Sponsor: Bicycle Therapeutics
Sponsor Study ID: BT8009-230
Study Title: A Randomized Open-Label Phase 2/3 Study of BT8009 as Monotherapy or in Combination in Participants with Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)
CTO #: 103864
NCT Number: NCT06225596
Phase: II
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Bladder
Study Objectives: To evaluate the efficacy of BT8009 in combination with pembrolizumab, measured by progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) assessed by blinded independent central review (BICR). To assess clinical activity by the objective response rate (ORR) per RECIST v1.1 assessed by BICR and by the Investigator.