KEYNOTE-716: Phase III study of adjuvant pembrolizumab versus placebo in resected high-risk stage II melanoma
العنوان: | KEYNOTE-716: Phase III study of adjuvant pembrolizumab versus placebo in resected high-risk stage II melanoma |
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المؤلفون: | Piotr Rutkowski, Sama Ahsan, Jean-Jacques Grob, Matteo S. Carlino, James R. Anderson, Merrick I. Ross, John M. Kirkwood, Jeffrey E. Gershenwald, Caroline Robert, Jason J. Luke, Nageatte Ibrahim, Charles H. Yoon, Peter Mohr, Georgina V. Long, Alexander M.M. Eggermont, Axel Hauschild, Paolo A. Ascierto, Andrew Poklepovic, Richard A. Scolyer |
المصدر: | Future Oncology. 16:4429-4438 |
بيانات النشر: | Future Medicine Ltd, 2020. |
سنة النشر: | 2020 |
مصطلحات موضوعية: | Adult, Male, Oncology, Cancer Research, medicine.medical_specialty, Skin Neoplasms, Adolescent, medicine.medical_treatment, Dermatologic Surgical Procedures, Programmed Cell Death 1 Receptor, Pembrolizumab, Antibodies, Monoclonal, Humanized, Placebo, Disease-Free Survival, Placebos, Young Adult, 03 medical and health sciences, Antineoplastic Agents, Immunological, 0302 clinical medicine, Internal medicine, medicine, Adjuvant therapy, Humans, Multicenter Studies as Topic, 030212 general & internal medicine, Young adult, Child, Melanoma, Neoplasm Staging, Randomized Controlled Trials as Topic, Cross-Over Studies, business.industry, General Medicine, medicine.disease, Crossover study, Clinical trial, Clinical Trials, Phase III as Topic, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Female, Neoplasm Recurrence, Local, business, Adjuvant |
الوصف: | Patients with high-risk stage II melanoma are at significant risk for recurrence after surgical resection. Adjuvant treatment options to lower the risk for distant metastases are limited. Although adjuvant IFN-α2b is associated with improved relapse-free survival in patients with high-risk melanoma, toxicity and limited overall survival benefits limit its use. Adjuvant treatment with the PD-1 inhibitor pembrolizumab significantly improved recurrence-free survival, compared with placebo, in patients with resected stage III melanoma in the Phase III KEYNOTE-054 trial; efficacy in patients with stage II disease has not been established. This article describes the design and rationale of KEYNOTE-716 (NCT03553836), a two-part, randomized, placebo-controlled, multicenter Phase III study of adjuvant pembrolizumab in patients with surgically resected high-risk stage II melanoma. Clinical trial registry & ID: ClinicalTrials.gov, NCT03553836 |
تدمد: | 1744-8301 1479-6694 |
الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d6a00dd1a28f82ed3c8216b416ba2d53Test https://doi.org/10.2217/fon-2019-0666Test |
حقوق: | OPEN |
رقم الانضمام: | edsair.doi.dedup.....d6a00dd1a28f82ed3c8216b416ba2d53 |
قاعدة البيانات: | OpenAIRE |
تدمد: | 17448301 14796694 |
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