A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma

A Study of JNJ-90301900 in Combination With Concurrent Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma

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).

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

Exclusion criteria:

• Primary tumor originating in the nasopharynx, paranasal sinuses, salivary glands, thyroid gland, parathyroid gland, skin, or unknown primary site
• Non-squamous histology
• Stages 0, I, II, and IVC HNSCC, loco-regionally recurrent HNSCC, or synchronous second primary HNSCC (within 2 months)
• Ineligible to receive platinum-based chemotherapy
• Suspected or known allergies, hypersensitivity, or intolerance to JNJ-90301900 or its excipients