دورية أكاديمية
Multicenter, double-blind, placebo-controlled trial of seviprotimut-L polyvalent melanoma vaccine in patients with post-resection melanoma at high risk of recurrence
| العنوان: | Multicenter, double-blind, placebo-controlled trial of seviprotimut-L polyvalent melanoma vaccine in patients with post-resection melanoma at high risk of recurrence |
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| المؤلفون: | Slingluff, Craig L, Lewis, Karl D, Andtbacka, Robert, Hyngstrom, John, Milhem, Mohammed, Markovic, Svetomir N, Bowles, Tawnya, Hamid, Omid, Hernandez-Aya, Leonel, Claveau, Joel, Jang, Sekwon, Philips, Prejesh, Holtan, Shernan G, Shaheen, Montaser F, Curti, Brendan, Schmidt, William, Butler, Marcus O, Paramo, Juan, Lutzky, Jose, Padmanabhan, Arvinda, Thomas, Sajeve, Milton, Daniel, Pecora, Andrew, Sato, Takami, Hsueh, Eddy, Badarinath, Suprith, Keech, John, Kalmadi, Sujith, Kumar, Pallavi, Weber, Robert, Levine, Edward, Berger, Adam, Bar, Anna, Beck, J Thaddeus, Travers, Jeffrey B, Mihalcioiu, Catalin, Gastman, Brian, Beitsch, Peter, Rapisuwon, Suthee, Glaspy, John, McCarron, Edward C, Gupta, Vinay, Behl, Deepti, Blumenstein, Brent, Peterkin, Joanna J |
| المصدر: | Department of Medical Oncology Faculty Papers |
| بيانات النشر: | Jefferson Digital Commons |
| سنة النشر: | 2021 |
| المجموعة: | Jefferson Digital Commons (Thomas Jefferson University, Philadelphia) |
| مصطلحات موضوعية: | active, immunotherapy, melanoma, vaccination, Medicine and Health Sciences, Oncology |
| الوصف: | Background: Most patients with advanced melanomas relapse after checkpoint blockade therapy. Thus, immunotherapies are needed that can be applied safely early, in the adjuvant setting. Seviprotimut-L is a vaccine containing human melanoma antigens, plus alum. To assess the efficacy of seviprotimut-L, the Melanoma Antigen Vaccine Immunotherapy Study (MAVIS) was initiated as a three-part multicenter, double-blind, placebo-controlled phase III trial. Results from part B1 are reported here. Methods: Patients with AJCC V.7 stage IIB-III cutaneous melanoma after resection were randomized 2:1, with stage stratification (IIB/C, IIIA, IIIB/C), to seviprotimut-L 40 mcg or placebo. Recurrence-free survival (RFS) was the primary endpoint. For an hypothesized HR of 0.625, one-sided alpha of 0.10, and power 80%, target enrollment was 325 patients. Results: For randomized patients (n=347), arms were well-balanced, and treatment-emergent adverse events were similar for seviprotimut-L and placebo. For the primary intent-to-treat endpoint of RFS, the estimated HR was 0.881 (95% CI: 0.629 to 1.233), with stratified logrank p=0.46. However, estimated HRs were not uniform over the stage randomized strata, with HRs (95% CIs) for stages IIB/IIC, IIIA, IIIB/IIIC of 0.67 (95% CI: 0.37 to 1.19), 0.72 (95% CI: 0.35 to 1.50), and 1.19 (95% CI: 0.72 to 1.97), respectively. In the stage IIB/IIC stratum, the effect on RFS was greatest for patients <60 years old (HR=0.324 (95% CI: 0.121 to 0.864)) and those with ulcerated primary melanomas (HR=0.493 (95% CI: 0.255 to 0.952)). Conclusions: Seviprotimut-L is very well tolerated. Exploratory efficacy model estimation supports further study in stage IIB/IIC patients, especially younger patients and those with ulcerated melanomas. |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| العلاقة: | https://jdc.jefferson.edu/medoncfp/157Test; https://jdc.jefferson.edu/cgi/viewcontent.cgi?article=1157&context=medoncfpTest |
| الإتاحة: | https://jdc.jefferson.edu/medoncfp/157Test https://jdc.jefferson.edu/cgi/viewcontent.cgi?article=1157&context=medoncfpTest |
| حقوق: | http://creativecommons.org/licenses/by-nc/4.0Test/ |
| رقم الانضمام: | edsbas.88C5D124 |
| قاعدة البيانات: | BASE |
| الوصف غير متاح. |