Neoplasms

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Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Head and Neck Neoplasms

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All Drugs and Chemicals

Antineoplastic Agents

Cetuximab

Antineoplastic Agents, Immunological

NBTXR3, as an intratumoral/intranodal injection, activated by investigator's choice of RT alone or RT in combination with cetuximab. NBTXR3 is given as a single intratumoral injection as a dose of 33% of the Gross Tumor Volume

Investigator's choice of RT alone or RT in combination with cetuximab

Suspension of inert, crystalline hafnium oxide particles, designed to generate oxygen free radicals to destroy cancer cells after activation by ionizing radiation.

NBTXR3

Intensity-modulated radiation therapy (IMRT): 70 Gray in 35 fractions over a 7-week period.

Radiation Therapy

Floris Andriessen

Peggy Galluzzi

Sue Yom, MD, PhD

Jimmy J Caudell, MD, PhD

Victoria Forte, MD

Colette Shen, MD, PhD

Dietmar Thurnher, MD

Martin Burian, MD

Thorsten Füreder, MD

Eléonore Longton, MD

Sandra Nuyts, MD

Zahari Zahariev, MD

Iglika Mihaylova, MD

Khalil Sultanem, MD

Shaojun Lin, MD

Jinxing Hong, MD

Fuolong Liu, MD

Yajie Liu, MD

Xicheng Wang, MD

Xiaodong Zhu, MD

Desheng Hu, MD

Guangyuan Hu, MD

Feng Liu, MD

Longzhen Zhang, MD

Jin-gao Li, MD

Zhixiang Zhuang, MD

Bingjian Huang, MD

Yufeng Cheng, MD

Jinming Yu, MD, PhD

Hongwei Li, MD

Ping Wang, MD

Melichar Bohuslav, MD, PhD

Holeckova Petra, MD

Sirpa-Liisa Lahtela, MD

Etienne Fessart, MD

Ulrike Schick, MD, PhD

Xavier Liem, MD

Jérôme Fayette, MD, PhD

Sebastien Salas, MD, PhD

Jean-Michel Vannetzel, MD

Haïtham Mirghani, MD, PhD

Florence Huguet, MD, PhD

Maria Lesnik, MD

Charles Dupin, MD

Sébastien Thureau, MD, PhD

Franck Drouet, MD

Eric Jadaud, MD

Joseph Rodriguez, MD

Sophie Renard, MD

Thanh-Van Nguyen, MD

Tamta Makharadze, MD

Eteri Natelauri, MD, PhD

Giorgi Kristesashvili, MD

Miranda Gogishvili, MD

Jens Peter Klußmann, MD

Christine Langer, MD

Athanasia Warnecke, MD

Orlando Guntinas-Lichius, MD,PhD

Stephanie Combs, MD

Guido Hildebrandt, MD, PhD

Thomas Christian Hoffmann, MD

Amanda Psyrri, MD, PhD

Athanasios Panayioti Kotsakis, MD, PhD

Ioannis Petros Boukovinas, MD, PhD

Frigyes Helfferich, MD, PhD

Zoltán Takácsi-Nagy, MD, PhD

Katalin Hideghéty, MD, PhD

Eli Sapir, MD

Salem Billan, MD

Aron Popovtzer, MD

Orit Gutfeld, MD

Tsutomu Ueda, MD, PhD

Kaoru Tanaka, MD, PhD

Takashi Fujii, MD, PhD

Hye Ryun Kim, MD

Hyun Woo Lee, MD

Ho Jung An, MD

Filipa Pereira, MD

Leonor Ribeiro, MD

Diogo Alpuim Costa, MD

Rodica-Maricela Anghel, MD, PhD

Natasa Jovanovic-Korda, MD

Stosic Srboljub, MD

Borislava Nikolin, MD, PhD

Jasmina Nedovic, MD

Jon Cacicedo Fernandez Bobadilla, MD

Neus Basté Rotllan, MD

Jordi Giralt, MD, PhD

Lara Carmen Iglesias Docampo, MD

Fernando Arias De La Vega, MD, PhD

Almudena García Castaño, MD

Jin-Ching Lin, MD

Shang-Yin Wu, MD

Hsiang-Fong Kao, MD

Christophe Le Tourneau, MD, PhD

This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy/performance and safety of NBTXR3/RT±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with LA-HNSCC.

This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy/performance and safety of NBTXR3/RT±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with LA-HNSCC.

Participants will undergo a screening assessment over a period of ≤28 days to determine eligibility. One primary tumor lesion that is amenable for intratumoral injection, as determined by the Investigator

Eligible participants will be treated by the Investigator's choice of RT alone or RT in combination with cetuximab. Following the Investigator's choice, participants will be randomized in a 1:1 ratio on Day:

* Arm A: NBTXR3, as an intratumoral/intranodal injection, activated by investigator's choice of RT alone or RT in combination with cetuximab
* Arm B: Investigator's choice of RT alone or RT in combination with cetuximab

All participants (Arm A and Arm B) will receive 70 Gy in 35 fractions over a 7 week period.

An EOT visit will be performed 4 weeks after the completion of RT. Follow-up visits will start at 12 weeks post-RT completion, and will continue every 12 weeks for 2 years, and then every 24 weeks thereafter until death; the participant is determined to be lost to follow up; withdrawal of consent; or the end of the study, whichever occurs first. Participants who have received further anti-cancer therapy for the study disease and/or have had disease progression/recurrence will be followed only for survival information

NBTXR3 With or Without Cetuximab in LA-HNSCC

A Phase 3 Study of NBTXR3 Activated by Investigator's Choice of Radiotherapy Alone or Radiotherapy in Combination With Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients With LA-HNSCC

Time from randomization to local-regional recurrence, local-regional progression, distant progression, or death from any cause, whichever occurs first

Time from randomization to death from any cause

Time to local regional progression: time from Randomization to local-regional progression or death, whichever occurs first

Time to distant progression: time from Randomization to distant progression or death, whichever occurs first

Rate of complete response (CR)+partial response (PR) \[RESIST 1.1\]

Time from CR or PR to progression of disease, unequivocal clinical progression, or death, whichever occurs first

Change from baseline over time in symptoms, function, and health related QOL using the European Organisation for Research and Treatment of Cancer (EORTC) questionnaire-Head and Neck Cancer Module (QLQ H\&N35)

Change from baseline over time in symptoms, function, and health related QOL using the 5 level EuroQol 5 dimension (EQ 5D 5L) instrument

Nanobiotix

Spots Global Cancer Trial Database for hafnium oxide