NCT03319745

Pembrolizumab in Treating Patients With Bladder Cancer Undergoing Radical Cystectomy

A Window of Opportunity Phase II Study of Pembrolizumab in Patients With Bladder Cancer Undergoing Radical Cystectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the side effects of pembrolizumab and to see how well it works in treating patients with bladder cancer who are undergoing surgery to remove the bladder. 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.

Detailed description

PRIMARY OBJECTIVE: I. To characterize the safety profile of pembrolizumab in patients with urothelial carcinoma undergoing radical cystectomy. SECONDARY OBJECTIVES: I. To explore a signal of anti-cancer immunological activity by evaluating surgical specimens for evidence of post-treatment lymphocytic infiltration and residual tumor compared to pre-treatment biopsy samples. II. To explore a signal of biomarker activity by evaluating surgical specimens and blood samples for established and not-so-established markers of response to pembrolizumab. III. To report the tumor yield and sufficiency of tumor for immunological and biomarker activity. IV. To examine the interaction of the human microbiome and pathologic response to pembrolizumab. OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. About 4 weeks after treatment, patients then undergo radical cystectomy per standard of care. After completion of study treatment, patients are followed up to 30 and 90 days.

Conditions

• Stage I Bladder Cancer AJCC v8
• Stage II Bladder Cancer AJCC v8
• Stage III Bladder Cancer AJCC v8
• Stage IIIA Bladder Cancer AJCC v8
• Stage IIIB Bladder Cancer AJCC v8

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2018-01-11
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2017-10-24
• Last updated: 2024-06-25
• Results posted: 2024-06-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study