JNJ-90301900 (NBTXR3) Activated by Radiotherapy 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 Locally Advanced Head & Neck Squamous Cell Carcinoma

This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy and safety of JNJ-90301900 (NBTXR3) / radiation therapy (RT)±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with locally advanced head and neck squamous cell carcinoma (LA-HNSCC).

Study Overview

• Status: Recruiting
• Conditions: Carcinoma, Squamous Cell
• Intervention / Treatment: Radiation: Radiation Therapy; Drug: Cetuximab; Drug: JNJ-90301900 (NBTXR3)

Detailed Description

Participants will undergo a screening assessment over a period of less than or equal to (<=) 28 days to determine eligibility.

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:

• Arm A: JNJ-90301900 (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

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• Austria
  • Graz, Austria, 8036
    • Completed
    • Medizinische Universität Graz
  • Linz, Austria, 4010
    • Recruiting
    • Ordensklinikum Linz GmbH Barmherzige Schwestern
  • Vienna, Austria, 1090
    • Recruiting
    • Medizinische Universitaet Wien
• Belgium
  • Brussels, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires Saint Luc
  • Charleroi, Belgium, 6060
    • Recruiting
    • Grand Hopital De Charleroi Site Les Viviers
  • Leuven, Belgium, 3000
    • Recruiting
    • Universitair Ziekenhuis Leuven
• Brazil
  • Barretos, Brazil, 14784
    • Recruiting
    • Fundação Pio XII - Hospital de Câncer de Barretos
  • Belo Horizonte, Brazil, 30380 472
    • Recruiting
    • Nucleo de Ensino e Pesquisa do Instituto Mario Penna
  • Fortaleza, Brazil, 60430-230
    • Recruiting
    • Hospital Haroldo Juacaba - Instituto do Cancer do Ceara
  • Fortaleza, Brazil, 60336 232
    • Recruiting
    • Centro Regional Integrado de Oncologia CRIO
  • Ipatinga, Brazil, 35160 158
    • Recruiting
    • Fundação Sao Francisco Xavier
  • Jaú, Brazil, 17210120
    • Recruiting
    • Hospital Amaral Carvalho
  • Londrina, Brazil, 86015 520
    • Recruiting
    • Hospital do Câncer de Londrina
  • Porto Alegre, Brazil, 90050-170
    • Recruiting
    • Irmandade da Santa Casa de Misericordia de Porto Alegre
  • Porto Alegre, Brazil, 90610-000
    • Recruiting
    • Hospital Sao Lucas Da Pucrs
  • Porto Alegre, Brazil, 91350-200
    • Completed
    • Hospital Nossa Senhora da Conceicao
  • Rio de Janeiro, Brazil, 22250-905
    • Recruiting
    • Grupo Oncoclinicas - Botafogo
  • Salvador, Brazil, 41950 640
    • Recruiting
    • Ensino E Terapia de Inovacao Clinica Amo Etica
  • São José do Rio Preto, Brazil, 15090-000
    • Recruiting
    • Hospital de Base de Sao Jose do Rio Preto
  • São Paulo, Brazil, 01246 000
    • Recruiting
    • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
  • São Paulo, Brazil, 01308-050
    • Recruiting
    • Hospital Sirio Libanes Sao Paulo
  • Vitória, Brazil, 29043 260
    • Recruiting
    • Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
• Bulgaria
  • Panagyurishte, Bulgaria, 4500
    • Completed
    • MHAT Uni Hospital
  • Sofia, Bulgaria, 1756
    • Completed
    • Specialized Hospital for Active Treatment in Oncology
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook Health Sciences Center
• China
  • Bengbu, China, 233004
    • Completed
    • The Affiliated Hospital of Bengbu Medical College
  • Changsha, China, 410013
    • Recruiting
    • Hunan Cancer Hospital
  • Changsha, China, 410008
    • Completed
    • Xiangya Hospital Central South University
  • Chengdu, China, 610041
    • Recruiting
    • Sichuan Cancer Hospital
  • Dongguan, China, 523109
    • Recruiting
    • Dongguan People s Hospital
  • Fuzhou, China, 350005
    • Recruiting
    • The First Affiliated Hospital of Fujian Medical University
  • Fuzhou, China, 350001
    • Completed
    • Fujian Medical University Union Hospital
  • Fuzhou, China, 350014
    • Recruiting
    • Fujian Medical University Fujian Provincial Cancer Hospital
  • Guangzhou, China, 510180
    • Recruiting
    • Guangzhou First Municipal People's Hospital
  • Guangzhou, China, 510080
    • Recruiting
    • The First Affiliated Hospital of Guangdong Pharmaceutical University
  • Guangzhou, China, 510095
    • Recruiting
    • Guangzhou Medical University Affiliated Oncology Hospital
  • Jinan, China, 250012
    • Recruiting
    • Qilu Hospital of Shandong University
  • Jinan, China, 250117
    • Recruiting
    • Shandong Cancer Hospital
  • Linyi, China, 276002
    • Recruiting
    • LinYi Cancer Hospital
  • Liuzhou, China, 545006
    • Recruiting
    • Liuzhou People's Hospital
  • Nanchang, China, 330029
    • Completed
    • Jiangxi Cancer Hospital
  • Nanjing, China, 223800
    • Recruiting
    • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
  • Nanjing, China, 210009
    • Completed
    • Jiangsu Cancer Hospital
  • Nanning, China, 530000
    • Recruiting
    • Wuming Hospital of Guangxi Medical University
  • Nanning, China, 530021
    • Recruiting
    • The Cancer Hospital Affiliated to Guangxi Medical University
  • Qingdao, China, 266003
    • Recruiting
    • The Affiliated Hospital of Medical College Qingdao University
  • Shanghai, China, 200032
    • Completed
    • Fudan University Shanghai Cancer Center
  • Shenyang, China, 110042
    • Completed
    • Liaoning Cancer Hospital and Institute
  • Shenzhen, China, 518036
    • Recruiting
    • Peking University Shenzhen Hospital
  • Shijiazhuang, China, 50011
    • Recruiting
    • The Fourth Hospital of Hebei Medical University
  • Suzhou, China, 215004
    • Completed
    • Second Affiliated Hospital, SooChow University
  • Taiyuan, China, 30013
    • Completed
    • Shanxi Provincial Cancer Hospital
  • Tianjin, China, 300060
    • Completed
    • Tianjin Medical University Cancer Institute and Hospital
  • Wuhan, China, 430022
    • Recruiting
    • Union Hospital Tongji Medical College of Huazhong University of Science and Technology
  • Wuhan, China, 430079
    • Recruiting
    • Hubei Cancer Hospital
  • Wuhan, China, 430030
    • Recruiting
    • Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
  • Xiamen, China, 361003
    • Completed
    • The First Affiliated Hospital of Xiamen University
  • Xuzhou, China, 221000
    • Completed
    • The Affiliated Hospital of Xuzhou Medical University
  • Zhengzhou, China, 450008
    • Completed
    • Henan Cancer Hospital
  • Zhuhai, China, 519000
    • Recruiting
    • The Fifth Affiliated Hospital Sun Yat Sen University
• Croatia
  • Zagreb, Croatia, 10000
    • Completed
    • Klinicki Bolnicki Centar Zagreb
• Czechia
  • Prague, Czechia, 180 81
    • Active, not recruiting
    • Nemocnice Bulovka
• Finland
  • Tampere, Finland, 33520
    • Completed
    • Tampereen yliopistollinen sairaala
• France
  • Amiens, France, 80000
    • Recruiting
    • CHU Amiens Picardie
  • Brest, France, 29609
    • Recruiting
    • CHU Brest
  • Caen, France, 14076
    • Recruiting
    • Centre Francois Baclesse
  • Dijon, France, 21000
    • Recruiting
    • Centre Georges François Leclerc
  • Lille, France, 59020
    • Recruiting
    • Centre de Lutte contre le Cancer Centre Oscar Lambret
  • Lyon, France, 69008
    • Completed
    • Centre Leon Berard
  • Marseille, France, 13385
    • Recruiting
    • Hopital de la Timone
  • Neuilly-sur-Seine, France, 92200
    • Completed
    • Clinique Ambroise Pare
  • Paris, France, 75015
    • Recruiting
    • Hôpital Européen Georges Pompidou
  • Paris, France, 75248
    • Recruiting
    • Institut Curie
  • Paris, France, 75970
    • Recruiting
    • Hôpital Tenon
  • Pessac, France, 33604
    • Recruiting
    • Hopital Haut Leveque
  • Rennes, France, 35000
    • Recruiting
    • Hôpital Pontchaillou
  • Rouen, France, 76038
    • Recruiting
    • CLCC - Centre Henri Becquerel
  • Saint-Etienne, France, 42055
    • Recruiting
    • CHU Saint Etienne
  • Valenciennes, France, 59322
    • Completed
    • Centre Hospitalier de Valenciennes Hopital Jean Bernard
  • Vandœuvre-lès-Nancy, France, 54500
    • Recruiting
    • Institut de Cancerologie de Lorraine
  • Villejuif, France, 94805
    • Recruiting
    • Gustave Roussy
• Georgia
  • Batumi, Georgia, 6000
    • Recruiting
    • High Technology Hospital MedCenter Ltd Batumi
  • Kutaisi, Georgia, 4600
    • Recruiting
    • JSC Vian Kutaisi Referral Hospital
  • Tbilisi, Georgia, 144
    • Recruiting
    • LTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
  • Tbilisi, Georgia, 0112
    • Completed
    • Todua Clinic
• Germany
  • Giessen, Germany, 35392
    • Recruiting
    • Universitaetsklinikum Giessen Und Marburg Gmbh
  • Hanover, Germany, 30625
    • Recruiting
    • Medizinische Hochschule Hannover
  • Jena, Germany, 07747
    • Recruiting
    • Universitätsklinikum Jena
  • München, Germany, 81675
    • Completed
    • Klinikum rechts der Isar an der Technischen Universitat Munchen
  • Rostock, Germany, 18059
    • Recruiting
    • Universitaetsmedizin Rostock
• Greece
  • Athens, Greece, 124 62
    • Recruiting
    • University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
  • Larissa, Greece, 41110
    • Recruiting
    • University Hospital of Larissa
  • Thessaloniki, Greece, 57001
    • Completed
    • Interbalkan Medical Center of Thessaloniki
  • Thessaloniki, Greece, 54639
    • Recruiting
    • Athens Medical Center S A Interbalkan Medical Center of Thessaloniki
• Hungary
  • Budapest, Hungary, 1122
    • Recruiting
    • Országos Onkológiai Intézet
  • Budapest, Hungary, 1062
    • Completed
    • Eszak Pesti Centrumkorhaz Honvedkorhaz
  • Szeged, Hungary, 6720
    • Recruiting
    • Szent Gyorgyi Albert Klinikai Kozpont Onkoterapias Klinika
• India
  • Bangalore, India, 560054
    • Recruiting
    • M S Ramaiah Memorial Hospital
  • Chennai, India, 600035
    • Completed
    • Apollo Speciality Hospital, Chennai
  • Madurai, India, 625107
    • Completed
    • Meenakshi Mission Hospital and Research Center
  • Mumbai, India, 400012
    • Recruiting
    • Tata Memorial hospital
  • Nashik, India, 422002
    • Recruiting
    • HealthCare Global HCG Manavata Cancer Centre
  • New Delh, India, 110085
    • Recruiting
    • Rajiv Gandhi Cancer Institute And Research Centre
  • Pune, India, 411 001
    • Completed
    • Grant Medical Foundation Ruby Hall Clinic
  • Vijayawada, India, 520002
    • Recruiting
    • HCG cancer center
• Israel
  • Ashdod, Israel, 7747629
    • Completed
    • Samson Assuta Ashdod University Hospital
  • Haifa, Israel, 3109601
    • Completed
    • Rambam Health Care Campus
  • Jerusalem, Israel, 9112001
    • Completed
    • Hadassah Medical Center
  • Tel Aviv, Israel, 6423906
    • Completed
    • Tel Aviv Sourasky Medical Center
• Japan
  • Bunkyō City, Japan, 113-8519
    • Recruiting
    • Tokyo Medical and Dental University Hospital
  • Hiroshima, Japan, 734 8551
    • Recruiting
    • Hiroshima University Hospital
  • Kashiwa, Japan, 277-8577
    • Recruiting
    • National Cancer Center Hospital East
  • Nagoya, Japan, 464-8681
    • Recruiting
    • Aichi Cancer Center
  • Osaka, Japan, 541 8567
    • Recruiting
    • Osaka International Cancer Institute
  • Osaka Sayama Shi, Japan, 589 8511
    • Completed
    • Kindai University Hospital
  • Sendai, Japan, 980 8574
    • Recruiting
    • Tohoku University Hospital
  • Shimotsuke, Japan, 329-0498
    • Recruiting
    • Jichi Medical University Hospital
  • Shinjuku, Japan, 160 0023
    • Recruiting
    • Tokyo Medical University Hospital
  • Sunto Gun, Japan, 411 8777
    • Recruiting
    • Shizuoka Cancer Center
• Philippines
  • Las Piñas, Philippines, 1742
    • Completed
    • University of Perpetual Help Dalta Medical Center, Inc
  • Manila, Philippines, 1000
    • Completed
    • Manila Doctors Hospital
  • Pasig, Philippines, 1600
    • Recruiting
    • The Medical City
  • Quezon City, Philippines, 1112
    • Recruiting
    • St. Luke's Medical Center
• Portugal
  • Braga, Portugal, 4710 243
    • Completed
    • Uls Braga - Hosp. Braga
  • Lisbon, Portugal, 1649 035
    • Completed
    • Uls Santa Maria - Hosp. Santa Maria
  • Lisbon, Portugal, 1998050
    • Recruiting
    • Hosp. Cuf Descobertas
  • Porto, Portugal, 4099-001
    • Completed
    • Uls Santo Antonio - Hosp. Santo Antonio
  • Vila Nova de Gaia, Portugal, 4434 502
    • Recruiting
    • Uls Gaia Espinho
• Romania
  • Bucharest, Romania, 22328
    • Recruiting
    • Institutul Oncologic Prof Dr Al Trestioreanu Bucuresti
• Serbia
  • Belgrade, Serbia, 11000
    • Completed
    • Institute of Oncology and Radiology of Serbia
  • Belgrade, Serbia, 11000
    • Completed
    • Vojnomedicinska Akademija
  • Kamenitz, Serbia, 21204
    • Completed
    • Institute of Oncology of Vojvodina
  • Kragujevac, Serbia, 34000
    • Completed
    • University Clinical Center Kragujevac
• South Korea
  • Seoul, South Korea, 05505
    • Recruiting
    • Asan Medical Center
  • Seoul, South Korea, 03722
    • Recruiting
    • Severance Hospital Yonsei University Health System
  • Seoul, South Korea, 06591
    • Recruiting
    • The Catholic University of Korea Seoul St Mary s Hospital
  • Suwon, South Korea, 16247
    • Recruiting
    • The Catholic University of Korea, St. Vincent'S Hospital
• Spain
  • Barakaldo, Spain, 48903
    • Recruiting
    • Hosp. Univ. de Cruces
  • Barcelona, Spain, 8035
    • Recruiting
    • Hosp Univ Vall D Hebron
  • Barcelona, Spain, 08036
    • Completed
    • Hosp Clinic de Barcelona
  • L'Hospitalet de Llobregat, Spain, 08908
    • Recruiting
    • Instituto Catalan Deoncologia Hospital Duran I Reynals
  • Las Palmas de Gran Canaria, Spain, 35001
    • Completed
    • Hospitales Universitarios San Roque En Las Palmas de Gran Canaria Centro Oncologico Integral Canario
  • Lugo, Spain, 27003
    • Recruiting
    • Hosp. Univ. Lucus Augusti
  • Madrid, Spain, 28041
    • Recruiting
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28007
    • Recruiting
    • Hosp. Gral. Univ. Gregorio Maranon
  • Madrid, Spain, 28040
    • Recruiting
    • Hosp Univ Fund Jimenez Diaz
  • Madrid, Spain, 28050
    • Recruiting
    • Hosp Univ Hm Sanchinarro
  • Málaga, Spain, 29010
    • Recruiting
    • Hosp Regional Univ de Malaga
  • Pamplona, Spain, 31008
    • Completed
    • Hosp. de Navarra
  • Santander, Spain, 39008
    • Recruiting
    • Hosp. Univ. Marques de Valdecilla
  • Seville, Spain, 41013
    • Recruiting
    • Hosp. Virgen Del Rocio
  • Valencia, Spain, 46014
    • Recruiting
    • Hosp. Gral. Univ. Valencia
  • Valencia, Spain, 46009
    • Recruiting
    • Inst. Valenciano de Oncologia
  • Zaragoza, Spain, 50009
    • Recruiting
    • Hosp. Clinico Univ. Lozano Blesa
• Sweden
  • Gothenburg, Sweden, 41345
    • Completed
    • Sahlgrenska Universitetssjukhuset
• Taiwan
  • Bei Qu, Taiwan, 704
    • Recruiting
    • National Cheng Kung University Hospital
  • Changhua, Taiwan, 500
    • Recruiting
    • Changhua Christian Hospital
  • Keelung, Taiwan, 20442
    • Recruiting
    • Chang-Gung Memorial Hospital-Keelung
  • Taichung, Taiwan, 40705
    • Recruiting
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
• United Kingdom
  • Edinburgh, United Kingdom, EH4 2XU
    • Recruiting
    • Western General Hospital
  • Glasgow, United Kingdom, G12 0YN
    • Recruiting
    • NHS Greater Glasgow and Clyde
  • Guildford, United Kingdom, GU2 7XX
    • Recruiting
    • The Royal Surrey County Hospital NHS Foundation Trust
  • London, United Kingdom, SW3 6JJ
    • Recruiting
    • The Royal Marsden NHS Foundation Trust
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Recruiting
    • Newcastle upon Tyne Hospitals NHS Foundation Trust
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama at Birmingham
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope
    • La Jolla, California, United States, 92093
      • Recruiting
      • University of California at San Diego Moores Cancer Center
    • Laguna Hills, California, United States, 92653
      • Completed
      • Memorial Radiation Oncology Medical Group Laguna Hills
    • Los Angeles, California, United States, 90095
      • Recruiting
      • UCLA Hematology Oncology
    • Newport Beach, California, United States, 92663
      • Completed
      • Hoag Memorial Hospital
    • San Francisco, California, United States, 94158
      • Recruiting
      • University of California San Francisco
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20052
      • Recruiting
      • George Washington University Cancer Center
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic Jacksonville
    • Orlando, Florida, United States, 32803
      • Recruiting
      • AdventHealth Orlando
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Recruiting
      • Emory University Hospital Midtown
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Recruiting
      • University of Kentucky Markey Cancer Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Boston Medical Center
  • New Mexico
    • Santa Fe, New Mexico, United States, 87505
      • Completed
      • CHRISTUS St. Vincent Regional Cancer Center
  • New York
    • New York, New York, United States, 10032
      • Completed
      • Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
    • Staten Island, New York, United States, 10310
      • Recruiting
      • Richmond University Medical Center
      • Contact: Shanmugappiriya Sivarajah
    • The Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Recruiting
      • University of North Carolina at Chapel Hill
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Atrium Health Levine Cancer Institute
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • University of Cincinnati
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Recruiting
      • Stephenson Cancer Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health and Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania Perelman Center for Advanced Medicine
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia
    • Norfolk, Virginia, United States, 23507
      • Recruiting
      • Macon Joan Brock Virginia Health Sciences Eastern Virginia Medical Group at Old Dominion University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age greater than or equal to (>=) 60 years old
• Biopsy-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx and a candidate for definitive radiation therapy with or without cetuximab
• Clinical stage T3-4 NX or T2 N2-3 disease according to the 8th edition of AJCC
• One primary tumor lesion amendable for intratumoral injection

• Ineligible to receive platinum-based chemotherapy with radiation (at least one of the following):

  1. Estimated creatinine clearance >= 30 and less than (<) 50 milliliters/minute (mL/min) (per Cockcroft-Gault equation),
  2. Grade >= 2 hearing loss or tinnitus,
  3. Grade >= 2 peripheral neuropathy,
  4. New York Heart Association Class 3
  5. Aged 70-74 years old with Geriatric 8 (G8) score less than or equal to (<=) 14 or Aged >= 75 years old
• Eastern cooperative oncology group (ECOG) performance status 0 to 1
• Life expectancy >= 6 months

Exclusion Criteria:

• Carcinoma of the nasopharynx, paranasal sinus, salivary gland, or thyroid gland; or non-squamous histology or SCC of unknown primary origin
• Clinical stage T1-2 N0, T2 N1, or M1 disease according to the 8th edition of AJCC
• Loco-regionally recurrent head & neck cancer that has been previously treated with surgery, radiation therapy, and/or chemotherapy
• Prior or concurrent primary malignancy (including second synchronous head & neck cancer) within the last 2 years of informed consent and whose natural history has the potential to interfere with the safety and efficacy assessment of the investigational agent
• Ongoing or active infection requiring treatment with antimicrobial therapy within 2 weeks of randomization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: JNJ-90301900 (NBTXR3); JNJ-90301900 (NBTXR3), as an intratumoral/intranodal injection, activated by investigator's choice of RT alone or RT in combination with cetuximab. JNJ-90301900 (NBTXR3) is given as a dose of 33% of the Gross Tumor Volume.	Radiation: Radiation Therapy; Intensity-modulated radiation therapy (IMRT): 70 Gray in 35 fractions over a 7-week period.; Drug: Cetuximab; Solution for infusion; Other Names: Erbitux; Drug: JNJ-90301900 (NBTXR3); Suspension of inert, crystalline hafnium oxide particles, designed to generate oxygen free radicals to destroy cancer cells after activation by ionizing radiation.; Other Names: NBTXR3; Functionalized hafnium oxide nanoparticles
Active Comparator: Arm B: RT alone or RT in combination with cetuximab; Investigator's choice of RT alone or RT in combination with cetuximab.	Radiation: Radiation Therapy; Intensity-modulated radiation therapy (IMRT): 70 Gray in 35 fractions over a 7-week period.; Drug: Cetuximab; Solution for infusion; Other Names: Erbitux

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS) Based on Independent Central Review (ICR)	PFS is defined as time from randomization to local-regional progression (including recurrence), distant progression, or death from any cause, whichever occurs first.	30 months following first randomized participant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Time from randomization to death from any cause.	48 months following first randomized participant
Local-regional control	Time to local regional progression: time from randomization to local-regional progression (including recurrence) or death, whichever occurs first.	48 months following first randomized participant
Distant control	Time to distant progression: time from randomization to distant progression or death, whichever occurs first.	48 months following first randomized participant
Quality of Life over time - QLQ H&N35	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).	48 months following first randomized participant
Quality of Life over time - EQ 5D 5L	Change from baseline over time in symptoms, function, and health related QOL using the 5 level EuroQol 5 dimension (EQ 5D 5L) instrument.	48 months following first randomized participant
Safety across duration of study - AEs	Adverse events (AEs).	48 months following first randomized participant
Objective Response Rate (ORR)	Rate of complete response (CR)+partial response (PR) [RESIST 1.1].	48 months following first randomized participant
Duration of Overall Response	Time from CR or PR to progression of disease, unequivocal clinical progression, or death, whichever occurs first.	48 months following first randomized participant
Head and Neck Cancer Specific Event-Free Survival	Time from randomization to loco regional progression (including recurrence), distant progression, or head and neck cancer related death, as per RECIST 1.1, whichever occurs first.	48 months following first randomized participant
Head and Neck Cancer-Specific Survival	Time from randomization to head and neck cancer-related death.	48 months following first randomized participant

Collaborators and Investigators

• Sponsor: Johnson & Johnson Enterprise Innovation Inc.
• Investigators: Study Director: Johnson & Johnson Enterprise Innovation Inc Clinical trial, Johnson & Johnson Enterprise Innovation Inc.

Publications and helpful links

General Publications

• Le Tourneau C, Takacsi-Nagy Z, Nuyts S, Thureau S, Liu F, Hoffmann C, Hackman TG, Lesnik M, Debard A, Finzi L, Devisetty K, Vivar OI, Farber LA, Nguyen F, Liem X, Natelauri E, Psyrri A, Burian M, Yu J, Yom SS. Nanoray-312: phase III study of NBTXR3 + radiotherapy +/- cetuximab in elderly, platinum-ineligible locally advanced HNSCC. Future Oncol. 2025 May;21(12):1489-1499. doi: 10.1080/14796694.2025.2496131. Epub 2025 May 5.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2021
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: May 4, 2021
• First Submitted That Met QC Criteria: May 13, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Radiotherapy; radiation therapy; HNSCC; RT; LA-HNSCC; NBTXR3; hafnium oxide; radioenhancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Neoplasms, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell; Amino Acids, Peptides, and Proteins; Proteins; Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Cetuximab; Radiotherapy
• Other Study ID Numbers: NANORAY-312 (Other Identifier: Janssen Research & Development, LLC); 2024-520386-31-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No