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).
Brief Title
JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
844-434-4210
Central Contact Email
Participate-In-This-Study1@its.jnj.com
Completion Date
Completion Date Type
Estimated
Conditions
Carcinoma, Squamous Cell
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Keywords
LA-HNSCC
NBTXR3
hafnium oxide
radioenhancer
Radiotherapy
RT
HNSCC
radiation therapy
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
60 Years
NCT Id
NCT04892173
Org Class
Industry
Org Full Name
Johnson & Johnson Enterprise Innovation Inc.
Org Study Id
NANORAY-312
Overall Status
Recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
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 Locally Advanced Head & Neck Squamous Cell Carcinoma
Primary Outcomes
Outcome Description
PFS is defined as time from randomization to local-regional progression (including recurrence), distant progression, or death from any cause, whichever occurs first.
Outcome Measure
Progression-free Survival (PFS) Based on Independent Central Review (ICR)
Outcome Time Frame
30 months following first randomized participant
Secondary Ids
Secondary Id
NANORAY-312
Secondary Id
2024-520386-31-00
Secondary Outcomes
Outcome Description
Time from randomization to death from any cause.
Outcome Time Frame
48 months following first randomized participant
Outcome Measure
Overall Survival (OS)
Outcome Description
Time to local regional progression: time from randomization to local-regional progression (including recurrence) or death, whichever occurs first.
Outcome Time Frame
48 months following first randomized participant
Outcome Measure
Local-regional control
Outcome Description
Time to distant progression: time from randomization to distant progression or death, whichever occurs first.
Outcome Time Frame
48 months following first randomized participant
Outcome Measure
Distant control
Outcome Description
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).
Outcome Time Frame
48 months following first randomized participant
Outcome Measure
Quality of Life over time - QLQ H&N35
Outcome Description
Change from baseline over time in symptoms, function, and health related QOL using the 5 level EuroQol 5 dimension (EQ 5D 5L) instrument.
Outcome Time Frame
48 months following first randomized participant
Outcome Measure
Quality of Life over time - EQ 5D 5L
Outcome Description
Adverse events (AEs).
Outcome Time Frame
48 months following first randomized participant
Outcome Measure
Safety across duration of study - AEs
Outcome Description
Rate of complete response (CR)+partial response (PR) \[RESIST 1.1\].
Outcome Time Frame
48 months following first randomized participant
Outcome Measure
Objective Response Rate (ORR)
Outcome Description
Time from CR or PR to progression of disease, unequivocal clinical progression, or death, whichever occurs first.
Outcome Time Frame
48 months following first randomized participant
Outcome Measure
Duration of Overall Response
Outcome Description
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.
Outcome Time Frame
48 months following first randomized participant
Outcome Measure
Head and Neck Cancer Specific Event-Free Survival
Outcome Description
Time from randomization to head and neck cancer-related death.
Outcome Time Frame
48 months following first randomized participant
Outcome Measure
Head and Neck Cancer-Specific Survival
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
60
Investigators
Investigator Type
Principal Investigator
Investigator Name
Rafi Kabarriti
Investigator Email
RKABARRI@MONTEFIORE.ORG
Investigator Department
Radiation Oncology
Investigator Sponsor Organization
External
Study Department
Radiation Oncology
Study Division
Radiation Oncology
Categories Mesh Debug
Cancer --- CARCINOMA
Cancer --- NEOPLASMS
Cancer --- NEOPLASMS BY SITE
MeSH Terms
CARCINOMA, SQUAMOUS CELL
SQUAMOUS CELL CARCINOMA OF HEAD AND NECK
CARCINOMA
NEOPLASMS, GLANDULAR AND EPITHELIAL
NEOPLASMS BY HISTOLOGIC TYPE
NEOPLASMS
NEOPLASMS, SQUAMOUS CELL
HEAD AND NECK NEOPLASMS
NEOPLASMS BY SITE
CETUXIMAB
RADIOTHERAPY
ANTIBODIES, MONOCLONAL, HUMANIZED
ANTIBODIES, MONOCLONAL
ANTIBODIES
IMMUNOGLOBULINS
IMMUNOPROTEINS
BLOOD PROTEINS
PROTEINS
AMINO ACIDS, PEPTIDES, AND PROTEINS
SERUM GLOBULINS
GLOBULINS
THERAPEUTICS