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

NCT07219212

RecruitingPhase 1

Sponsor: Johnson & Johnson Enterprise Innovation Inc.

Conditions: Squamous Cell Carcinoma of Head and Neck

Interventions: JNJ-90301900, Cisplatin, Intensity Modulated Radiation Therapy (IMRT), Carboplatin, Paclitaxel

Countries: United States, France, Japan

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 overview

Sex: ALL

Age: 18 Years to 74 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

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

Locations (17)

Birmingham, Alabama, United States
Duarte, California, United States
Jacksonville, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Boston, Massachusetts, United States
The Bronx, New York, United States
Chapel Hill, North Carolina, United States
Philadelphia, Pennsylvania, United States
Brest, France
Lille, France
Marseille, France
Rouen, France
Villejuif, France
Hiroshima, Japan
Nagoya, Japan
Tokyo, Japan