دورية أكاديمية
Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial.
| العنوان: | Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial. |
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| المؤلفون: | El-Khoueiry, Anthony B, Sangro, Bruno, Yau, Thomas, Crocenzi, Todd S, Kudo, Masatoshi, Hsu, Chiun, Kim, Tae-You, Choo, Su-Pin, Trojan, Jörg, Welling, Theodore H, Meyer, Tim, Kang, Yoon-Koo, Yeo, Winnie, Chopra, Akhil, Anderson, Jeffrey, Dela Cruz, Christine, Lang, Lixin, Neely, Jaclyn, Tang, Hao, Dastani, Homa B, Melero, Ignacio |
| المصدر: | Articles, Abstracts, and Reports |
| بيانات النشر: | Providence St. Joseph Health Digital Commons |
| سنة النشر: | 2017 |
| المجموعة: | Providence St. Joseph Health Digital Commons |
| مصطلحات موضوعية: | Aged, Antibodies, Monoclonal, Antineoplastic Agents, B7-H1 Antigen, Biomarkers, Tumor, Carcinoma, Hepatocellular, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Humans, Liver Neoplasms, Male, Response Evaluation Criteria in Solid Tumors, Time Factors, Treatment Outcome, Tumor Burden, Oncology |
| الوصف: | BACKGROUND: For patients with advanced hepatocellular carcinoma, sorafenib is the only approved drug worldwide, and outcomes remain poor. We aimed to assess the safety and efficacy of nivolumab, a programmed cell death protein-1 (PD-1) immune checkpoint inhibitor, in patients with advanced hepatocellular carcinoma with or without chronic viral hepatitis. METHODS: We did a phase 1/2, open-label, non-comparative, dose escalation and expansion trial (CheckMate 040) of nivolumab in adults (≥18 years) with histologically confirmed advanced hepatocellular carcinoma with or without hepatitis C or B (HCV or HBV) infection. Previous sorafenib treatment was allowed. A dose-escalation phase was conducted at seven hospitals or academic centres in four countries or territories (USA, Spain, Hong Kong, and Singapore) and a dose-expansion phase was conducted at an additional 39 sites in 11 countries (Canada, UK, Germany, Italy, Japan, South Korea, Taiwan). At screening, eligible patients had Child-Pugh scores of 7 or less (Child-Pugh A or B7) for the dose-escalation phase and 6 or less (Child-Pugh A) for the dose-expansion phase, and an Eastern Cooperative Oncology Group performance status of 1 or less. Patients with HBV infection had to be receiving effective antiviral therapy (viral load/mL); antiviral therapy was not required for patients with HCV infection. We excluded patients previously treated with an agent targeting T-cell costimulation or checkpoint pathways. Patients received intravenous nivolumab 0·1-10 mg/kg every 2 weeks in the dose-escalation phase (3+3 design). Nivolumab 3 mg/kg was given every 2 weeks in the dose-expansion phase to patients in four cohorts: sorafenib untreated or intolerant without viral hepatitis, sorafenib progressor without viral hepatitis, HCV infected, and HBV infected. Primary endpoints were safety and tolerability for the escalation phase and objective response rate (Response Evaluation Criteria In Solid Tumors version 1.1) for the expansion phase. This study is registered with ... |
| نوع الوثيقة: | text |
| اللغة: | unknown |
| العلاقة: | https://digitalcommons.psjhealth.org/publications/755Test; https://www.ncbi.nlm.nih.gov/pubmed/28434648Test |
| الإتاحة: | https://digitalcommons.psjhealth.org/publications/755Test https://www.ncbi.nlm.nih.gov/pubmed/28434648Test |
| رقم الانضمام: | edsbas.89622B4A |
| قاعدة البيانات: | BASE |
| الوصف غير متاح. |