Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Head and Neck Neoplasms

Pharmaceutical Solutions

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

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

Sylvie BONVALOT, MD-PhD

Guy KANTOR, MD-PhD

RATIONALE: Radiation therapy given before surgery of soft tissue sarcoma decreases the size of the tumor mass and the presence of malignant cells in its peripheral region. NBTXR3 and radiation therapy may kill more cancer cells and increase the tumor shrinkage rendering surgery more feasible or easier and achieve better local control of the tumor.

PURPOSE: This Phase I trial aims at evaluating the feasibility of the NBTXR3 injection in the tumor, safety and the adequate dose of NBTXR3 when given with radiation therapy.

Patients will receive a single intratumor injection of NBTXR3 on day 1 and will receive external beam radiotherapy starting on day 2 up to completion of 5 weeks, 5 days a week of treatment (50Gy, 2Gy/fraction). Then, all patients will undergo surgical resection of the tumor 5 weeks later and will be followed for wound healing and toxicity assessment. A visit of end of treatment will take place approximately 3-4 weeks after surgery. Patients will be followed for evaluation of their disease status and adverse events every 8 weeks until the end of study.

NBTXR3 Crystalline Nanoparticles and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma of the Extremity

An Open-Label, Single Arm, Feasibility And Safety Phase I Study With NBTXR3 Intratumor Implantation (By Injection) And Activated By External Beam Radiation Therapy In Patients With Soft Tissue Sarcoma Of The Extremity And Trunk Wall

- To evaluate the feasibility of NBTXR3 given as intratumor implantation (by injection) and activated by external beam radiation in patients with soft tissue sarcoma of the extremity and trunk wall

- To assess the safety profile and determine the early dose limiting toxicity (DLT) of NBTXR3 intratumor implantation (by injection) and activated by external beam radiation

- To evaluate the anti-tumor activity of NBTXR3 implanted within the tumor (by injection) at Day 1 and activated 24 hours later by external beam radiation therapy in terms of pathological Response (pR)

- To evaluate the Response Rate (RR) of NBTXR3 implanted within the tumor (by injection) at Day 1 and activated 24 hours later by external beam radiation therapy as per RECIST

- To characterize the body kinetic profile of NBTXR3 implanted within the tumor (by injection) at Day 1 and Day 2 before its activation by radiation therapy

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Mouth and Tooth Diseases

Neoplasm Metastasis

Breast Neoplasms

Urinary Bladder Neoplasms

Uterine Cervical Neoplasms

Melanoma

Carcinoma, Renal Cell

Liver Neoplasms

Microsatellite Instability

Mouth Neoplasms

Melanoma, Cutaneous Malignant

Neoplasms, Second Primary

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neoplastic Processes

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urologic Diseases

Male Urogenital Diseases

Breast Diseases

Genomic Instability

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urinary Bladder Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Oral Cancer

Neuroendocrine Tumor

Neuroepithelioma

Hematinics

Pembrolizumab

Nivolumab

Liver Extracts

Immune Checkpoint Inhibitors

Intratumoral injection of NBTXR3 followed by SABR followed by monotherapy with nivolumab or pembrolizumab

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
NBTXR3 With or Without Cetuximab in LA-HNSCC	NCT04892173	Locally Advance... Aged	NBTXR3 Cetuximab Radiation Thera...	65 Years -	Nanobiotix
NBTXR3 Crystalline Nanoparticles and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma of the Extremity	NCT01433068	Adult Soft Tiss...	NBTXR3	18 Years -	Nanobiotix
NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy	NCT03589339	Radiotherapy Immunotherapy Microsatellite ... Metastasis From... Squamous Cell C... Metastasis From... Metastatic Rena... Metastasis From... Metastatic Trip... Metastatic NSCL... Metastasis From...	NBTXR3 SABR Nivolumab Pembrolizumab	18 Years -	Nanobiotix
NBTXR3 Crystalline Nanoparticles and Radiation Therapy in Treating Randomized Patients in Two Arms With Soft Tissue Sarcoma of the Extremity and Trunk Wall	NCT02379845	Adult Soft Tiss...	NBTXR3 Radiation thera...	18 Years -	Nanobiotix
NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy	NCT03589339	Radiotherapy Immunotherapy Microsatellite ... Metastasis From... Squamous Cell C... Metastasis From... Metastatic Rena... Metastasis From... Metastatic Trip... Metastatic NSCL... Metastasis From...	NBTXR3 SABR Nivolumab Pembrolizumab	18 Years -	Nanobiotix
NBTXR3 Crystalline Nanoparticles and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma of the Extremity	NCT01433068	Adult Soft Tiss...	NBTXR3	18 Years -	Nanobiotix

Spots Global Cancer Trial Database for nbtxr3

Every month we try and update this database with for nbtxr3 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nbtxr3

Every month we try and update this database with for nbtxr3 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nbtxr3 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.