Background:Adjuvant pembrolizumab therapy after surgery for renal-cell carcinoma was approved on the basis of a significant improvement in disease-free survival in the KEYNOTE-564 trial.Whether the results regarding o...Background:Adjuvant pembrolizumab therapy after surgery for renal-cell carcinoma was approved on the basis of a significant improvement in disease-free survival in the KEYNOTE-564 trial.Whether the results regarding overall survival from the third prespecified interim analysis of the trial would also favor pembrolizumab was uncertain.Methods:In this phase 3,double-blind,placebo-controlled trial,we randomly assigned(in a 1:1 ratio)participants with clear-cell renal-cell carcinoma who had an increased risk of recurrence after surgery to receive pembrolizumab(at a dose of 200 mg)or placebo every 3 weeks for up to 17 cycles(approximately 1 year)or until recurrence,the occurrence of unacceptable toxic effects,or withdrawal of consent.A significant improvement in disease-free survival according to investigator assessment(the primary end point)was shown previously.Overall survival was the key secondary end point.Safety was a secondary end point.展开更多
文摘Background:Adjuvant pembrolizumab therapy after surgery for renal-cell carcinoma was approved on the basis of a significant improvement in disease-free survival in the KEYNOTE-564 trial.Whether the results regarding overall survival from the third prespecified interim analysis of the trial would also favor pembrolizumab was uncertain.Methods:In this phase 3,double-blind,placebo-controlled trial,we randomly assigned(in a 1:1 ratio)participants with clear-cell renal-cell carcinoma who had an increased risk of recurrence after surgery to receive pembrolizumab(at a dose of 200 mg)or placebo every 3 weeks for up to 17 cycles(approximately 1 year)or until recurrence,the occurrence of unacceptable toxic effects,or withdrawal of consent.A significant improvement in disease-free survival according to investigator assessment(the primary end point)was shown previously.Overall survival was the key secondary end point.Safety was a secondary end point.
