A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma
Purpose
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).
Condition
- Squamous Cell Carcinoma of Head and Neck
Eligibility
- Eligible Ages
- Between 18 Years and 74 Years
- Eligible Sex
- All
- Accepts 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
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 cisplatin chemotherapy - Suspected or known allergies, hypersensitivity, or intolerance to JNJ-90301900 or its excipients
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT) |
Participants will receive JNJ-90301900 administered intratumorally and/or intranodally, in combination with concurrent chemoradiation therapy (cCRT) consisting of cisplatin and intensity-modulated radiation therapy (IMRT). Post-treatment follow-up will continue until the end of study (EOS), radiographic disease progression, study discontinuation, or study completion, whichever occurs first. |
|
Recruiting Locations
Boston Medical Center
Boston, Massachusetts 02118
Boston, Massachusetts 02118
More Details
- Status
- Recruiting
- Sponsor
- Johnson & Johnson Enterprise Innovation Inc.