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

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

Summary

Eligibility
for people ages 60 years and up (full criteria)
Location
at UCSF
Dates
study started
completion 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 LA-HNSCC

Details

Participants will undergo a screening assessment over a period of less than or equal to (<=) 28 days to determine eligibility.

Eligible participants will be treated by the Investigator's choice of RT alone or RT in combination with cetuximab. Following the Investigator's choice, participants will be randomized in a 1:1 ratio:

  • Arm A: JNJ-90301900 (NBTXR3), as an intratumoral/intranodal injection, activated by investigator's choice of RT alone or RT in combination with cetuximab
  • Arm B: Investigator's choice of RT alone or RT in combination with cetuximab

All participants (Arm A and Arm B) will receive 70 Gy in 35 fractions over a 7 week period.

An EOT visit will be performed 4 weeks after the completion of RT. Follow-up visits will start at 12 weeks post-RT completion, and will continue every 12 weeks for 2 years, and then every 24 weeks thereafter until death; the participant is determined to be lost to follow up; withdrawal of consent; or the end of the study, whichever occurs first. Participants who have received further anti-cancer therapy for the study disease and/or have had disease progression/recurrence will be followed only for survival information

Keywords

Locally Advanced Head and Neck Squamous Cell Carcinoma, Aged, LA-HNSCC, NBTXR3, hafnium oxide, radioenhancer, Radiotherapy, RT, HNSCC, radiation therapy, 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
  • 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), Grade >= 2 hearing loss or tinnitus, Grade >= 2 peripheral neuropathy, Eastern Cooperative Oncology Group (ECOG) Performance Status 2 or New York Heart Association Class 3
    2. Age 70-74 years old with Geriatric 8 (G8) score less than or equal to (<=) 14
    3. Age >= 75 years old

You CAN'T join if...

  • Carcinoma of the nasopharynx, paranasal sinus(es), salivary gland, thyroid gland, or unknown primary
  • Non-squamous cell histology
  • 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 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 accepting new patients
    Laguna Hills California 92653 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