Conference
A phase 2 multicohort study (LEAP-005) of lenvatinib plus pembrolizumab in patients with previously treated selected solid tumors: Pancreatic cancer cohort
العنوان: | A phase 2 multicohort study (LEAP-005) of lenvatinib plus pembrolizumab in patients with previously treated selected solid tumors: Pancreatic cancer cohort |
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المؤلفون: | Chung, H., Villanueva, L., Graham, Donna, Saada-Bouzid, E., Ghori, R., Kubiak, P., Gumuscu, B., Lerman, N, Gomez-Roca, C. |
المساهمون: | Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center,Yonsei University College of Medicine, Seoul, South Korea |
سنة النشر: | 2021 |
المجموعة: | The Christie School of Oncology: Christie Research Publications Repository |
الوصف: | Background:Over the past few decades, the global incidence and mortality ratesassociated with pancreatic cancer have continued to increase. Pancreatic cancer has aparticularly poor prognosis, with a 5-year survival rate of only approximately 5%. Patientswith pancreatic cancer generally respond poorly to chemotherapy, and their treatmentoptions in the second-line or later setting are limited. In two multicohort, open-labeltrials, including the phase 1b/2 KEYNOTE-146 (NCT02501096) and phase 2 LEAP-005(NCT03797326) studies, the combination of theantiangiogenic multikinase inhibitorlenvatinib and the anti‒PD-1 monoclonal antibody pembrolizumab demonstratedpromising antitumor activity with a manageable safety profile in patients with previouslytreated (both studies) and untreated (KEYNOTE-146) histologically or cytologicallyconfirmed metastatic (both studies) and/or unresectable (LEAP-005) solid tumors. In theLEAP-005 trial, benefit was seen in cohorts with glioblastoma multiforme and biliary tractcancer (second-line treatment), triple-negative breast cancer (second- and third-linetreatment), gastric and colorectal cancer (third-line treatment), and ovarian cancer(fourth-line treatment). Based on these encouraging results and the unmet need forpatients with pancreatic cancer, the LEAP-005 protocol was amended to include apancreatic cancer cohort. Here we describe the LEAP-005 trial design for this cohort.Trial design:Eligible patients are aged 18 years with histologically or cytologicallyconfirmed metastatic pancreatic ductal adenocarcinoma and have received 1 or 2prior lines of therapy (including 1 platinum- or gemcitabine-containing regimen),have measurable disease per RECIST version 1.1, have ECOG performance status of0 or 1, and provide a tissue sample for evaluation of PD-L1 expression. Patientsreceive lenvatinib 20 mg once daily plus pembrolizumab 200 mg Q3W for up to 35cycles of pembrolizumab (approximately 2 years) or until confirmed disease pro-gression, unacceptable toxicity, or withdrawal of consent. ... |
نوع الوثيقة: | conference object |
اللغة: | English |
Relation: | https://dx.doi.org/10.1016/j.annonc.2021.05.194; Chung H, Villanueva L, Graham D, Saada-Bouzid E, Ghori R, Kubiak P, et al. P-139 A phase 2 multicohort study (LEAP-005) of lenvatinib plus pembrolizumab in patients with previously treated selected solid tumors: Pancreatic cancer cohort. Annals of Oncology. 2021 Jul;32:S146.; http://hdl.handle.net/10541/624429; Annals of Oncology |
DOI: | 10.1016/j.annonc.2021.05.194 |
الاتاحة: | http://hdl.handle.net/10541/624429 https://doi.org/10.1016/j.annonc.2021.05.194 |
رقم الانضمام: | edsbas.2634B138 |
قاعدة البيانات: | BASE |
DOI: | 10.1016/j.annonc.2021.05.194 |
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