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NCT04892173PHASE3Recruiting

JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC

Johnson & Johnson Enterprise Innovation Inc.

Start Date

12/10/2021

Completion Date

6/30/2028

Summary

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).

Eligibility Criteria

Age Range: 60 years to No maximum

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

Interventions

DRUG

JNJ-90301900 (NBTXR3)

DRUG

Cetuximab

RADIATION

Radiation Therapy

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Conditions

Carcinoma, Squamous Cell

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35294

United States

City of Hope

Duarte, California 91010

United States

University of California at San Diego Moores Cancer Center

La Jolla, California 92093

United States

Memorial Radiation Oncology Medical Group Laguna Hills

Laguna Hills, California 92653

United States

UCLA Hematology Oncology

Los Angeles, California 90095

United States

Hoag Memorial Hospital

Newport Beach, California 92663

United States

University of California San Francisco

San Francisco, California 94158

United States

George Washington University Cancer Center

Washington D.C., District of Columbia 20052

United States

Mayo Clinic Jacksonville

Jacksonville, Florida 32224

United States

AdventHealth Orlando

Orlando, Florida 32803

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Emory University Hospital Midtown

Atlanta, Georgia 30308

United States

University of Kentucky Markey Cancer Center

Lexington, Kentucky 40536

United States

Boston Medical Center

Boston, Massachusetts 02118

United States

Christus St. Vincent Regional Cancer Center

Santa Fe, New Mexico 87505

United States

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

New York, New York 10032

United States

Richmond University Medical Center

Staten Island, New York 10310

United States

Montefiore Medical Center

The Bronx, New York 10467

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27514

United States

Atrium Health Levine Cancer Institute

Charlotte, North Carolina 28204

United States

University of Cincinnati

Cincinnati, Ohio 45219

United States

Stephenson Cancer Center

Oklahoma City, Oklahoma 73104

United States

Oregon Health And Science University

Portland, Oregon 97239

United States

University of Pennsylvania Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania 19104

United States

University of Virginia

Charlottesville, Virginia 22908

United States

Macon Joan Brock Virginia Health Sciences Eastern Virginia Medical Group at Old Dominion University

Norfolk, Virginia 23507

United States

Medizinische Universitat Graz

Graz, 8036

Austria

Ordensklinikum Linz GmbH Barmherzige Schwestern

Linz, 4010

Austria

Medizinische Universitaet Wien

Vienna, 1090

Austria

Cliniques Universitaires Saint Luc

Brussels, 1200

Belgium

Grand Hopital De Charleroi Site Les Viviers

Charleroi, 6060

Belgium

Universitair Ziekenhuis Leuven

Leuven, 3000

Belgium

Fundacao Pio Xii - Hospital De Cancer De Barretos

Barretos, 14784

Brazil

Nucleo de Ensino e Pesquisa do Instituto Mario Penna

Belo Horizonte, 30380 472

Brazil

Centro Regional Integrado de Oncologia CRIO

Fortaleza, 60336 232

Brazil

Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará

Fortaleza, 60430-230

Brazil

Fundacao Sao Francisco Xavier

Ipatinga, 35160 158

Brazil

Hospital Amaral Carvalho

Jaú, 17210120

Brazil

Hospital do Cancer de Londrina

Londrina, 86015 520

Brazil

Irmandade da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, 90050-170

Brazil

Hospital Sao Lucas da PUCRS

Porto Alegre, 90610-000

Brazil

Hospital Nossa Senhora da Conceicao

Porto Alegre, 91350-200

Brazil

Grupo Oncoclinicas - Botafogo

Rio de Janeiro, 22250-905

Brazil

Ensino e Terapia de Inovacao Clinica AMO Etica

Salvador, 41950 640

Brazil

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, 15090-000

Brazil

Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

São Paulo, 01246 000

Brazil

Hospital Sirio Libanes Sao Paulo

São Paulo, 01308-050

Brazil

Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia

Vitória, 29043 260

Brazil

MHAT Uni Hospital

Panagyurishte, 4500

Bulgaria

Specialized Hospital for Active Treatment in Oncology

Sofia, 1756

Bulgaria

Sunnybrook Health Sciences Center

Toronto, Ontario M4N 3M5

Canada

The Affiliated Hospital of Bengbu Medical College

Bengbu, 233004

China

Xiangya Hospital Central South University

Changsha, 410008

China

Hunan Cancer hospital

Changsha, 410013

China

Sichuan Cancer Hospital

Chengdu, 610041

China

Dongguan People s Hospital

Dongguan, 523109

China

Fujian Medical University Union Hospital

Fuzhou, 350001

China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, 350005

China

Fujian Medical University Fujian Provincial Cancer Hospital

Fuzhou, 350014

China

The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, 510080

China

Guangzhou Medical University Affiliated Oncology Hospital

Guangzhou, 510095

China

Guangzhou First Municipal People's Hospital

Guangzhou, 510180

China

Qilu Hospital of Shandong University

Jinan, 250012

China

Shandong Cancer Hospital

Jinan, 250117

China

Linyi Cancer Hospital

Linyi, 276002

China

Liuzhou people's Hospital

Liuzhou, 545006

China

Jiangxi Cancer Hospital

Nanchang, 330029

China

Jiangsu Cancer Hospital

Nanjing, 210009

China

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

Nanjing, 223800

China

Wuming Hospital of Guangxi Medical University

Nanning, 530000

China

The Cancer Hospital Affiliated to Guangxi Medical University

Nanning, 530021

China

The Affiliated Hospital of Medical College Qingdao University

Qingdao, 266003

China

Fudan University Shanghai Cancer Center

Shanghai, 200032

China

Liaoning Cancer Hospital and Institute

Shenyang, 110042

China

Peking University Shenzhen Hospital

Shenzhen, 518036

China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, 50011

China

Second Affiliated Hospital, SooChow University

Suzhou, 215004

China

Shanxi Provincial Cancer hospital

Taiyuan, 30013

China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, 300060

China

Union Hospital Tongji Medical College of Huazhong University of Science and Technology

Wuhan, 430022

China

Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology

Wuhan, 430030

China

Hubei Cancer Hospital

Wuhan, 430079

China

The first affiliated hospital of xiamen university

Xiamen, 361003

China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, 221000

China

Henan Cancer Hospital

Zhengzhou, 450008

China

The Fifth Affiliated Hospital Sun Yat Sen University

Zhuhai, 519000

China

Klinicki bolnicki centar Zagreb

Zagreb, 10000

Croatia

Fakultni nemocnice Olomouc

Olomouc, 779 00

Czechia

Nemocnice Bulovka

Prague, 180 81

Czechia

Tampereen Yliopistollinen Sairaala

Tampere, 33520

Finland

CHU Amiens Picardie

Amiens, 80000

France

CHU Brest

Brest, 29609

France

Centre Francois Baclesse

Caen, 14076

France

Centre Georges Francois Leclerc

Dijon, 21000

France

Centre de Lutte contre le Cancer Centre Oscar Lambret

Lille, 59020

France

Centre Leon Berard

Lyon, 69008

France

Hopital de la Timone

Marseille, 13385

France

Clinique Ambroise Pare

Neuilly-sur-Seine, 92200

France

Hopital Europeen Georges Pompidou

Paris, 75015

France

Institut Curie

Paris, 75248

France

Hopital Tenon

Paris, 75970

France

Hopital Haut Leveque

Pessac, 33604

France

Hopital Pontchaillou

Rennes, 35000

France

CLCC - Centre Henri Becquerel

Rouen, 76038

France

CHU Saint Etienne

Saint-Etienne, 42055

France

Centre Hospitalier de Valenciennes Hopital Jean Bernard

Valenciennes, 59322

France

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, 54500

France

Gustave Roussy

Villejuif, 94805

France

High Technology Hospital MedCenter Ltd Batumi

Batumi, 6000

Georgia

JSC Vian Kutaisi Referral Hospital

Kutaisi, 4600

Georgia

Todua Clinic

Tbilisi, 0112

Georgia

Ltd Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

Tbilisi, 144

Georgia

Universitaetsklinikum Giessen und Marburg GmbH

Giessen, 35392

Germany

Medizinische Hochschule Hannover

Hanover, 30625

Germany

Universitatsklinikum Jena

Jena, 07747

Germany

Klinikum rechts der Isar an der Technischen Universitat Munchen

München, 81675

Germany

Universitaetsmedizin Rostock

Rostock, 18059

Germany

University General Hospital Attikon General Hospital Of West Attica H Agia Varvara

Athens, 124 62

Greece

University Hospital Of Larissa

Larissa, 41110

Greece

Athens Medical Center S A Interbalkan Medical Center of Thessaloniki

Thessaloniki, 54639

Greece

Interbalkan Medical Center of Thessaloniki

Thessaloniki, 57001

Greece

Eszak Pesti Centrumkorhaz Honvedkorhaz

Budapest, 1062

Hungary

Orszagos Onkologiai Intezet

Budapest, 1122

Hungary

Szent Gyorgyi Albert Klinikai Kozpont Onkoterapias Klinika

Szeged, 6720

Hungary

M S Ramaiah Memorial Hospital

Bangalore, 560054

India

Apollo Speciality Hospital, Chennai

Chennai, 600035

India

Meenakshi Mission Hospital and Research Center

Madurai, 625107

India

Tata Memorial Hospital

Mumbai, 400012

India

HealthCare Global HCG Manavata Cancer Centre

Nashik, 422002

India

Rajiv Gandhi Cancer Institute and Research Centre

New Delhi, 110085

India

Grant Medical foundation Ruby Hall Clinic

Pune, 411 001

India

HCG cancer center

Vijayawada, 520002

India

Samson Assuta Ashdod University Hospital

Ashdod, 7747629

Israel

Rambam Health Care Campus

Haifa, 3109601

Israel

Hadassah Medical Center

Jerusalem, 9112001

Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906

Israel

Tokyo Medical and Dental University Hospital

Bunkyō City, 113-8519

Japan

Hiroshima University Hospital

Hiroshima, 734 8551

Japan

National Cancer Center Hospital East

Kashiwa, 277-8577

Japan

Aichi Cancer Center

Nagoya, 464-8681

Japan

Osaka International Cancer Institute

Osaka, 541 8567

Japan

Kindai University Hospital

Osaka Sayama Shi, 589 8511

Japan

Tohoku University Hospital

Sendai, 980 8574

Japan

Jichi Medical University Hospital

Shimotsuke, 329-0498

Japan

Tokyo Medical University Hospital

Shinjuku, 160 0023

Japan

Shizuoka Cancer Center

Sunto Gun, 411 8777

Japan

University of Perpetual Help Dalta Medical Center, Inc

Las Piñas, 1742

Philippines

Manila Doctors Hospital

Manila, 1000

Philippines

The Medical City

Pasig, 1600

Philippines

St. Luke's Medical Center

Quezon City, 1112

Philippines

Uls Braga - Hosp. Braga

Braga, 4710 243

Portugal

Uls Santa Maria - Hosp. Santa Maria

Lisbon, 1649 035

Portugal

Hosp. Cuf Descobertas

Lisbon, 1998050

Portugal

Uls Santo Antonio - Hosp. Santo Antonio

Porto, 4099-001

Portugal

Uls Gaia Espinho

Vila Nova de Gaia, 4434 502

Portugal

Institutul Oncologic Prof Dr Al Trestioreanu Bucuresti

Bucharest, 22328

Romania

Institute of Oncology and Radiology of Serbia

Belgrade, 11000

Serbia

Vojnomedicinska Akademija

Belgrade, 11000

Serbia

Institute of Oncology of Vojvodina

Kamenitz, 21204

Serbia

University Clinical Center Kragujevac

Kragujevac, 34000

Serbia

Severance Hospital Yonsei University Health System

Seoul, 03722

South Korea

Asan Medical Center

Seoul, 05505

South Korea

The Catholic University of Korea Seoul St Mary s Hospital

Seoul, 06591

South Korea

The Catholic university of Korea, St. Vincent's Hospital

Suwon, 16247

South Korea

Hosp. Univ. de Cruces

Barakaldo, 48903

Spain

Hosp Clinic de Barcelona

Barcelona, 08036

Spain

Hosp Univ Vall D Hebron

Barcelona, 8035

Spain

Instituto Catalan Deoncologia Hospital Duran I Reynals

L'Hospitalet de Llobregat, 08908

Spain

Hospitales Universitarios San Roque En Las Palmas de Gran Canaria Centro Oncologico Integral Canario

Las Palmas de Gran Canaria, 35001

Spain

Hosp. Univ. Lucus Augusti

Lugo, 27003

Spain

Hosp. Gral. Univ. Gregorio Maranon

Madrid, 28007

Spain

Hosp Univ Fund Jimenez Diaz

Madrid, 28040

Spain

Hosp. Univ. 12 de Octubre

Madrid, 28041

Spain

Hosp Univ Hm Sanchinarro

Madrid, 28050

Spain

Hosp Regional Univ de Malaga

Málaga, 29010

Spain

Hosp. de Navarra

Pamplona, 31008

Spain

Hosp. Univ. Marques de Valdecilla

Santander, 39008

Spain

Hosp. Virgen Del Rocio

Seville, 41013

Spain

Inst. Valenciano de Oncologia

Valencia, 46009

Spain

Hosp. Gral. Univ. Valencia

Valencia, 46014

Spain

Hosp. Clinico Univ. Lozano Blesa

Zaragoza, 50009

Spain

Sahlgrenska Universitetssjukhuset

Gothenburg, 41345

Sweden

National Cheng Kung University Hospital

Bei Qu, 704

Taiwan

Changhua Christian Hospital

Changhua, 500

Taiwan

Chang-Gung Memorial Hospital-Keelung

Keelung, 20442

Taiwan

Taichung Veterans General Hospital

Taichung, 40705

Taiwan

National Taiwan University Hospital

Taipei, 100

Taiwan

Western General Hospital

Edinburgh, EH4 2XU

United Kingdom

NHS Greater Glasgow and Clyde

Glasgow, G12 0YN

United Kingdom

The Royal Surrey County Hospital NHS Foundation Trust

Guildford, GU2 7XX

United Kingdom

The Royal Marsden NHS Trust

London, SW3 6JJ

United Kingdom

Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE7 7DN

United Kingdom

Nottingham City Hospital

Nottingham, NG5 1PB

United Kingdom