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NCT05406713 · ClinicalTrials.gov record · last posted 2026-04-08

Pembrolizumab in Muscle-invasive Bladder Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started2022-07-13
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Amendment record 19 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 19 times since 2022-06-03; most recent amendment 2026-04-02. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2025-02-14
Status change RecruitingActive, Not Recruitingv17
2022-08-29
Status change Not Yet RecruitingRecruitingv2
Trial Details
NCT Number NCT05406713
Lead Sponsor Matthew Galsky
Collaborators: Merck Sharp & Dohme LLC
Conditions Muscle Invasive Bladder Carcinoma, Localized Cancer, Urothelial Carcinoma
Enrollment 46 participants
Start Date 2022-07-13
Primary Completion 2027-01-31 (estimated)
Study Completion 2028-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-08