An Open-label Single-Arm Phase 2 Study to Evaluate Enfortumab Vedotin plus Pembrolizumab for Bladder Preservation in Participants with Muscle-invasive Bladder Cancer

Brief description of study

This is a global, open-label, phase 2 study in adult participants with histologically confirmed MIBC (stage cT2–T4aN0M0 or T1-T4aN1M0) who are eligible for RC and who have not received prior systemic therapy or radiotherapy for MIBC. Participants may be eligible or ineligible for cisplatin chemotherapy. Approximately 240 participants will be enrolled to have approximately 160 participants who achieve cCR after treatment with enfortumab vedotin in combination with pembrolizumab, assuming a 67% cCR rate.


Clinical Study Identifier: s26-00325
ClinicalTrials.gov Identifier: NCT07475806
Principal Investigator: Katie S. Murray.
Other Investigators: Caitlin Elizabeth Ordonez Ferri, Tiffany M Tomberlin, James S Wysock, Victor Ricardo Adorno Febles, Kenia J Rodriguez, Carol M Lee, Laura Catherine Bauer, Doris M Salazar, Jonathan B Kahn, Minas Platon Economides, William C Huang, Jiping Zeng, Wei Phin Tan, David R. Wise.


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