作者
Antoni Ribas, Igor Puzanov, Reinhard Dummer, Dirk Schadendorf, Omid Hamid, Caroline Robert, F Stephen Hodi, Jacob Schachter, Anna C Pavlick, Karl D Lewis, Lee D Cranmer, Christian U Blank, Steven J O'Day, Paolo A Ascierto, April KS Salama, Kim A Margolin, Carmen Loquai, Thomas K Eigentler, Tara C Gangadhar, Matteo S Carlino, Sanjiv S Agarwala, Stergios J Moschos, Jeffrey A Sosman, Simone M Goldinger, Ronnie Shapira-Frommer, Rene Gonzalez, John M Kirkwood, Jedd D Wolchok, Alexander Eggermont, Xiaoyun Nicole Li, Wei Zhou, Adriane M Zernhelt, Joy Lis, Scot Ebbinghaus, S Peter Kang, Adil Daud
发表日期
2015/8/1
期刊
The lancet oncology
卷号
16
期号
8
页码范围
908-918
出版商
Elsevier
简介
Background
Patients with melanoma that progresses on ipilimumab and, if BRAFV600 mutant-positive, a BRAF or MEK inhibitor or both, have few treatment options. We assessed the efficacy and safety of two pembrolizumab doses versus investigator-choice chemotherapy in patients with ipilimumab-refractory melanoma.
Methods
We carried out a randomised phase 2 trial of patients aged 18 years or older from 73 hospitals, clinics, and academic medical centres in 12 countries who had confirmed progressive disease within 24 weeks after two or more ipilimumab doses and, if BRAFV600 mutant-positive, previous treatment with a BRAF or MEK inhibitor or both. Patients had to have resolution of all ipilimumab-related adverse events to grade 0–1 and prednisone 10 mg/day or less for at least 2 weeks, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and at least one measurable lesion to …
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A Ribas, I Puzanov, R Dummer, D Schadendorf… - The lancet oncology, 2015