) in patients treated at the recommended phase 2 dose of tebentafusp.
Patients with an initial assessment of progressive disease according to RECIST v1.1 could continue therapy beyond initial progressive disease, provided that they did not have symptomatic progression requiring alternative therapy and the investigator believed they were continuing to derive clinical benefit. The modified immune-related RECIST criteriawere used to evaluate response to treatment beyond progression.
The trial was carried out in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines, and the study protocol was approved by the relevant ethics bodies at each participating site: Princess Margaret Cancer Centre, Toronto, Canada; Charite Universitaetsmedizin Berlin – Campus Benjamin Franklin, Berlin, Germany; Universitaetsklinikum Heidelberg, Heidelberg, Germany; Institut Catala d’Oncologia l’Hospitalet, Hospital Duran i Reynals, Barcelona, Spain;...
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