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).
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
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)
Time from randomization to local-regional recurrence, local-regional progression, 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 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
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
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
RECRUITINGUniversity 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 179 more locations
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
Adverse events (AEs)
Time frame: 48 months following first randomized participant