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Phase I Dose Escalation/Dose Expansion Trial of NBTXR3/SBRT in Combination with Nivolumab or Pembrolizumab for the Treatment of Anti-PD-1 Naïve or Resistant Patients with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

delete2026-04-16
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PRE
AI
C
C. Shen *
A
A. Sukari
W
W.A. Stokes
G
G.Q. Yang
N
N.F. Saba
J
J. Weiss
J
J.M. Frakes
J
J.J. Caudell
P
P. Chang
S
S. Murgu
M
M. Lohr
J
J.W. Chan
K
K. Kirtane
R
R. Gineste
D
D. Rolando
O
O.I. Vivar
Z
Z. Gooi
A
A. Juloori
T
T. Hackman
A
A.J. Rosenberg
DOI:10.1016/j.ijrobp.2026.02.184delete
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Abstract

Abstract

En 中文
Immune checkpoint inhibitors (ICIs) alone or in combination with chemotherapy are now a standard of care in recurrent/metastatic (R/M) HNSCC, but their efficacy is limited. While locoregional recurrence is the most clinically significant pattern of failure for both morbidity and mortality, distant failure also contributes meaningfully to outcomes in this patient population. As such, optimizing control of one or both addresses unmet needs. NBTXR3 is a novel radioenhancer composed of functionalized hafnium oxide nanoparticles administered by a one-time intratumoral injection which locally amplifies radiotherapy (RT). NBTXR3/RT has also demonstrated an ability to trigger local and systemic immune responses in pre-clinical models. Here we report outcomes in patients with R/M HNSCC who were either naïve to or continued ICI therapy combined with NBTRX3/RT after primary or secondary resistance to ICI alone.
Keywords:
NBTXR3
radiotherapy
immune checkpoint inhibitors
head and neck squamous cell carcinoma
pembrolizumab
nivolumab

Journal

I
International Journal of Radiation Oncology*Biology*Physics
IF:
0
Papers:
394
Citations:
0

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H
H. Lee Moffitt Cancer Center and Research Institute
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nanobiotix
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Karmanos Cancer Institute
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Emory University
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radiation oncology
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