KEYNOTE-361

Merck Provides Update on Phase 3 KEYNOTE-361 Trial Evaluating KEYTRUDA® (pembrolizumab) as Monotherapy and in Combination with Chemotherapy in Patients with Advanced or Metastatic Urothelial Carcinoma

Retrieved on: 
Tuesday, June 9, 2020

KEYNOTE-361 (ClinicalTrials.gov, NCT02853305 ) is a randomized, open-label, Phase 3 trial evaluating KEYTRUDA as monotherapy and in combination with chemotherapy versus chemotherapy alone, the current standard of care, for the first-line treatment of advanced or metastatic urothelial carcinoma.

Key Points: 
  • KEYNOTE-361 (ClinicalTrials.gov, NCT02853305 ) is a randomized, open-label, Phase 3 trial evaluating KEYTRUDA as monotherapy and in combination with chemotherapy versus chemotherapy alone, the current standard of care, for the first-line treatment of advanced or metastatic urothelial carcinoma.
  • KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
  • KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
  • In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma.