Summary

Eligibility
for people ages 60 years and up (full criteria)
Location
at UCLA UCSD UCSF
Dates
study started
study ends around

Description

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).

Official Title

A Phase 3 Study of NBTXR3 Activated by Investigator's Choice of Radiotherapy Alone or Radiotherapy in Combination With Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients With Locally Advanced Head & Neck Squamous Cell Carcinoma

Keywords

Carcinoma, Squamous Cell, LA-HNSCC, NBTXR3, hafnium oxide, radioenhancer, Radiotherapy, RT, HNSCC, radiation therapy, Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, Cetuximab, JNJ-90301900 (NBTXR3)

Eligibility

You can join if…

Open to people ages 60 years and up

  • 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

You CAN'T join 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

Locations

  • University of California at San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • UCLA Hematology Oncology accepting new patients
    Los Angeles California 90095 United States
  • University of California San Francisco accepting new patients
    San Francisco California 94158 United States
  • Hoag Memorial Hospital accepting new patients
    Newport Beach California 92663 United States
  • Memorial Radiation Oncology Medical Group Laguna Hills completed
    Laguna Hills California 92653 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Johnson & Johnson Enterprise Innovation Inc.
ID
NCT04892173
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 500 study participants
Last Updated