NCT04383743

Pembrolizumab and Combination Chemotherapy Before Surgery for the Treatment of Muscle-Invasive Bladder Cancer

Pembrolizumab and aMVAC Chemotherapy as Neoadjuvant Therapy in Non-Urothelial Histology Muscle-Invasive Bladder Cancer: A Pilot Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot study is evaluating how well pembrolizumab and combination chemotherapy before surgery work for the treatment of specific types of muscle-invasive bladder cancer that have unusual appearance (variants). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, vinblastine, adriamycin, and cisplatin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab and combination chemotherapy before surgery may work better in treating patients with these muscle invasive bladder cancer variants compared to chemotherapy alone.

Detailed description

OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 of weeks 0, 3, and 6 and methotrexate IV, vinblastine IV, doxorubicin IV, and cisplatin IV on day 1 of weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. Patients also receive pegfilgrastim subcutaneously (SC) on day 1 or 2 of weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care radical cystectomy. After completion of study treatment, patients are followed up about 1 month after surgery and then every 3-6 months for 2 years.

Conditions

• Stage II Bladder Cancer AJCC v8
• Stage IIIA Bladder Cancer AJCC v8
• Muscle Invasive Bladder Carcinoma

Interventions

Type	Name	Description
DRUG	Cisplatin	Given IV
DRUG	Doxorubicin	Given IV
DRUG	Methotrexate	Given IV
BIOLOGICAL	Pegfilgrastim	Given SC
BIOLOGICAL	Pembrolizumab	Given IV
PROCEDURE	Radical Cystectomy	Undergo standard of care radical cystectomy
DRUG	Vinblastine Sulfate	Given IV

Timeline

• Start date: 2020-11-24
• Primary completion: 2024-06-17
• Completion: 2025-03-04
• First posted: 2020-05-12
• Last updated: 2025-09-18
• Results posted: 2025-09-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study