NCT02581982

Paclitaxel and Pembrolizumab in Treating Patients With Refractory Metastatic Urothelial Cancer

Single-Arm Phase II Combination Study of Low-Dose Paclitaxel With Pembrolizumab in Platinum-Refractory Urothelial Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well paclitaxel and pembrolizumab works in treating patients with urothelial cancer that has not responded to previous treatment and has spread to other places in the body. Drugs used in chemotherapy, such as paclitaxel, 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. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving paclitaxel together with pembrolizumab may be an effective treatment for urothelial cancer.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the overall response rate (ORR) of pembrolizumab combined with paclitaxel. SECONDARY OBJECTIVES: I. To determine the safety and tolerability of pembrolizumab combined with paclitaxel. II. To calculate the progression-free survival (PFS) rate at 6 months. TERTIARY OBJECTIVES: I. To determine the immune effects of pembrolizumab combined with paclitaxel. II. To associate immune effects with tumor response. III. To explore changes in immune-regulatory micro ribonucleic acids (RNAs) as biomarkers of response. OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and paclitaxel IV over 60 minutes on day 1 and 8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up within 30 days and then every 3 months for 1 year.

Conditions

• Transitional Cell Carcinoma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Paclitaxel	Given IV
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2016-04-06
• Primary completion: 2021-05-11
• Completion: 2022-12-19
• First posted: 2015-10-21
• Last updated: 2023-01-10
• Results posted: 2022-10-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study