC v7 | Melanoma uveal recorrenteEstados Unidos, França, Reino Unido
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Hasumi International Research FoundationAtivo, não recrutandoMelanoma Uveal MetastáticoAlemanha
Ensaios clínicos em CP-675,206
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Catherine ShuRetiradoCâncer de Pulmão de Células Não PequenasEstados Unidos
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)ConcluídoCarcinoma de Células Renais de Células Claras | Câncer de Células Renais Metastático | Câncer de Células Renais Estágio IV AJCC v7Estados Unidos
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Abramson Cancer Center of the University of PennsylvaniaConcluídoMelanoma recorrente | Melanoma Estágio IVEstados Unidos
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Emory UniversityAstraZenecaConcluídoCarcinoma Pulmonar Recorrente de Pequenas CélulasEstados Unidos
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Northwestern UniversityNational Cancer Institute (NCI); MedImmune LLC; Avon Breast Cancer FoundationConcluídoCâncer de Mama Estágio IV | Carcinoma de mama recorrente | Receptor de estrogênio negativo | Receptor de Estrogênio Positivo | HER2/Neu NegativoEstados Unidos
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University of Wisconsin, MadisonPfizerRescindidoCâncer de próstataEstados Unidos
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)ConcluídoCarcinoma de Próstata Resistente à Castração | Adenocarcinoma de próstata | Câncer de Próstata Estágio IV AJCC v8 | Neoplasia Maligna Metastática no Osso | Câncer de Próstata Estágio IVA AJCC v8 | Câncer de Próstata Estágio IVB AJCC v8Estados Unidos
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M.D. Anderson Cancer CenterRecrutamentoCarcinoma de trompas de falópio recorrente | Carcinoma ovariano recorrente | Carcinoma Peritoneal Primário Recorrente | Carcinoma de tuba uterina resistente à platina | Carcinoma Peritoneal Primário Resistente à Platina | Carcinoma de Ovário Resistente à Platina | Carcinoma ovariano refratário | Carcinoma... e outras condiçõesEstados Unidos
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Ahmad TarhiniPfizerConcluído
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AstraZenecaConcluído