Clinical trial NCT04892173: JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma
Aged
Keywords: LA-HNSCC
NBTXR3
hafnium oxide
radioenhancer
Radiotherapy
RT
HNSCC
radiation therapy
Lead sponsor: Johnson & Johnson Enterprise Innovation Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-19
Enrollment: 500
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to (\>=) 60 years old
* 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), Grade \>= 2 hearing loss or tinnitus, Grade \>= 2 peripheral neuropathy, Eastern Cooperative Oncology Group (ECOG) Performance Status 2 or New York Heart Association Class 3
  2. Age 70-74 years old with Geriatric 8 (G8) score less than or equal to (\<=) 14
  3. Age \>= 75 years old

Exclusion Criteria:

* Carcinoma of the nasopharynx, paranasal sinus(es), salivary gland, thyroid gland, or unknown primary
* Non-squamous cell histology
* 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

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: 30 months following first randomized participant
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 48 months following first randomized participant
measure: Local-regional control
timeFrame: 48 months following first randomized participant
measure: Distant control
timeFrame: 48 months following first randomized participant
measure: Objective Response Rate (ORR)
timeFrame: 48 months following first randomized participant
measure: Duration of Overall Response
timeFrame: 48 months following first randomized participant
measure: Quality of Life over time - QLQ H&N35
timeFrame: 48 months following first randomized participant
measure: Quality of Life over time - EQ 5D 5L
timeFrame: 48 months following first randomized participant
measure: Safety across duration of study - AEs
timeFrame: 48 months following first randomized participant
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Laguna Hills
country: United States
facility: Memorial Radiation Oncology Medical Group Laguna Hills
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology Oncology
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Santa Fe
country: United States
facility: Christus St. Vincent Regional Cancer Center
state: New Mexico
city: New York
country: United States
facility: Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
state: New York
city: Staten Island
country: United States
facility: Richmond University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Barmherzige Schwestern
city: Wien
country: Austria
facility: Medizinische Universitaet Wien
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Gilly
country: Belgium
facility: Grand Hôpital de Charleroi - Site Saint-Joseph
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Barretos
country: Brazil
facility: Fundacao Pio Xii - Hospital De Cancer De Barretos
city: Belo Horizonte
country: Brazil
facility: Nucleo de Ensino e Pesquisa do Instituto Mario Penna
city: Fortaleza
country: Brazil
facility: Centro Regional Integrado de Oncologia CRIO
city: Fortaleza
country: Brazil
facility: Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará
city: Jau
country: Brazil
facility: Hospital Amaral Carvalho
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao
city: Rio De Janeiro
country: Brazil
facility: Grupo Oncoclinicas - Botafogo
city: Sao Paulo
country: Brazil
facility: Hospital Sirio Libanes Sao Paulo
city: Sao Paulo
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre
city: São José do Rio Preto
country: Brazil
facility: Hospital de Base de Sao Jose do Rio Preto
city: Panagyurishte
country: Bulgaria
facility: MHAT Uni Hospital
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment in Oncology
city: Bengbu
country: China
facility: The Affiliated Hospital of Bengbu Medical College
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: ChangSha
country: China
facility: Hunan Cancer hospital
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
city: Dongguan
country: China
facility: Dongguan People s Hospital
city: Fu Zhou Shi
country: China
facility: Fujian Medical University Union Hospital
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
city: Fuzhou
country: China
facility: Fujian Medical University Fujian Provincial Cancer Hospital
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangdong Pharmaceutical University
city: Guangzhou
country: China
facility: Guangzhou Medical University Affiliated Oncology Hospital
city: Guangzhou
country: China
facility: Guangzhou First Municipal People's Hospital
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
city: Jinan
country: China
facility: Shandong Cancer Hospital
city: Linyi
country: China
facility: Linyi Cancer Hospital
city: Liuzhou
country: China
facility: Liuzhou people's Hospital
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
city: Nanning
country: China
facility: Wuming Hospital of Guangxi Medical University
city: Nanning
country: China
facility: The Cancer Hospital Affiliated to Guangxi Medical University
city: Qingdao
country: China
facility: The Affiliated Hospital of Medical College Qingdao University
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shen Zhen Shi
country: China
facility: Peking University Shenzhen Hospital
city: Shenyang
country: China
facility: Liaoning Cancer Hospital and Institute
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
city: Suzhou
country: China
facility: Second Affiliated Hospital, SooChow University
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer hospital
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College of Huazhong University of Science and Technology
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
city: Wuhan
country: China
facility: Hubei Cancer Hospital
city: Xiamen
country: China
facility: The first affiliated hospital of xiamen university
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital Sun Yat Sen University
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar Zagreb
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Praha 8
country: Czechia
facility: Nemocnice Bulovka
city: Tampere
country: Finland
facility: Tampereen Yliopistollinen Sairaala
city: Amiens
country: France
facility: CHU Amiens Picardie
city: Brest
country: France
facility: CHU Brest
city: Caen Cedex 05
country: France
facility: Centre Francois Baclesse
city: Lille Cedex
country: France
facility: Centre de Lutte contre le Cancer Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Hopital de la Timone
city: Neuilly Sur Seine
country: France
facility: Clinique Ambroise Pare
city: PARIS Cedex 5
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Paris
country: France
facility: Hopital Tenon
city: Pessac
country: France
facility: Hopital Haut Leveque
city: Rennes
country: France
facility: Hopital Pontchaillou
city: Rouen Cedex 1
country: France
facility: CLCC - Centre Henri Becquerel
city: Saint Etienne Cedex 2
country: France
facility: CHU Saint Etienne
city: Valenciennes cedex
country: France
facility: Centre Hospitalier de Valenciennes Hopital Jean Bernard
city: Vandoeuvre les Nancy
country: France
facility: Institut de Cancerologie de Lorraine
city: Villejuif Cedex
country: France
facility: Gustave Roussy
city: Batumi
country: Georgia
facility: High Technology Hospital MedCenter Ltd Batumi
city: Kutaisi
country: Georgia
facility: JSC Vian Kutaisi Referral Hospital
city: Tbilisi
country: Georgia
facility: Todua Clinic
city: Tbilisi
country: Georgia
facility: Ltd Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
city: Giessen
country: Germany
facility: Universitaetsklinikum Giessen und Marburg GmbH
city: Jena
country: Germany
facility: Universitatsklinikum Jena
city: München
country: Germany
facility: Klinikum rechts der Isar an der Technischen Universitat Munchen
city: Rostock
country: Germany
facility: Universitaetsmedizin Rostock
city: Athens
country: Greece
facility: General Hospital of Athens Attikon
city: Larissa
country: Greece
facility: University Hospital Of Larissa
city: Thessaloniki
country: Greece
facility: Interbalkan Medical Center of Thessaloniki
city: Budapest
country: Hungary
facility: Eszak Pesti Centrumkorhaz Honvedkorhaz
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Szeged
country: Hungary
facility: Szent Gyorgyi Albert Klinikai Kozpont Onkoterapias Klinika
city: Bangalore
country: India
facility: M S Ramaiah Memorial Hospital
city: Chennai
country: India
facility: Apollo Speciality Hospital, Chennai
city: Madhurai
country: India
facility: Meenakshi Mission Hospital and Research Center
city: Mumbai
country: India
facility: Tata Memorial Hospital
city: Nashik
country: India
facility: HealthCare Global HCG Manavata Cancer Centre
city: Pune
country: India
facility: Grant Medical foundation Ruby Hall Clinic
city: Ashdod
country: Israel
facility: Samson Assuta Ashdod University Hospital
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Bunkyo
country: Japan
facility: Tokyo Medical and Dental University Hospital
city: Hiroshima shi
country: Japan
facility: Hiroshima University Hospital
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
city: Nagoya
country: Japan
facility: Aichi Cancer Center
city: Osaka Sayama shi
country: Japan
facility: Kindai University Hospital
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Sendai-Shi
country: Japan
facility: Tohoku University Hospital
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
city: Shinjuku
country: Japan
facility: Tokyo Medical University Hospital
city: Sunto Gun
country: Japan
facility: Shizuoka Cancer Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Mary s Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center (AMC)
city: Suwon si
country: Korea, Republic of
facility: The Catholic university of Korea, St. Vincent's Hospital
city: Suwon si
country: Korea, Republic of
facility: Ajou University Hospital
city: Las Pinas
country: Philippines
facility: University of Perpetual Help Dalta Medical Center, Inc
city: Manila
country: Philippines
facility: Manila Doctors Hospital
city: Pasig
country: Philippines
facility: The Medical City
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center
city: Braga
country: Portugal
facility: Uls Braga - Hosp. Braga
city: Lisboa
country: Portugal
facility: Uls Santa Maria - Hosp. Santa Maria
city: Lisboa
country: Portugal
facility: Hosp. Cuf Descobertas
city: Porto
country: Portugal
facility: Uls Santo Antonio - Hosp. Santo Antonio
city: Vila Nova de Gaia
country: Portugal
facility: Uls Gaia Espinho
city: Bucuresti
country: Romania
facility: Institutul Oncologic Prof Dr Al Trestioreanu Bucuresti
city: Belgrade
country: Serbia
facility: Institute of Oncology and Radiology of Serbia
city: Belgrade
country: Serbia
facility: Vojnomedicinska Akademija
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac
city: Sremska Kamenica
country: Serbia
facility: Institute of Oncology of Vojvodina
city: Barakaldo
country: Spain
facility: Hosp. Univ. de Cruces
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: L Hospitalet De Llobregat
country: Spain
facility: Instituto Catalan Deoncologia Hospital Duran I Reynals
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospitales Universitarios San Roque En Las Palmas de Gran Canaria Centro Oncologico Integral Canario
city: Lugo
country: Spain
facility: Hosp. Univ. Lucus Augusti
city: Madrid
country: Spain
facility: Hosp Univ Fund Jimenez Diaz
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Madrid
country: Spain
facility: Hosp Univ Hm Sanchinarro
city: Málaga
country: Spain
facility: Hosp Regional Univ de Malaga
city: Pamplona
country: Spain
facility: Hosp. de Navarra
city: Santander
country: Spain
facility: Hosp. Univ. Marques de Valdecilla
city: Sevilla
country: Spain
facility: Hosp. Virgen Del Rocio
city: Valencia
country: Spain
facility: Inst. Valenciano de Oncologia
city: Valencia
country: Spain
facility: Hosp. Gral. Univ. Valencia
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Bei Qu
country: Taiwan
facility: National Cheng Kung University Hospital
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Keelung
country: Taiwan
facility: Chang-Gung Memorial Hospital-Keelung
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
city: Guildford
country: United Kingdom
facility: The Royal Surrey County Hospital NHS Foundation Trust
city: Newcastle upon Tyne
country: United Kingdom
facility: Newcastle upon Tyne Hospitals NHS Foundation Trust
Study officials:
affiliation: Johnson & Johnson Enterprise Innovation Inc.
name: Johnson & Johnson Enterprise Innovation Inc Clinical trial
role: STUDY_DIRECTOR
References: