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)
- Sponsor:
- Bicycle Therapeutics
- Sponsor Study ID:
- BT8009-230
- 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.
- eConsent:
- Not available
- Study Documents:
-
Open Study Documents
(MUSC NetID required for document access)
For more information about this trial please contact the study team:
-
Medical University of South Carolina
- Principal Investigator, Gourdin, Theodore, at gourdith@musc.edu .
- Study Coordinator, Tucker, Renee, at tuckerr@musc.edu .
Trial opened at the following institutions:
Medical University of South Carolina