Carcinoma, Squamous Cell
Conditions
Keywords
LA-HNSCC, NBTXR3, hafnium oxide, radioenhancer, Radiotherapy, RT, HNSCC, radiation therapy
Brief 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).
Interventions
DRUGJNJ-90301900 (NBTXR3)
Suspension of inert, crystalline hafnium oxide particles, designed to generate oxygen free radicals to destroy cancer cells after activation by ionizing radiation.
DRUGCetuximab
Solution for infusion
RADIATIONRadiation Therapy
Intensity-modulated radiation therapy (IMRT): 70 Gray in 35 fractions over a 7-week period.
Sponsors
Johnson & Johnson Enterprise Innovation Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) Based on Independent Central Review (ICR) | 30 months following first randomized participant | PFS is defined as time from randomization to local-regional progression (including recurrence), distant progression, or death from any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 48 months following first randomized participant | Time from randomization to death from any cause. |
| Local-regional control | 48 months following first randomized participant | Time to local regional progression: time from randomization to local-regional progression (including recurrence) or death, whichever occurs first. |
| Distant control | 48 months following first randomized participant | Time to distant progression: time from randomization to distant progression or death, whichever occurs first. |
| Quality of Life over time - QLQ H&N35 | 48 months following first randomized participant | 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). |
| Quality of Life over time - EQ 5D 5L | 48 months following first randomized participant | Change from baseline over time in symptoms, function, and health related QOL using the 5 level EuroQol 5 dimension (EQ 5D 5L) instrument. |
| Safety across duration of study - AEs | 48 months following first randomized participant | Adverse events (AEs). |
| Objective Response Rate (ORR) | 48 months following first randomized participant | Rate of complete response (CR)+partial response (PR) \[RESIST 1.1\]. |
| Duration of Overall Response | 48 months following first randomized participant | Time from CR or PR to progression of disease, unequivocal clinical progression, or death, whichever occurs first. |
| Head and Neck Cancer Specific Event-Free Survival | 48 months following first randomized participant | 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. |
| Head and Neck Cancer-Specific Survival | 48 months following first randomized participant | Time from randomization to head and neck cancer-related death. |
Countries
Austria, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czechia, Finland, France, Georgia, Germany, Greece, Hungary, India, Israel, Japan, Philippines, Portugal, Romania, Serbia, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJohnson & Johnson Enterprise Innovation Inc Clinical trial
Johnson & Johnson Enterprise Innovation Inc.
Outcome results
None listed