Head and Neck Squamous Cell Carcinoma (HNSCC) Clinical Trials

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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 74
Healthy Volunteers: f
View:

• 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

Locations
United States
California
City of Hope
RECRUITING
Duarte
Florida
Mayo Clinic
RECRUITING
Jacksonville
Moffit Cancer center
RECRUITING
Tampa
Georgia
Emory University
RECRUITING
Atlanta
New York
Montefiore Medical Center
RECRUITING
The Bronx
Other Locations
France
Hopital De La Cavale Blanche
RECRUITING
Brest
Centre Oscar Lambret
RECRUITING
Lille
Hopital La Timone
RECRUITING
Marseille
Centre Henri Becquerel
RECRUITING
Rouen
Gustave Roussy
RECRUITING
Villejuif
Japan
Aichi Cancer Center
RECRUITING
Nagoya
Tokyo Medical University Hospital
RECRUITING
Tokyo
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2026-01-26
Estimated Completion Date: 2028-07-14
Participants
Target number of participants: 30
Treatments
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.
Sponsors
Leads: Johnson & Johnson Enterprise Innovation Inc.

This content was sourced from clinicaltrials.gov

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