Autor: |
Christine D. Palmer, Amy R. Rappaport, Matthew J. Davis, Meghan G. Hart, Ciaran D. Scallan, Sue-Jean Hong, Leonid Gitlin, Lauren D. Kraemer, Sonia Kounlavouth, Aaron Yang, Lindsey Smith, Desiree Schenk, Mojca Skoberne, Kiara Taquechel, Martina Marrali, Jason R. Jaroslavsky, Charmaine N. Nganje, Elizabeth Maloney, Rita Zhou, Daniel Navarro-Gomez, Adrienne C. Greene, Gijsbert Grotenbreg, Renee Greer, Wade Blair, Minh Duc Cao, Shawn Chan, Kyounghwa Bae, Alexander I. Spira, Sameek Roychowdhury, David P. Carbone, Brian S. Henick, Charles G. Drake, Benjamin J. Solomon, Daniel H. Ahn, Amit Mahipal, Steve B. Maron, Benny Johnson, Raphael Rousseau, Roman Yelensky, Chih-Yi Liao, Daniel V. T. Catenacci, Andrew Allen, Andrew R. Ferguson, Karin Jooss |
Rok vydání: |
2022 |
Předmět: |
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Zdroj: |
Nature medicine. 28(8) |
ISSN: |
1546-170X |
Popis: |
Checkpoint inhibitor (CPI) therapies provide limited benefit to patients with tumors of low immune reactivity. T cell-inducing vaccines hold promise to exert long-lasting disease control in combination with CPI therapy. Safety, tolerability and recommended phase 2 dose (RP2D) of an individualized, heterologous chimpanzee adenovirus (ChAd68) and self-amplifying mRNA (samRNA)-based neoantigen vaccine in combination with nivolumab and ipilimumab were assessed as primary endpoints in an ongoing phase 1/2 study in patients with advanced metastatic solid tumors (NCT03639714). The individualized vaccine regimen was safe and well tolerated, with no dose-limiting toxicities. Treatment-related adverse events (TRAEs)10% included pyrexia, fatigue, musculoskeletal and injection site pain and diarrhea. Serious TRAEs included one count each of pyrexia, duodenitis, increased transaminases and hyperthyroidism. The RP2D was 10 |
Databáze: |
OpenAIRE |
Externí odkaz: |
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