JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
- Conditions
- Locally Advanced Head and Neck Squamous Cell CarcinomaAged
- Interventions
- Registration Number
- NCT04892173
- Lead Sponsor
- Johnson & Johnson Enterprise Innovation Inc.
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
-
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):
- 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
- Age 70-74 years old with Geriatric 8 (G8) score less than or equal to (<=) 14
- Age >= 75 years old
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 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. Arm A Cetuximab 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. Arm A Radiation Therapy 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. Arm B Cetuximab Investigator's choice of RT alone or RT in combination with cetuximab. Arm B Radiation Therapy Investigator's choice of RT alone or RT in combination with cetuximab.
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) 30 months following first randomized participant Time from randomization to local-regional recurrence, local-regional progression, distant progression, or death from any cause, whichever occurs first
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) 48 months following first randomized participant Time from randomization to death from any cause
Local-regional control 48 months following first randomized participant Time to local regional progression: time from Randomization to local-regional progression or death, whichever occurs first
Quality of Life over time - EQ 5D 5L 48 months following first randomized participant Change from baseline over time in symptoms, function, and health related QOL using the 5 level EuroQol 5 dimension (EQ 5D 5L) instrument
Safety across duration of study - AEs 48 months following first randomized participant Adverse events (AEs)
Distant control 48 months following first randomized participant Time to distant progression: time from Randomization to distant progression or death, whichever occurs first
Objective Response Rate (ORR) 48 months following first randomized participant Rate of complete response (CR)+partial response (PR) \[RESIST 1.1\]
Duration of Overall Response 48 months following first randomized participant Time from CR or PR to progression of disease, unequivocal clinical progression, or death, whichever occurs first
Quality of Life over time - QLQ H&N35 48 months following first randomized participant 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)
Trial Locations
- Locations (159)
Apollo Speciality Hospital, Chennai
🇮🇳Chennai, India
Meenakshi Mission Hospital and Research Center
🇮🇳Madhurai, India
Hosp. Gral. Univ. Valencia
🇪🇸Valencia, Spain
Szent Gyorgyi Albert Klinikai Kozpont Onkoterapias Klinika
🇭🇺Szeged, Hungary
M S Ramaiah Memorial Hospital
🇮🇳Bangalore, India
The Affiliated Hospital of Medical College Qingdao University
🇨🇳Qingdao, China
Eszak Pesti Centrumkorhaz Honvedkorhaz
🇭🇺Budapest, Hungary
Hospitales Universitarios San Roque En Las Palmas de Gran Canaria Centro Oncologico Integral Canario
🇪🇸Las Palmas de Gran Canaria, Spain
Hosp. de Navarra
🇪🇸Pamplona, Spain
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
Moffitt Cancer Center
🇺🇸Tampa, Florida, 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
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
Medizinische Universität Graz
🇦🇹Graz, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern
🇦🇹Linz, Austria
Medizinische Universitaet Wien
🇦🇹Wien, Austria
Cliniques Universitaires Saint Luc
🇧🇪Brussels, Belgium
Grand Hôpital de Charleroi - Site Saint-Joseph
🇧🇪Gilly, 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
Orszagos Onkologiai Intezet
🇭🇺Budapest, Hungary
Centro Regional Integrado de Oncologia CRIO
🇧🇷Fortaleza, Brazil
Hospital Amaral Carvalho
🇧🇷Jau, Brazil
Hospital Sao Lucas da PUCRS
🇧🇷Porto Alegre, Brazil
Hospital Nossa Senhora da Conceicao
🇧🇷Porto Alegre, Brazil
Grupo Oncoclinicas - Botafogo
🇧🇷Rio De Janeiro, Brazil
Hospital Sirio Libanes Sao Paulo
🇧🇷Sao Paulo, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
🇧🇷Sao Paulo, Brazil
Hospital de Base de Sao Jose do Rio Preto
🇧🇷São José do Rio Preto, Brazil
MHAT Uni Hospital
🇧🇬Panagyurishte, Bulgaria
Specialized Hospital for Active Treatment in Oncology
🇧🇬Sofia, Bulgaria
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
🇨🇳Fu Zhou Shi, 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
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China
Peking University Shenzhen Hospital
🇨🇳Shen Zhen Shi, China
Liaoning Cancer Hospital and Institute
🇨🇳Shenyang, 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
Fakultni nemocnice Olomouc
🇨🇿Olomouc, Czechia
Nemocnice Bulovka
🇨🇿Praha 8, Czechia
Tampereen Yliopistollinen Sairaala
🇫🇮Tampere, Finland
CHU Amiens Picardie
🇫🇷Amiens, France
CHU Brest
🇫🇷Brest, France
Centre Francois Baclesse
🇫🇷Caen Cedex 05, France
Centre de Lutte contre le Cancer Centre Oscar Lambret
🇫🇷Lille Cedex, France
Centre Leon Berard
🇫🇷Lyon, France
Hopital de la Timone
🇫🇷Marseille, France
Clinique Ambroise Pare
🇫🇷Neuilly Sur Seine, France
Institut Curie
🇫🇷PARIS Cedex 5, France
Hopital Europeen Georges Pompidou
🇫🇷Paris, France
Hopital Tenon
🇫🇷Paris, France
Hopital Haut Leveque
🇫🇷Pessac, France
Hopital Pontchaillou
🇫🇷Rennes, France
CLCC - Centre Henri Becquerel
🇫🇷Rouen Cedex 1, France
CHU Saint Etienne
🇫🇷Saint Etienne Cedex 2, France
Centre Hospitalier de Valenciennes Hopital Jean Bernard
🇫🇷Valenciennes cedex, France
Institut de Cancerologie de Lorraine
🇫🇷Vandoeuvre les Nancy, France
Gustave Roussy
🇫🇷Villejuif Cedex, 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
Universitatsklinikum Jena
🇩🇪Jena, Germany
Klinikum rechts der Isar an der Technischen Universitat Munchen
🇩🇪München, Germany
Universitaetsmedizin Rostock
🇩🇪Rostock, Germany
General Hospital of Athens Attikon
🇬🇷Athens, Greece
University Hospital Of Larissa
🇬🇷Larissa, Greece
Interbalkan Medical Center of Thessaloniki
🇬🇷Thessaloniki, Greece
Tata Memorial Hospital
🇮🇳Mumbai, India
HealthCare Global HCG Manavata Cancer Centre
🇮🇳Nashik, India
Grant Medical foundation Ruby Hall Clinic
🇮🇳Pune, 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
🇯🇵Bunkyo, Japan
Hiroshima University Hospital
🇯🇵Hiroshima shi, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa, Japan
Aichi Cancer Center
🇯🇵Nagoya, Japan
Kindai University Hospital
🇯🇵Osaka Sayama shi, Japan
Osaka International Cancer Institute
🇯🇵Osaka, Japan
Tohoku University Hospital
🇯🇵Sendai-Shi, Japan
Jichi Medical University Hospital
🇯🇵Shimotsuke, Japan
Tokyo Medical University Hospital
🇯🇵Shinjuku, Japan
Shizuoka Cancer Center
🇯🇵Sunto Gun, Japan
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Seoul St Mary s Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center (AMC)
🇰🇷Seoul, Korea, Republic of
The Catholic university of Korea, St. Vincent's Hospital
🇰🇷Suwon si, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon si, Korea, Republic of
University of Perpetual Help Dalta Medical Center, Inc
🇵🇭Las Pinas, 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
Hosp. Cuf Descobertas
🇵🇹Lisboa, Portugal
Uls Gaia Espinho
🇵🇹Vila Nova de Gaia, Portugal
Institutul Oncologic Prof Dr Al Trestioreanu Bucuresti
🇷🇴Bucuresti, Romania
Institute of Oncology and Radiology of Serbia
🇷🇸Belgrade, Serbia
Vojnomedicinska Akademija
🇷🇸Belgrade, Serbia
University Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
Institute of Oncology of Vojvodina
🇷🇸Sremska Kamenica, Serbia
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
Hosp. Univ. Lucus Augusti
🇪🇸Lugo, 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. Univ. Marques de Valdecilla
🇪🇸Santander, Spain
Hosp. Virgen Del Rocio
🇪🇸Sevilla, Spain
Inst. Valenciano de Oncologia
🇪🇸Valencia, Spain
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
Newcastle upon Tyne Hospitals NHS Foundation Trust
🇬🇧Newcastle upon Tyne, United Kingdom