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

Purpose

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).

Condition

  • Carcinoma, Squamous Cell

Eligibility

Eligible Ages
Over 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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, 4. New York Heart Association Class 3 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 1 - 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 agent - Ongoing or active infection requiring treatment with antimicrobial therapy within 2 weeks of randomization

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Drug: JNJ-90301900 (NBTXR3)
    Suspension of inert, crystalline hafnium oxide particles, designed to generate oxygen free radicals to destroy cancer cells after activation by ionizing radiation.
    Other names:
    • Functionalized hafnium oxide nanoparticles
    • NBTXR3
  • Drug: Cetuximab
    Solution for infusion
    Other names:
    • Erbitux
  • Radiation: Radiation Therapy
    Intensity-modulated radiation therapy (IMRT): 70 Gray in 35 fractions over a 7-week period.
Active Comparator
Arm B: RT alone or RT in combination with cetuximab 		Investigator's choice of RT alone or RT in combination with cetuximab.
  • Drug: Cetuximab
    Solution for infusion
    Other names:
    • Erbitux
  • Radiation: Radiation Therapy
    Intensity-modulated radiation therapy (IMRT): 70 Gray in 35 fractions over a 7-week period.

Recruiting Locations

Boston Medical Center
Boston, Massachusetts 02118

More Details

Status
Recruiting
Sponsor
Johnson & Johnson Enterprise Innovation Inc.

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com