NCT05406713

Pembrolizumab in Muscle-invasive Bladder Cancer

Neoadjuvant Pembrolizumab in Patients With Muscle-invasive Bladder Cancer With Selective Bladder Sparing

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Matthew Galsky · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Muscle Invasive Bladder Carcinoma
• Localized Cancer
• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	400 mg intravenously

Timeline

• Start date: 2022-07-13
• Primary completion: 2027-01-31
• Completion: 2028-01-31
• First posted: 2022-06-06
• Last updated: 2026-04-08

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study