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

Detailed criteria

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

Drug
JNJ-90301900
JNJ-90301900 will administered via intratumoral and/or intranodal injection.
Drug
Cisplatin
Cisplatin will be administered intravenously.
Radiation
Intensity Modulated Radiation Therapy (IMRT)
IMRT radiation therapy will be administered.
Drug
Carboplatin
Carboplatin will be administered intravenously.
Drug
Paclitaxel
Paclitaxel will be administered intravenously.

Summary

Eligibility

Interventions

Locations (20)