JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Johnson & Johnson Enterprise Innovation Inc.
Study ID
NCT04892173
Phase
PHASE3
Status
Recruiting
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Conditions

  • Carcinoma, Squamous Cell

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JNJ-90301900 (NBTXR3) — DRUG
    Suspension of inert, crystalline hafnium oxide particles, designed to generate oxygen free radicals to destroy cancer cells after activation by ionizing radiation.
  • Cetuximab — DRUG
    Solution for infusion
  • Radiation Therapy — RADIATION
    Intensity-modulated radiation therapy (IMRT): 70 Gray in 35 fractions over a 7-week period.

Study Details

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).

Key Dates

Start date
Dec 10, 2021
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: Arm B: RT alone or RT in combination with cetuximab
    Investigator's choice of RT alone or RT in combination with cetuximab.

Primary Outcome Measure

Progression-free Survival (PFS) Based on Independent Central Review (ICR) [ Time Frame: 30 months following first randomized participant ]

Central Contacts

Locations (26)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
City of HopeDuarteCalifornia91010-
University of California at San Diego Moores Cancer CenterLa JollaCalifornia92093-
Memorial Radiation Oncology Medical Group Laguna HillsLaguna HillsCalifornia92653-
UCLA Hematology OncologyLos AngelesCalifornia90095-
Hoag Memorial HospitalNewport BeachCalifornia92663-
University of California San FranciscoSan FranciscoCalifornia94158-
George Washington University Cancer CenterWashington D.C.District of Columbia20052-
Mayo Clinic JacksonvilleJacksonvilleFlorida32224-
AdventHealth OrlandoOrlandoFlorida32803-
Moffitt Cancer CenterTampaFlorida33612-
Emory University Hospital MidtownAtlantaGeorgia30308-
University of Kentucky Markey Cancer CenterLexingtonKentucky40536-
Boston Medical CenterBostonMassachusetts02118-
Christus St. Vincent Regional Cancer CenterSanta FeNew Mexico87505-
Herbert Irving Comprehensive Cancer Center Columbia University Medical CenterNew YorkNew York10032-
Richmond University Medical CenterStaten IslandNew York10310-
Montefiore Medical CenterThe BronxNew York10467-
University of North Carolina at Chapel HillChapel HillNorth Carolina27514-
Atrium Health Levine Cancer InstituteCharlotteNorth Carolina28204-
University of CincinnatiCincinnatiOhio45219-
Stephenson Cancer CenterOklahoma CityOklahoma73104-
Oregon Health And Science UniversityPortlandOregon97239-
University of Pennsylvania Perelman Center for Advanced MedicinePhiladelphiaPennsylvania19104-
University of VirginiaCharlottesvilleVirginia22908-
Macon Joan Brock Virginia Health Sciences Eastern Virginia Medical Group at Old Dominion UniversityNorfolkVirginia23507-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALCity of Hope· Duarte, CAUniversity of California at San Diego Moores Cancer Center· La Jolla, CAMemorial Radiation Oncology Medical Group Laguna Hills· Laguna Hills, CAUCLA Hematology Oncology· Los Angeles, CAHoag Memorial Hospital· Newport Beach, CA

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