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

Ashish M. Kamat; Neal Shore; Noah Hahn; Shaheen Alanee; Hiroyuki Nishiyama; Shahrokh Shariat; Kijoeng Nam; Ekta Kapadia; Tara Frenkl; Gary Steinberg

doi:10.2217/fon-2019-0817

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

Ashish M. Kamat, Neal Shore, Noah Hahn, Shaheen Alanee, Hiroyuki Nishiyama, Shahrokh Shariat, Kijoeng Nam, Ekta Kapadia, Tara Frenkl, Gary Steinberg

Urology

Research output: Contribution to journal › Review article › peer-review

46 Scopus citations

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. 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: NCT0371103.

Original language	English (US)
Pages (from-to)	507-516
Number of pages	10
Journal	Future Oncology
Volume	16
Issue number	10
DOIs	https://doi.org/10.2217/fon-2019-0817
State	Published - Apr 2020

Keywords

Bacillus Calmette-Guérin
bladder cancer
immunotherapy
nonmuscle-invasive bladder cancer
pembrolizumab
programmed death 1
programmed death ligand 1

ASJC Scopus subject areas

Oncology
Cancer Research

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

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-Gu{\'e}rin (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. 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: NCT0371103.",

keywords = "Bacillus Calmette-Gu{\'e}rin, bladder cancer, immunotherapy, nonmuscle-invasive bladder cancer, pembrolizumab, programmed death 1, programmed death ligand 1",

author = "Kamat, {Ashish M.} and Neal Shore and Noah Hahn and Shaheen Alanee and Hiroyuki Nishiyama and Shahrokh Shariat and Kijoeng Nam and Ekta Kapadia and Tara Frenkl and Gary Steinberg",

note = "Publisher Copyright: {\textcopyright} 2020 Merck Sharp & Dohme Corp.",

year = "2020",

month = apr,

doi = "10.2217/fon-2019-0817",

language = "English (US)",

volume = "16",

pages = "507--516",

journal = "Future Oncology",

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T2 - Phase III study of BCG and pembrolizumab for persistent/recurrent high-risk NMIBC

AU - Kamat, Ashish M.

AU - Shore, Neal

AU - Hahn, Noah

AU - Alanee, Shaheen

AU - Nishiyama, Hiroyuki

AU - Shariat, Shahrokh

AU - Nam, Kijoeng

AU - Kapadia, Ekta

AU - Frenkl, Tara

AU - Steinberg, Gary

PY - 2020/4

Y1 - 2020/4

N2 - 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. 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: NCT0371103.

AB - 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. 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: NCT0371103.

KW - Bacillus Calmette-Guérin

KW - bladder cancer

KW - immunotherapy

KW - nonmuscle-invasive bladder cancer

KW - pembrolizumab

KW - programmed death 1

KW - programmed death ligand 1

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DO - 10.2217/fon-2019-0817

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SN - 1479-6694

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ER -

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

Abstract

Keywords

ASJC Scopus subject areas

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