Overview

Pembrolizumab in MIBC

Status:
Not yet recruiting
Trial end date:
2024-02-01
Target enrollment:
Participant gender:
Summary
Subjects with cT2-T3N0M0 urothelial cancer of the bladder will be enrolled. After completing two cycles of pembrolizumab, subjects will undergo a restaging MRI of the abdomen and pelvis with a standard acquisition protocol (as outlined in the protocol) as well as CT chest. A CT of the abdomen and pelvis may be performed if there are contraindications to MRI. Patients will also undergo a restaging cystoscopy and biopsies/TURBT as outlined in the protocol. Patients achieving a clinical complete response to treatment (defined in the protocol) will proceed with "maintenance" single agent pembrolizumab followed by surveillance. All other patients will proceed with standard of care local therapy as per their treating physicians followed by "adjuvant" pembrolizumab.
Phase:
Phase 2
Details
Lead Sponsor:
Vaibhav Patel
Collaborator:
Merck Sharp & Dohme LLC
Treatments:
Pembrolizumab