KEYNOTE-676: Phase III study of BCG and pembrolizumab for persistent/recurrent high-risk NMIBC-Reference-Cited by-同舟云学术

KEYNOTE-676: Phase III study of BCG and pembrolizumab for persistent/recurrent high-risk NMIBC

Published:2020-04 Issue:10 Volume:16 Page:507-516
ISSN:1479-6694
Container-title:Future Oncology
language:en
Short-container-title:Future Oncology

Author:

Kamat Ashish M¹,Shore Neal²,Hahn Noah³,Alanee Shaheen⁴,Nishiyama Hiroyuki⁵,Shariat Shahrokh⁶,Nam Kijoeng⁷,Kapadia Ekta⁸,Frenkl Tara⁸,Steinberg Gary⁹

Affiliation:

1. Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA

2. Department of Urology, Carolina Urologic Research Center, Myrtle Beach, SC 29572, USA

3. Department of Oncology & Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA

4. Department of Urology, Henry Ford Hospital, Detroit, MI 48202, USA

5. Department of Urology, University of Tsukuba, Tsukuba 305-8577, Japan

6. Department of Urology, Medical University of Vienna, 1090 Vienna, Austria

7. Department of Biostatistics and Research Decision Sciences, Merck & Co., Inc., Kenilworth, NJ 07033, USA

8. Department of Oncology, Merck & Co., Inc., Kenilworth, NJ 07033, USA

9. Department of Urology, NYU Langone Health, New York, NY 10017, USA

Abstract

Background: Nonmuscle-invasive bladder cancer (NMIBC) is the most common form of bladder cancer, with high rates of disease recurrence and progression. Current treatment for high-risk NMIBC involves Bacillus Calmette-Guérin (BCG) therapy, but treatment options are limited for patients with recurrent or BCG-unresponsive disease. Aberrant programmed death 1 signaling has been implicated in BCG resistance and bladder cancer recurrence and progression, and pembrolizumab has shown efficacy in patients with BCG-unresponsive high-risk NMIBC. Aim: To describe the rationale and design for the randomized, comparator-controlled Phase III KEYNOTE-676 study, which will evaluate the efficacy and safety of pembrolizumab in combination with BCG in patients with persistent/recurrent high-risk NMIBC after BCG induction therapy. Trial registration number: NCT03711032

Publisher

Future Medicine Ltd

Subject

Cancer Research,Oncology,General Medicine

Link

https://www.futuremedicine.com/doi/pdf/10.2217/fon-2019-0817

Reference51 articles.

1. National Cancer Institute. SEER cancer stat facts: bladder cancer (2019). https://seer.cancer.gov/statfacts/html/urinb.html

2. Stage, grade and pathological characteristics of bladder cancer in the UK: British Association of Urological Surgeons (BAUS) Urological Tumour Registry

3. EAU Guidelines on Non–Muscle-invasive Urothelial Carcinoma of the Bladder: Update 2016

4. Bladder cancer: diagnosis and management of bladder cancer

5. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline

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