Safety and Tolerability of TAR-200 and Nivolumab in Subjects With Muscle-Invasive Bladder Cancer

Bladder Cancer TNM Staging Distant Metastasis (M) M0 Clinical Trial

Official title: A Multicenter Study of TAR-200 in Combination With Nivolumab (OPDIVO) in Subjects With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Scheduled for Radical Cystectomy and Are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy

Status Terminated

Clinical Trial Summary

The purpose of this study is to determine if TAR-200, an investigational drug delivery system, in combination with nivolumab is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) who are scheduled for radical cystectomy (RC) during an 84-day dosing cycle induction period comprised of four consecutive 21-day dosing cycles.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Bladder Cancer TNM Staging Distant Metastasis (M) M0
• Bladder Cancer TNM Staging Primary Tumor (T) T2
• Bladder Cancer TNM Staging Primary Tumor (T) T2A
• Bladder Cancer TNM Staging Primary Tumor (T) T2B
• Bladder Cancer TNM Staging Primary Tumor (T) T3
• Bladder Cancer TNM Staging Primary Tumor (T) T3A
• Bladder Cancer TNM Staging Primary Tumor (T) T3B
• Bladder Cancer TNM Staging Regional Lymph Node (N) N0
• Bladder Cancer TNM Staging Regional Lymph Node (N) N1
• Neoplasms
• Urinary Bladder Neoplasms

• NCT number: NCT03518320
• Study type: Interventional
• Source: Taris Biomedical LLC
• Status: Terminated
• Phase: Phase 1
• Start date: January 2, 2019
• Completion date: December 11, 2019