JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
Launched by JOHNSON & JOHNSON ENTERPRISE INNOVATION INC. · May 13, 2021
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment option for elderly patients with locally advanced head and neck squamous cell carcinoma (a type of cancer in the head and neck region) who are not eligible for standard platinum-based chemotherapy. The trial is comparing a treatment called NBTXR3, which is given with radiation therapy, to radiation therapy alone, with some participants also receiving a medication called cetuximab. The goal is to see how effective these treatments are and to ensure they are safe for patients.
To be eligible for this trial, participants must be at least 65 years old and have a confirmed diagnosis of this type of cancer. They should also be unable to receive standard chemotherapy for specific health reasons. Participants will undergo treatments as determined by the study doctors and will be closely monitored for their health and treatment response. This trial is currently recruiting participants, and it is important for potential candidates to discuss their eligibility with their healthcare provider to understand if this study is a good option for them.
Gender
ALL
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
About Johnson & Johnson Enterprise Innovation Inc.
Johnson & Johnson Enterprise Innovation Inc. is a leading global healthcare company dedicated to advancing the science of health through innovative solutions. As a subsidiary of Johnson & Johnson, it focuses on harnessing cutting-edge technologies and collaborative strategies to drive breakthroughs in medical research and product development. The organization emphasizes patient-centric approaches, aiming to enhance health outcomes across diverse therapeutic areas. By fostering partnerships and leveraging its extensive expertise, Johnson & Johnson Enterprise Innovation Inc. is committed to delivering transformative healthcare solutions that address unmet medical needs and improve quality of life.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bronx, New York, United States
Belgrade, , Serbia
Pessac, , France
Paris, , France
Madrid, , Spain
Lyon, , France
Paris, , France
Duarte, California, United States
Tampa, Florida, United States
Staten Island, New York, United States
San Francisco, California, United States
Chapel Hill, North Carolina, United States
Villejuif, , France
Porto Alegre, , Brazil
Qingdao, , China
Taipei, , Taiwan
Mumbai, , India
Nanjing, , China
Changhua, , Taiwan
Rennes, , France
Nagoya, , Japan
Porto Alegre, , Brazil
Budapest, , Hungary
Newport Beach, California, United States
Taipei, , Taiwan
Brussels, , Belgium
Taichung, , Taiwan
Lyon, , France
Rennes, , France
Caen, , France
Paris, , France
Tampere, , Finland
Seoul, , Korea, Republic Of
Brest, , France
Paris, , France
Atlanta, Georgia, United States
Tel Aviv, , Israel
Santa Fe, New Mexico, United States
Sevilla, , Spain
Santander, , Spain
Ulm, , Germany
Suwon, , Korea, Republic Of
Belgrade, , Serbia
Sremska Kamenica, , Serbia
Shanghai, , China
Lisboa, , Portugal
Lugo, , Spain
Graz, , Austria
Wien, , Austria
Marseille, , France
Graz, , Austria
Quezon City, , Philippines
Budapest, , Hungary
Wien, , Austria
Madrid, , Spain
Olomouc, , Czechia
Manila, , Philippines
Hiroshima, , Japan
Leuven, , Belgium
Jinan, , China
Paris Cedex 5, , France
Valenciennes, , France
Marseille, , France
Jena, , Germany
Brussel, , Belgium
Seoul, , Korea, Republic Of
Caen Cedex 05, , France
Kashiwa, , Japan
Los Angeles, California, United States
Barcelona, , Spain
Neuilly Sur Seine, , France
Larissa, , Greece
Changsha, Hunan, China
Newcastle Upon Tyne, , United Kingdom
Shinjuku Ku, Tokyo, Japan
Pamplona, , Spain
Tianjin, , China
Tampere, , Finland
Oklahoma City, Oklahoma, United States
Zhengzhou, Henan, China
Shinjuku, , Japan
Bangalore, , India
Braga, , Portugal
Jena, , Germany
Guangzhou, , China
Sofia, , Bulgaria
Jinan, , China
Suwon, , Korea, Republic Of
Villejuif Cedex, , France
Wuhan, , China
Manila, Metro Manila, Philippines
Porto Alegre, Rio Grande Do Sul, Brazil
Tel Aviv, , Israel
Hanover, , Germany
Haifa, , Israel
Seoul, , Korea, Republic Of
Pessac, , France
Saint Nazaire, , France
Porto Alegre, Rio Grande Do Sul, Brazil
Glasgow, Scotland, United Kingdom
L'hospitalet De Llobregat, , Spain
Glasgow, , United Kingdom
Sendai Shi, , Japan
Xiamen, , China
Jerusalem, , Israel
Olomouc, , Czechia
Vandœuvre Lès Nancy, , France
Goteborg, , Sweden
Madrid, , Spain
Barakaldo, , Spain
Nanjing, , China
Madrid, , Spain
Pasig, Metro Manila, Philippines
Guildford, , United Kingdom
Lugo, , Spain
Chang Hua, , Taiwan
Linz, , Austria
Thessaloniki, , Greece
Goteborg, , Sweden
Suwon Si, , Korea, Republic Of
Kragujevac, , Serbia
Montréal, , Canada
Valencia, , Spain
Madrid, , Spain
Santander, , Spain
London, England, United Kingdom
Paris, , France
Osaka, , Japan
Chengdu, Sichuan, China
Cologne, , Germany
Changsha, , China
Sevilla, , Spain
Larissa, , Greece
Amiens, , France
Zagreb, , Croatia
Vandoeuvre Les Nancy, , France
Xuzhou, Jiangsu, China
Hunan, , China
Tianjin, , China
Fuzhou, , China
Barakaldo, , Spain
São José Do Rio Preto, , Brazil
Barcelona, , Spain
Belgrade, , Serbia
Saint étienne, , France
Giessen, , Germany
Pamplona, , Spain
Valencia, , Spain
Shimotsuke, , Japan
Wuhan, , China
Fortaleza, , Brazil
Ashdod, , Israel
Batumi, , Georgia
Madhurai, , India
Hubei, , China
Shandong, , China
Fujian, , China
Tainan, , Taiwan
Shenyang, , China
Barretos, , Brazil
Amiens, , France
Tampa, Florida, United States
Leuven, , Belgium
Panagyurishte, , Bulgaria
Sofia, , Bulgaria
Lille, , France
Tbilisi, , Georgia
Tbilisi, , Georgia
Shijiazhuang, , China
Bengbu, , China
Jiangxi, , China
Bunkyo, , Japan
Pasig, , Philippines
Zagreb, , Croatia
Chapel Hill, North Carolina, United States
Linz, , Austria
Fujian, , China
Guandong, , China
Guandong, , China
Guangdong, , China
Guangxi, , China
Hubei, , China
Jiangxi, , China
Jiangxi, , China
Shandong, , China
Shandong, , China
Shanxi, , China
Prague, , Czechia
Brest, , France
Paris, , France
Rouen, , France
Kutaisi, , Georgia
Gießen, , Germany
Munich, , Germany
Rostock, , Germany
Attikí, , Greece
Thessaloníki, , Greece
Budapest, , Hungary
Szeged, , Hungary
Ashdod, , Israel
Ramat Gan, , Israel
Osaka, , Japan
Lisboa, , Portugal
Santarém, , Portugal
Bucharest, , Romania
Belgrade, , Serbia
Sremska Kamenica, , Serbia
Sumadija, , Serbia
Panagyurishte, , Bulgaria
Valencia, , Spain
Liuzhou, , China
Sao Paulo, , Brazil
Budapest, , Hungary
München, , Germany
Sendai Shi, Miyagi, Japan
Osaka Sayama Shi, , Japan
Hiroshima Shi, , Japan
New York, New York, United States
Seoul, , Korea, Republic Of
Barcelona, , Spain
Madrid, , Spain
Barcelona, , Spain
Madrid, , Spain
Málaga, , Spain
Shen Zhen Shi, , China
Osaka, , Japan
Lisboa, , Portugal
Wuhan, , China
Suwon Si, , Korea, Republic Of
Vila Nova De Gaia, , Portugal
Tbilisi, , Georgia
Long Beach, California, United States
Newport Beach, California, United States
Santa Fe, New Mexico, United States
New York, New York, United States
Oklahoma City, Oklahoma, United States
Gilly, Hainaut, Belgium
Fortaleza, Ceara, Brazil
Fortaleza, Ceara, Brazil
Belo Horizonte, Minas Gerais, Brazil
Ijui, Rio Grande Do Sul, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Barretos, Sao Paulo, Brazil
Jau, Sao Paulo, Brazil
São José Do Rio Preto, Sao Paulo, Brazil
Rio De Janeiro, , Brazil
Sao Paulo, , Brazil
Bangalore, Karnataka, India
Mumbai, Maharashtra, India
Pune, Maharashtra, India
Madurai, Tamil Nadu, India
Chennai, , India
Nashik, , India
Nagoya, Aiti [Aichi], Japan
Shizuoka, Sizuoka [Shizuoka], Japan
Kashiwa Shi, Tiba [Chiba], Japan
Shimotsuke City, Totigi, Japan
Tokyo, , Japan
Las Pinas, Metropolitan Manila, Philippines
Quezon City, Metropolitan Manila, Philippines
Porto, , Portugal
Vila Nova De Gaia, , Portugal
Las Palmas, , Spain
Malaga, , Spain
Valencia, , Spain
Guildford, England, United Kingdom
Newcastle Upon Tyne, England, United Kingdom
Fu Zhou Shi, , China
Porto, , Portugal
Sunto Gun, , Japan
Tbilisi, , Georgia
Braga, , Portugal
Laguna Hills, California, United States
Gilly, , Belgium
Belo Horizonte, , Brazil
Fortaleza, , Brazil
Jau, , Brazil
Rio De Janeiro, , Brazil
Sao Paulo, , Brazil
Dongguan, , China
Fuzhou, , China
Guangzhou, , China
Guangzhou, , China
Linyi, , China
Nanchang, , China
Nanning, , China
Nanning, , China
Suzhou, , China
Taiyuan, , China
Zhuhai, , China
Praha 8, , Czechia
Lille Cedex, , France
Rouen Cedex 1, , France
Saint Etienne Cedex 2, , France
Valenciennes Cedex, , France
Batumi, , Georgia
Kutaisi, , Georgia
Rostock, , Germany
Athens, , Greece
Szeged, , Hungary
Chennai, , India
Nashik, , India
Pune, , India
Seoul, , Korea, Republic Of
Las Pinas, , Philippines
Bucuresti, , Romania
L Hospitalet De Llobregat, , Spain
Las Palmas De Gran Canaria, , Spain
Valencia, , Spain
Bei Qu, , Taiwan
Keelung, , Taiwan
Shinjuku, , Japan
Patients applied
Trial Officials
Johnson & Johnson Enterprise Innovation Inc Clinical trial
Study Director
Johnson & Johnson Enterprise Innovation Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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