JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
- Conditions
- Locally Advanced Head and Neck Squamous Cell CarcinomaAged
- Interventions
- Registration Number
- NCT04892173
- Lead Sponsor
- Johnson & Johnson Enterprise Innovation Inc.
- 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).
- Detailed Description
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
-
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):
- 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
- Age 70-74 years old with Geriatric 8 (G8) score less than or equal to (<=) 14
- Age >= 75 years old
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A JNJ-90301900 (NBTXR3) JNJ-90301900 (NBTXR3), as an intratumoral/intranodal injection, activated by investigator's choice of RT alone or RT in combination with cetuximab. JNJ-90301900 (NBTXR3) is given as a dose of 33% of the Gross Tumor Volume. Arm A Cetuximab JNJ-90301900 (NBTXR3), as an intratumoral/intranodal injection, activated by investigator's choice of RT alone or RT in combination with cetuximab. JNJ-90301900 (NBTXR3) is given as a dose of 33% of the Gross Tumor Volume. Arm A Radiation Therapy JNJ-90301900 (NBTXR3), as an intratumoral/intranodal injection, activated by investigator's choice of RT alone or RT in combination with cetuximab. JNJ-90301900 (NBTXR3) is given as a dose of 33% of the Gross Tumor Volume. Arm B Cetuximab Investigator's choice of RT alone or RT in combination with cetuximab. Arm B Radiation Therapy Investigator's choice of RT alone or RT in combination with cetuximab.
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) 30 months following first randomized participant Time from randomization to local-regional recurrence, local-regional progression, distant progression, or death from any cause, whichever occurs first
- Secondary Outcome Measures
Name Time Method 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 or death, whichever occurs first
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)
Distant control 48 months following first randomized participant Time to distant progression: time from Randomization to distant progression or death, whichever occurs first
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
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)
Trial Locations
- Locations (166)
City of Hope
🇺🇸Duarte, California, United States
Memorial Radiation Oncology Medical Group Laguna Hills
🇺🇸Laguna Hills, California, United States
UCLA Hematology Oncology
🇺🇸Los Angeles, California, United States
Hoag Memorial Hospital
🇺🇸Newport Beach, California, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Emory University Hospital Midtown
🇺🇸Atlanta, Georgia, United States
Christus St. Vincent Regional Cancer Center
🇺🇸Santa Fe, New Mexico, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
🇺🇸New York, New York, United States
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