RecruitingPhase 3NCT04892173

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

Sponsor

Johnson & Johnson Enterprise Innovation Inc.

Enrollment

500 participants

Start Date

Dec 10, 2021

Study Type

INTERVENTIONAL

Conditions

Carcinoma, Squamous Cell

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

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new treatment approach for older or frail patients with locally advanced head and neck squamous cell cancer (cancers of the mouth, throat, or voice box) who cannot tolerate standard platinum chemotherapy. The study involves injecting a special nanoparticle (NBTXR3) directly into the tumor and then activating it with radiation, with or without the drug cetuximab. **You may be eligible if...** - You are 60 years old or older with squamous cell cancer of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx - Your cancer is at an advanced local stage (T3–T4 or T2 with significant lymph node involvement) - You are eligible for definitive radiation therapy but cannot receive standard platinum-based chemotherapy (due to kidney function, hearing loss, nerve damage, age 75+, or other criteria) - There is at least one tumor accessible for direct injection **You may NOT be eligible if...** - Your cancer originated in the nasopharynx, sinuses, salivary gland, thyroid, or is an unknown primary - Your cancer is at an early stage or has spread to distant organs (M1) - You have had prior treatment for head and neck cancer in the same area - You have had another cancer in the past 2 years - You have an active infection requiring antibiotics Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJNJ-90301900 (NBTXR3)

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

DRUGCetuximab

Solution for infusion

RADIATIONRadiation Therapy

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

Locations(190)

University of Alabama at Birmingham

Birmingham, Alabama, United States

City of Hope

Duarte, California, United States

University of California at San Diego Moores Cancer Center

La Jolla, California, United States

Memorial Radiation Oncology Medical Group Laguna Hills

Laguna Hills, California, United States

UCLA Hematology Oncology

Los Angeles, California, United States

Hoag Memorial Hospital

Newport Beach, California, United States

University of California San Francisco

San Francisco, California, United States

George Washington University Cancer Center

Washington D.C., District of Columbia, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

University of Kentucky Markey Cancer Center

Lexington, Kentucky, United States

Boston Medical Center

Boston, Massachusetts, United States

Christus St. Vincent Regional Cancer Center

Santa Fe, New Mexico, United States

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

New York, New York, United States

Richmond University Medical Center

Staten Island, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Atrium Health Levine Cancer Institute

Charlotte, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Oregon Health And Science University

Portland, Oregon, United States

University of Pennsylvania Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

University of Virginia

Charlottesville, Virginia, United States

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

Norfolk, Virginia, United States

Medizinische Universitat Graz

Graz, Austria

Ordensklinikum Linz GmbH Barmherzige Schwestern

Linz, Austria

Medizinische Universitaet Wien

Vienna, Austria

Cliniques Universitaires Saint Luc

Brussels, Belgium

Grand Hopital De Charleroi Site Les Viviers

Charleroi, Belgium

Universitair Ziekenhuis Leuven

Leuven, Belgium

Fundacao Pio Xii - Hospital De Cancer De Barretos

Barretos, Brazil

Nucleo de Ensino e Pesquisa do Instituto Mario Penna

Belo Horizonte, Brazil

Centro Regional Integrado de Oncologia CRIO

Fortaleza, Brazil

Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará

Fortaleza, Brazil

Fundacao Sao Francisco Xavier

Ipatinga, Brazil

Hospital Amaral Carvalho

Jaú, Brazil

Hospital do Cancer de Londrina

Londrina, Brazil

Irmandade da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil

Hospital Sao Lucas da PUCRS

Porto Alegre, Brazil

Hospital Nossa Senhora da Conceicao

Porto Alegre, Brazil

Grupo Oncoclinicas - Botafogo

Rio de Janeiro, Brazil

Ensino e Terapia de Inovacao Clinica AMO Etica

Salvador, Brazil

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, Brazil

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

São Paulo, Brazil

Hospital Sirio Libanes Sao Paulo

São Paulo, Brazil

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

Vitória, Brazil

MHAT Uni Hospital

Panagyurishte, Bulgaria

Specialized Hospital for Active Treatment in Oncology

Sofia, Bulgaria

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada

The Affiliated Hospital of Bengbu Medical College

Bengbu, China

Xiangya Hospital Central South University

Changsha, China

Hunan Cancer hospital

Changsha, China

Sichuan Cancer Hospital

Chengdu, China

Dongguan People s Hospital

Dongguan, China

Fujian Medical University Union Hospital

Fuzhou, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, China

Fujian Medical University Fujian Provincial Cancer Hospital

Fuzhou, China

The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, China

Guangzhou Medical University Affiliated Oncology Hospital

Guangzhou, China

Guangzhou First Municipal People's Hospital

Guangzhou, China

Qilu Hospital of Shandong University

Jinan, China

Shandong Cancer Hospital

Jinan, China

Linyi Cancer Hospital

Linyi, China

Liuzhou people's Hospital

Liuzhou, China

Jiangxi Cancer Hospital

Nanchang, China

Jiangsu Cancer Hospital

Nanjing, China

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

Nanjing, China

Wuming Hospital of Guangxi Medical University

Nanning, China

The Cancer Hospital Affiliated to Guangxi Medical University

Nanning, China

The Affiliated Hospital of Medical College Qingdao University

Qingdao, China

Fudan University Shanghai Cancer Center

Shanghai, China

Liaoning Cancer Hospital and Institute

Shenyang, China

Peking University Shenzhen Hospital

Shenzhen, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, China

Second Affiliated Hospital, SooChow University

Suzhou, China

Shanxi Provincial Cancer hospital

Taiyuan, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

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

Wuhan, China

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

Wuhan, China

Hubei Cancer Hospital

Wuhan, China

The first affiliated hospital of xiamen university

Xiamen, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, China

Henan Cancer Hospital

Zhengzhou, China

The Fifth Affiliated Hospital Sun Yat Sen University

Zhuhai, China

Klinicki bolnicki centar Zagreb

Zagreb, Croatia

Nemocnice Bulovka

Prague, Czechia

Tampereen Yliopistollinen Sairaala

Tampere, Finland

CHU Amiens Picardie

Amiens, France

CHU Brest

Brest, France

Centre Francois Baclesse

Caen, France

Centre Georges Francois Leclerc

Dijon, France

Centre de Lutte contre le Cancer Centre Oscar Lambret

Lille, France

Centre Leon Berard

Lyon, France

Hopital de la Timone

Marseille, France

Clinique Ambroise Pare

Neuilly-sur-Seine, France

Hopital Europeen Georges Pompidou

Paris, France

Institut Curie

Paris, France

Hopital Tenon

Paris, France

Hopital Haut Leveque

Pessac, France

Hopital Pontchaillou

Rennes, France

CLCC - Centre Henri Becquerel

Rouen, France

CHU Saint Etienne

Saint-Etienne, France

Centre Hospitalier de Valenciennes Hopital Jean Bernard

Valenciennes, France

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, France

Gustave Roussy

Villejuif, France

High Technology Hospital MedCenter Ltd Batumi

Batumi, Georgia

JSC Vian Kutaisi Referral Hospital

Kutaisi, Georgia

Todua Clinic

Tbilisi, Georgia

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

Tbilisi, Georgia

Universitaetsklinikum Giessen und Marburg GmbH

Giessen, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Universitatsklinikum Jena

Jena, Germany

Klinikum rechts der Isar an der Technischen Universitat Munchen

München, Germany

Universitaetsmedizin Rostock

Rostock, Germany

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

Athens, Greece

University Hospital Of Larissa

Larissa, Greece

Athens Medical Center S A Interbalkan Medical Center of Thessaloniki

Thessaloniki, Greece

Interbalkan Medical Center of Thessaloniki

Thessaloniki, Greece

Eszak Pesti Centrumkorhaz Honvedkorhaz

Budapest, Hungary

Orszagos Onkologiai Intezet

Budapest, Hungary

Szent Gyorgyi Albert Klinikai Kozpont Onkoterapias Klinika

Szeged, Hungary

M S Ramaiah Memorial Hospital

Bangalore, India

Apollo Speciality Hospital, Chennai

Chennai, India

Meenakshi Mission Hospital and Research Center

Madurai, India

Tata Memorial Hospital

Mumbai, India

HealthCare Global HCG Manavata Cancer Centre

Nashik, India

Rajiv Gandhi Cancer Institute and Research Centre

New Delh, India

Grant Medical foundation Ruby Hall Clinic

Pune, India

HCG cancer center

Vijayawada, India

Samson Assuta Ashdod University Hospital

Ashdod, Israel

Rambam Health Care Campus

Haifa, Israel

Hadassah Medical Center

Jerusalem, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Tokyo Medical and Dental University Hospital

Bunkyō City, Japan

Hiroshima University Hospital

Hiroshima, Japan

National Cancer Center Hospital East

Kashiwa, Japan

Aichi Cancer Center

Nagoya, Japan

Osaka International Cancer Institute

Osaka, Japan

Kindai University Hospital

Osaka Sayama Shi, Japan

Tohoku University Hospital

Sendai, Japan

Jichi Medical University Hospital

Shimotsuke, Japan

Tokyo Medical University Hospital

Shinjuku, Japan

Shizuoka Cancer Center

Sunto Gun, Japan

University of Perpetual Help Dalta Medical Center, Inc

Las Piñas, Philippines

Manila Doctors Hospital

Manila, Philippines

The Medical City

Pasig, Philippines

St. Luke's Medical Center

Quezon City, Philippines

Uls Braga - Hosp. Braga

Braga, Portugal

Uls Santa Maria - Hosp. Santa Maria

Lisbon, Portugal

Hosp. Cuf Descobertas

Lisbon, Portugal

Uls Santo Antonio - Hosp. Santo Antonio

Porto, Portugal

Uls Gaia Espinho

Vila Nova de Gaia, Portugal

Institutul Oncologic Prof Dr Al Trestioreanu Bucuresti

Bucharest, Romania

Institute of Oncology and Radiology of Serbia

Belgrade, Serbia

Vojnomedicinska Akademija

Belgrade, Serbia

Institute of Oncology of Vojvodina

Kamenitz, Serbia

University Clinical Center Kragujevac

Kragujevac, Serbia

Severance Hospital Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

The Catholic University of Korea Seoul St Mary s Hospital

Seoul, South Korea

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

Suwon, South Korea

Hosp. Univ. de Cruces

Barakaldo, Spain

Hosp Clinic de Barcelona

Barcelona, Spain

Hosp Univ Vall D Hebron

Barcelona, Spain

Instituto Catalan Deoncologia Hospital Duran I Reynals

L'Hospitalet de Llobregat, Spain

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

Las Palmas de Gran Canaria, Spain

Hosp. Univ. Lucus Augusti

Lugo, Spain

Hosp. Gral. Univ. Gregorio Maranon

Madrid, Spain

Hosp Univ Fund Jimenez Diaz

Madrid, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Hosp Univ Hm Sanchinarro

Madrid, Spain

Hosp Regional Univ de Malaga

Málaga, Spain

Hosp. de Navarra

Pamplona, Spain

Hosp. Univ. Marques de Valdecilla

Santander, Spain

Hosp. Virgen Del Rocio

Seville, Spain

Inst. Valenciano de Oncologia

Valencia, Spain

Hosp. Gral. Univ. Valencia

Valencia, Spain

Hosp. Clinico Univ. Lozano Blesa

Zaragoza, Spain

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

National Cheng Kung University Hospital

Bei Qu, Taiwan

Changhua Christian Hospital

Changhua, Taiwan

Chang-Gung Memorial Hospital-Keelung

Keelung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

The Royal Surrey County Hospital NHS Foundation Trust

Guildford, United Kingdom

The Royal Marsden NHS Foundation Trust

London, United Kingdom

Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, United Kingdom

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