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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Suspension of inert, crystalline hafnium oxide particles, designed to generate oxygen free radicals to destroy cancer cells after activation by ionizing radiation.
Solution for infusion
Intensity-modulated radiation therapy (IMRT): 70 Gray in 35 fractions over a 7-week period.
Progression-free Survival (PFS) Based on Independent Central Review (ICR)
PFS is defined as time from randomization to local-regional progression (including recurrence), distant progression, or death from any cause, whichever occurs first.
Time frame: 30 months following first randomized participant
Overall Survival (OS)
Time from randomization to death from any cause.
Time frame: 48 months following first randomized participant
Local-regional control
Time to local regional progression: time from randomization to local-regional progression (including recurrence) or death, whichever occurs first.
Time frame: 48 months following first randomized participant
Distant control
Time to distant progression: time from randomization to distant progression or death, whichever occurs first.
Time frame: 48 months following first randomized participant
Quality of Life over time - QLQ H&N35
Change from baseline over time in symptoms, function, and health related QOL using the European organisation for research and treatment of cancer (EORTC) questionnaire-head and neck cancer module (QLQ H\&N35).
Time frame: 48 months following first randomized participant
Quality of Life over time - EQ 5D 5L
Change from baseline over time in symptoms, function, and health related QOL using the 5 level EuroQol 5 dimension (EQ 5D 5L) instrument.
Time frame: 48 months following first randomized participant
Safety across duration of study - AEs
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University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGCity of Hope
Duarte, California, United States
RECRUITINGUniversity of California at San Diego Moores Cancer Center
La Jolla, California, United States
RECRUITINGMemorial Radiation Oncology Medical Group Laguna Hills
Laguna Hills, California, United States
COMPLETEDUCLA Hematology Oncology
Los Angeles, California, United States
RECRUITINGHoag Memorial Hospital
Newport Beach, California, United States
COMPLETEDUniversity of California San Francisco
San Francisco, California, United States
RECRUITINGGeorge Washington University Cancer Center
Washington D.C., District of Columbia, United States
RECRUITINGMayo Clinic Jacksonville
Jacksonville, Florida, United States
RECRUITINGAdventHealth Orlando
Orlando, Florida, United States
RECRUITING...and 183 more locations
Adverse events (AEs).
Time frame: 48 months following first randomized participant
Objective Response Rate (ORR)
Rate of complete response (CR)+partial response (PR) \[RESIST 1.1\].
Time frame: 48 months following first randomized participant
Duration of Overall Response
Time from CR or PR to progression of disease, unequivocal clinical progression, or death, whichever occurs first.
Time frame: 48 months following first randomized participant
Head and Neck Cancer Specific Event-Free Survival
Time from randomization to loco regional progression (including recurrence), distant progression, or head and neck cancer related death, as per RECIST 1.1, whichever occurs first.
Time frame: 48 months following first randomized participant
Head and Neck Cancer-Specific Survival
Time from randomization to head and neck cancer-related death.
Time frame: 48 months following first randomized participant