RecruitingCarcinoma, Squamous Cell

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

Eligible age

60+ yrs

Accepts

All genders

Locations

15 states

Healthy volunteers

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About this study

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).

Sponsor: Johnson & Johnson Enterprise Innovation Inc.

You may qualify if…

✓ 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,

You may not qualify if…

✕ 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