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Published in: Current Urology Reports 12/2018

01-12-2018 | Urothelial Cancer (S Daneshmand, Section Editor)

Current Clinical Trials in Non-muscle Invasive Bladder Cancer

Authors: Timo K. Nykopp, Jose Batista da Costa, Miles Mannas, Peter C. Black

Published in: Current Urology Reports | Issue 12/2018

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Abstract

Purpose of Review

As our molecular understanding of bladder cancer continues to advance, more and more novel agents are entering clinical trials across the spectrum of bladder cancer stages. The clinical trial activity for non-muscle invasive bladder cancer (NMIBC) has been boosted further by the evolution of specific disease states that set more uniform inclusion criteria for clinical trial design. Here, we aimed to review the current clinical trials landscape in non-muscle invasive bladder cancer with respect to these disease states.

Recent Findings

Most active clinical trials focus on high-risk NMIBC in either the BCG-naïve or BCG-unresponsive setting. Strict criteria to define the disease state and a clear pathway to drug registration have encouraged trials for patients with BCG-unresponsive NMIBC. The most promising potential breakthroughs for BCG-naïve patients include alternative BCG strains, immune-priming with intradermal BCG vaccination, and systemic immune checkpoint blockade. The latter therapy is also being actively investigated in multiple trials in BCG-unresponsive NMIBC, along with novel viral agents such as INSTILADRIN (nadofaragene firadenovec) and targeted agents such as oportuzumab monatox.

Summary

After many years of relative stagnation, multiple new therapies currently under investigation in well-designed clinical trials appear poised for routine clinical implementation in the near future. These therapies should dramatically improve the outcome of patients with NMIBC. We can look forward to the challenges of biomarker-driven drug selection, optimal drug sequencing, and rational combination therapies.
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Metadata
Title
Current Clinical Trials in Non-muscle Invasive Bladder Cancer
Authors
Timo K. Nykopp
Jose Batista da Costa
Miles Mannas
Peter C. Black
Publication date
01-12-2018
Publisher
Springer US
Published in
Current Urology Reports / Issue 12/2018
Print ISSN: 1527-2737
Electronic ISSN: 1534-6285
DOI
https://doi.org/10.1007/s11934-018-0852-6

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