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

a study on Squamous Cell Carcinoma Head and Neck Cancer Head and Neck Squamous Cell Carcinoma

Summary

Eligibility
for people ages 60 years and up (full criteria)
Location
at La Jolla, California and other locations
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
  • Memorial Radiation Oncology Medical Group Laguna Hills completed
    Laguna Hills California 92653 United States
  • UCLA Hematology Oncology accepting new patients
    Los Angeles California 90095 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
Contact us about this trial