دورية أكاديمية
2568 Pembrolizumab for patients with leptomeningeal disease from advanced solid tumors
| العنوان: | 2568 Pembrolizumab for patients with leptomeningeal disease from advanced solid tumors |
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| المؤلفون: | Naidoo, Jarushka, Hu, Chen, Schrek, Karisa, Connolly, Roisin, Santa-Maria, Cesar, Lipson, Evan, Mehra, Ranee, Bettegowda, Redmond, Kristin, Venkatesan, Arun, Grossman, Stuart |
| المصدر: | Journal of Clinical and Translational Science ; volume 2, issue S1, page 44-45 ; ISSN 2059-8661 |
| بيانات النشر: | Cambridge University Press (CUP) |
| سنة النشر: | 2018 |
| مصطلحات موضوعية: | General Medicine |
| الوصف: | OBJECTIVES/SPECIFIC AIMS: Pembrolizumab is an anti-PD-1 immune checkpoint antibody that has demonstrated promising anti-tumor activity in patients with solid tumor malignancies, including patients with brain metastases from malignant melanoma and non-small cell lung cancer. Leptomeningeal disease (LMD) is a rare form of malignant spread to the central nervous system (CNS), that occurs in 2%–10% of patients with solid tumors, most commonly in breast cancer and non-small cell lung cancer. We propose an open-label phase II study of pembrolizumab in patients with LMD from advanced solid tumors (NCT03091478). This study aims to determine if pembrolizumab therapy can lead to a radiologic, cytologic or clinical response in the CNS, in patients with LMD. METHODS/STUDY POPULATION: Patients with pathologically confirmed advanced solid tumors, and either radiologic or cytologic evidence of LMD, will be identified at a single institution. Radiologic LMD will be defined as a >4 mm area of measurable LMD on gadolinium-enhanced MRI brain/total-spine; and cytologic LMD will be defined as the presence of malignant cells on CSF cytology. Patients will be excluded if they have: active autoimmune conditions that require immunosuppression, received radiation therapy to the only area of measurable LMD within 3 months of study enrollment, have an ECOG performance status <1. Once enrolled, patients will receive pembrolizumab 200 mg intravenously every 3-weeks, until disease progression or unacceptable toxicity. Patients will have CSF sample sampling, blood draws, radiologic imaging of the body (CT), brain/total-spine (gadolinium-enhanced MRI) pre-treatment, after 2 and after 4 cycles of therapy, for response assessment and correlative studies. The primary endpoint of the study is CNS response assessed at 12 weeks/after 4 cycles of pembrolizumab, defined either as radiologic response (reduction in size of LMD on gadolinium-enhanced MRI) and/or cytologic response (conversion of positive to negative CSF cytology on 2 consecutive ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1017/cts.2018.174 |
| الإتاحة: | https://doi.org/10.1017/cts.2018.174Test https://www.cambridge.org/core/services/aop-cambridge-core/content/view/S2059866118001747Test |
| حقوق: | http://creativecommons.org/licenses/by/4.0Test/ |
| رقم الانضمام: | edsbas.6D304A2B |
| قاعدة البيانات: | BASE |
| DOI: | 10.1017/cts.2018.174 |
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