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Trial NCT04892173

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

Phase
Phase 3
Sponsor
Johnson & Johnson Enterprise Innovation Inc.
Conditions
Carcinoma, Squamous Cell
Ages
60+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

Inclusion Criteria: * Age greater than or equal to (>=) 60 years oldAge * 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),Renal 2. Grade >= 2 hearing loss or tinnitus, 3. Grade >= 2 peripheral neuropathy, 4. New York Heart Association Class 3Cardiac 5. Aged 70-74 years old with Geriatric 8 (G8) score less than or equal to (<=) 14 or Aged >= 75 years old * Eastern cooperative oncology group (ECOG) performance status 0 to 1Performance status * Life expectancy >= 6 months Exclusion Criteria: * 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 agentPrior malignancy * Ongoing or active infection requiring treatment with antimicrobial therapy within 2 weeks of randomization

Restrictions found (5)

Recruiting in Massachusetts

  • Boston Medical Center · Boston, Suffolk County