A Study of JNJ-90301900 in Combination With Concurrent Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma
Johnson & Johnson Enterprise Innovation Inc.
Summary
This global, open-label, single arm, phase 1b study aims to learn more about whether a treatment called JNJ-90301900 is safe and effective when injected directly into tumors, along with standard chemotherapy and radiation therapy, for participants with head and neck squamous cell cancer (HNSCC; a type of solid tumor that begins in outer tissue layer of the mouth \& throat).
Eligibility
- Age range
- 18–74 years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: * Pathologically (histologically or cytologically) proven diagnosis of HNSCC of the oral cavity, oropharynx (p16 negative), hypopharynx, or supraglottic larynx * Stage III, IVA or IVB according to the 8th Edition of the American Joint Committee on Cancer (AJCC) guidelines * A candidate for definitive concurrent chemoradiation therapy treatment as determined by investigator and per local guidelines * Participants must have at least 1 target lesion (primary tumor or involved lymph node) per RECIST v.1.1 * Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1…
Interventions
- DrugJNJ-90301900
JNJ-90301900 will administered via intratumoral and/or intranodal injection.
- DrugCisplatin
Cisplatin will be administered intravenously.
- RadiationIntensity Modulated Radiation Therapy (IMRT)
IMRT radiation therapy will be administered.
Locations (16)
- University of Alabama at BirminghamBirmingham, Alabama
- City of HopeDuarte, California
- Mayo ClinicJacksonville, Florida
- Moffit Cancer centerTampa, Florida
- Emory UniversityAtlanta, Georgia
- Boston Medical CenterBoston, Massachusetts